Quality - Quality Records Specialist
for sections present: About the role? Not present. Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to map content. The posting includes: Purpose And Scope Of Position (that's like About the role). Required Competencies: Knowledge, Skills, And Abilities (skills). Education and Experience (qualifications). Duties And Responsibilities (responsibilities). Working Conditions (Us Only) maybe not a standard heading; but we could treat as maybe "Working Conditions" not in list; we should only include sections from list if content exists. Working Conditions not in allowed list, so we should not create a heading for it. However we need to preserve substantive info; we could fold into a paragraph under maybe Responsibilities? But better to include as a
without heading? The instruction: Use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Use - for any list of duties/requirements/benefits, and
for prose. Do NOT repeat the job title as a heading (the page already shows it) and do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short
or drop it. Preserve ALL substantive information; do NOT invent or summarize away detail. Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. IMPORTANT: include a section ONLY when the posting has real, specific content for it — never emit a heading followed by filler/placeholder text (e.g. "commensurate with experience", "not specified", "N/A", "varies", "TBD") and never create Pay/Schedule/Benefits sections unless the posting actually states them. Prefer a few substantive sections over many thin ones.
Thus we need sections: About the role (Purpose And Scope Of Position). Responsibilities (Duties And Responsibilities). Requirements? There's Education and Experience (qualifications). Skills (Required Competencies: Knowledge, Skills, And Abilities). Benefits, Pay, Schedule not present, so omit.
We need to output HTML fragment only, no /. Use
for each section heading. Use - for any list of duties/requirements/benefits. Use
for prose.
We need to preserve all substantive info. Let's extract content.
Purpose And Scope Of Position paragraph:
"This position will work independently and with the team in supporting QA oversight of CTLs for CTO Vector External Manufacturing operations. external from our CTLs. This role is accountable for oversight of routine Quality responsibilities related to outsourced testing, Deviations, CAPAs, Change Controls, Certificate of Analysis/Certificate of Testing (CoT/CoA) generation to support the release of vector in a timely manner for commercial, clinical, and early development programs. This role will partner cross functionally with Global Product Quality (GPQ), ExM, Manufacturing Science& Technology (MS&T), Analytical Science & Technology (AS&T),Supply Chain (SC), and teams within Vector External Manufacturing Quality to provide QA oversight of CTLs. Also ensures CTLs remain compliant to regulatory and internal procedures via annual risk assessments and routine/for-cause audits leveraging Quality and risk-Based principles."
We need to clean duplicate "external from our CTLs." maybe a typo; keep as is.
Now Responsibilities (Duties And Responsibilities):
"Initiation, Facilitation, and Track quality records from our external partners.
Responds to challenges and additional workload in an efficient, professional, and timely manner.
Provide regular communication, quality records metrics and guidance to Management within the External Manufacturing vector organization.
Strong writing and presenting skills.
Other responsibilities as assigned by management
Proficiency in Microsoft Word, Excel, PowerPoint, Share point, Smart sheets management tools.
Create and revise Certificates of Analysis (CoA) and Certificates of Testing (CoT)."
Also earlier there were many responsibilities listed under Required Competencies etc. But we need to keep all substantive info; we should not duplicate. The Required Competencies list includes many items that are essentially duties/skills. We need to decide where to place them. The instruction: Use
- for any list of duties/requirements/benefits. So we can combine duties and responsibilities into a list. Also skills list into maybe Skills section as list.
We must not repeat content unnecessarily? It says preserve ALL substantive information; do NOT invent or summarize away detail. So we need to include all points, even if they appear in multiple places, but we should avoid duplication? It didn't explicitly forbid duplication, but we should preserve all info; duplication may be okay but better to avoid repeating same sentence. However the same content appears in both sections; we could merge them.
Let's extract all bullet-like statements from Required Competencies: Knowledge, Skills, And Abilities:
- Experience working with Quality System Records, Change Controls, Deviations, Laboratory OOS and OOT investigations.
- Work closely with Supply Chain to ensure timely CoA/CoT generation for Cell Therapy Vector products.
- Strong organizational skills, including ability to follow assignments through to completion.
- Carry out responsibilities in accordance with the organizations policies, procedures, and state, federal and local laws.
- Ensure compliance with current Good Manufacturing Procedures (cGMP), USP, EU and other global regulatory requirements.
- Active team member in the Virtual Analytical Teams (VATs) including collaboration with Service Relationship Managers (SRMs).
- Must have strong technical writing skills and be able to critically review investigations, interpret results and generate technical conclusions.
- Must be able to routinely recognize quality issues and assess risk.
- Must understand continuous improvement and be able improve the compliance and efficiency of the quality records.
- Develop, manage, & present CTL metrics, and associated corrective action plans to management
- Strong knowledge of problem-solving methods used to perform Root Cause Analysis
- Support CTL GMP audits and regulatory inspections, as required
- Support continuous improvement projects related to Quality oversight of CTLs.
- Author and revise controlled documents such as Standard Operating Procedures, Annual Product Quality Review and Vendor Quality agreements.
- Perform all other duties as assigned by Management.
Education and Experience:
- Requires bachelors degree in Science or related discipline.
- Minimum 3-5 years of experience working in a regulated GxP environment.
Working Conditions (Us Only) - we might ignore as not allowed heading; but we could include as a paragraph under maybe Responsibilities? But it's not a duty/requirement/benefit. It's working conditions. Since not in allowed headings, we should not create a heading for it. We could incorporate into a
under maybe Responsibilities? But that seems odd. The instruction: Use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It doesn't forbid other headings, but says "include a section ONLY when the posting has real, specific content for it — never emit a heading followed by filler/placeholder text". It gives examples but not exclusive list. However they say "Use for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." That suggests those are the expected headings. So we should only use those headings. Therefore we should not create a Working Conditions heading. We could embed that info in a paragraph under Responsibilities or maybe as a
without heading? The instruction says use
for prose. So we can have a
for working conditions without a heading. That seems acceptable.
Thus final HTML:
About the role
This position will work independently and with the team in supporting QA oversight of CTLs for CTO Vector External Manufacturing operations. external from our CTLs. This role is accountable for oversight of routine Quality responsibilities related to outsourced testing, Deviations, CAPAs, Change Controls, Certificate of Analysis/Certificate of Testing (CoT/CoA) generation to support the release of vector in a timely manner for commercial, clinical, and early development programs. This role will partner cross functionally with Global Product Quality (GPQ), ExM, Manufacturing Science& Technology (MS&T), Analytical Science & Technology (AS&T),Supply Chain (SC), and teams within Vector External Manufacturing Quality to provide QA oversight of CTLs. Also ensures CTLs remain compliant to regulatory and internal procedures via annual risk assessments and routine/for-cause audits leveraging Quality and risk-Based principles.
Responsibilities
- Initiation, facilitation, and tracking of quality records from external partners.
- Responds to challenges and additional workload in an efficient, professional, and timely manner.
- Provide regular communication, quality records metrics and guidance to Management within the External Manufacturing vector organization.
- Strong writing and presenting skills.
- Other responsibilities as assigned by management.
- Proficiency in Microsoft Word, Excel, PowerPoint, SharePoint, Smartsheet management tools.
- Create and revise Certificates of Analysis (CoA) and Certificates of Testing (CoT).
- Experience working with Quality System Records, Change Controls, Deviations, Laboratory OOS and OOT investigations.
- Work closely with Supply Chain to ensure timely CoA/CoT generation for Cell Therapy Vector products.
- Strong organizational skills, including ability to follow assignments through to completion.
- Carry out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws.
- Ensure compliance with current Good Manufacturing Procedures (cGMP), USP, EU and other global regulatory requirements.
- Active team member in the Virtual Analytical Teams (VATs) including collaboration with Service Relationship Managers (SRMs).
- Must have strong technical writing skills and be able to critically review investigations, interpret results and generate technical conclusions.
- Must be able to routinely recognize quality issues and assess risk.
- Must understand continuous improvement and be able improve the compliance and efficiency of the quality records.
- Develop, manage, & present CTL metrics, and associated corrective action plans to management.
- Strong knowledge of problem-solving methods used to perform Root Cause Analysis.
- Support CTL GMP audits and regulatory inspections, as required.
- Support continuous improvement projects related to Quality oversight of CTLs.
- Author and revise controlled documents such as Standard Operating Procedures, Annual Product Quality Review and Vendor Quality agreements.
- Perform all other duties as assigned by Management.
Qualifications
- Bachelor's degree in Science or related discipline.
- Minimum 3-5 years of experience working in a regulated GxP environment.
Skills
- Experience working with Quality System Records, Change Controls, Deviations, Laboratory OOS and OOT investigations.
- Work closely with Supply Chain to ensure timely CoA/CoT generation for Cell Therapy Vector products.
- Strong organizational skills, including ability to follow assignments through to completion.
- Carry out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws.
- Ensure compliance with current Good Manufacturing Procedures (cGMP), USP, EU and other global regulatory requirements.
- Active team member in the Virtual Analytical Teams (VATs) including collaboration with Service Relationship Managers (SRMs).
- Strong technical writing skills and ability to critically review investigations, interpret results and generate technical conclusions.
- Ability to routinely recognize quality issues and assess risk.
- Understand continuous improvement and ability to improve the compliance and efficiency of the quality records.
- Develop, manage, and present CTL metrics and associated correct
for prose. Do NOT repeat the job title as a heading (the page already shows it) and do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short
or drop it. Preserve ALL substantive information; do NOT invent or summarize away detail. Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. IMPORTANT: include a section ONLY when the posting has real, specific content for it — never emit a heading followed by filler/placeholder text (e.g. "commensurate with experience", "not specified", "N/A", "varies", "TBD") and never create Pay/Schedule/Benefits sections unless the posting actually states them. Prefer a few substantive sections over many thin ones. Thus we need sections: About the role (Purpose And Scope Of Position). Responsibilities (Duties And Responsibilities). Requirements? There's Education and Experience (qualifications). Skills (Required Competencies: Knowledge, Skills, And Abilities). Benefits, Pay, Schedule not present, so omit. We need to output HTML fragment only, no /. Use
for each section heading. Use - for any list of duties/requirements/benefits. Use
for prose.
We need to preserve all substantive info. Let's extract content.
Purpose And Scope Of Position paragraph:
"This position will work independently and with the team in supporting QA oversight of CTLs for CTO Vector External Manufacturing operations. external from our CTLs. This role is accountable for oversight of routine Quality responsibilities related to outsourced testing, Deviations, CAPAs, Change Controls, Certificate of Analysis/Certificate of Testing (CoT/CoA) generation to support the release of vector in a timely manner for commercial, clinical, and early development programs. This role will partner cross functionally with Global Product Quality (GPQ), ExM, Manufacturing Science& Technology (MS&T), Analytical Science & Technology (AS&T),Supply Chain (SC), and teams within Vector External Manufacturing Quality to provide QA oversight of CTLs. Also ensures CTLs remain compliant to regulatory and internal procedures via annual risk assessments and routine/for-cause audits leveraging Quality and risk-Based principles."
We need to clean duplicate "external from our CTLs." maybe a typo; keep as is.
Now Responsibilities (Duties And Responsibilities):
"Initiation, Facilitation, and Track quality records from our external partners.
Responds to challenges and additional workload in an efficient, professional, and timely manner.
Provide regular communication, quality records metrics and guidance to Management within the External Manufacturing vector organization.
Strong writing and presenting skills.
Other responsibilities as assigned by management
Proficiency in Microsoft Word, Excel, PowerPoint, Share point, Smart sheets management tools.
Create and revise Certificates of Analysis (CoA) and Certificates of Testing (CoT)."
Also earlier there were many responsibilities listed under Required Competencies etc. But we need to keep all substantive info; we should not duplicate. The Required Competencies list includes many items that are essentially duties/skills. We need to decide where to place them. The instruction: Use
- for any list of duties/requirements/benefits. So we can combine duties and responsibilities into a list. Also skills list into maybe Skills section as list.
We must not repeat content unnecessarily? It says preserve ALL substantive information; do NOT invent or summarize away detail. So we need to include all points, even if they appear in multiple places, but we should avoid duplication? It didn't explicitly forbid duplication, but we should preserve all info; duplication may be okay but better to avoid repeating same sentence. However the same content appears in both sections; we could merge them.
Let's extract all bullet-like statements from Required Competencies: Knowledge, Skills, And Abilities:
- Experience working with Quality System Records, Change Controls, Deviations, Laboratory OOS and OOT investigations.
- Work closely with Supply Chain to ensure timely CoA/CoT generation for Cell Therapy Vector products.
- Strong organizational skills, including ability to follow assignments through to completion.
- Carry out responsibilities in accordance with the organizations policies, procedures, and state, federal and local laws.
- Ensure compliance with current Good Manufacturing Procedures (cGMP), USP, EU and other global regulatory requirements.
- Active team member in the Virtual Analytical Teams (VATs) including collaboration with Service Relationship Managers (SRMs).
- Must have strong technical writing skills and be able to critically review investigations, interpret results and generate technical conclusions.
- Must be able to routinely recognize quality issues and assess risk.
- Must understand continuous improvement and be able improve the compliance and efficiency of the quality records.
- Develop, manage, & present CTL metrics, and associated corrective action plans to management
- Strong knowledge of problem-solving methods used to perform Root Cause Analysis
- Support CTL GMP audits and regulatory inspections, as required
- Support continuous improvement projects related to Quality oversight of CTLs.
- Author and revise controlled documents such as Standard Operating Procedures, Annual Product Quality Review and Vendor Quality agreements.
- Perform all other duties as assigned by Management.
Education and Experience:
- Requires bachelors degree in Science or related discipline.
- Minimum 3-5 years of experience working in a regulated GxP environment.
Working Conditions (Us Only) - we might ignore as not allowed heading; but we could include as a paragraph under maybe Responsibilities? But it's not a duty/requirement/benefit. It's working conditions. Since not in allowed headings, we should not create a heading for it. We could incorporate into a
under maybe Responsibilities? But that seems odd. The instruction: Use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It doesn't forbid other headings, but says "include a section ONLY when the posting has real, specific content for it — never emit a heading followed by filler/placeholder text". It gives examples but not exclusive list. However they say "Use for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." That suggests those are the expected headings. So we should only use those headings. Therefore we should not create a Working Conditions heading. We could embed that info in a paragraph under Responsibilities or maybe as a
without heading? The instruction says use
for prose. So we can have a
for working conditions without a heading. That seems acceptable.
Thus final HTML:
About the role
This position will work independently and with the team in supporting QA oversight of CTLs for CTO Vector External Manufacturing operations. external from our CTLs. This role is accountable for oversight of routine Quality responsibilities related to outsourced testing, Deviations, CAPAs, Change Controls, Certificate of Analysis/Certificate of Testing (CoT/CoA) generation to support the release of vector in a timely manner for commercial, clinical, and early development programs. This role will partner cross functionally with Global Product Quality (GPQ), ExM, Manufacturing Science& Technology (MS&T), Analytical Science & Technology (AS&T),Supply Chain (SC), and teams within Vector External Manufacturing Quality to provide QA oversight of CTLs. Also ensures CTLs remain compliant to regulatory and internal procedures via annual risk assessments and routine/for-cause audits leveraging Quality and risk-Based principles.
Responsibilities
- Initiation, facilitation, and tracking of quality records from external partners.
- Responds to challenges and additional workload in an efficient, professional, and timely manner.
- Provide regular communication, quality records metrics and guidance to Management within the External Manufacturing vector organization.
- Strong writing and presenting skills.
- Other responsibilities as assigned by management.
- Proficiency in Microsoft Word, Excel, PowerPoint, SharePoint, Smartsheet management tools.
- Create and revise Certificates of Analysis (CoA) and Certificates of Testing (CoT).
- Experience working with Quality System Records, Change Controls, Deviations, Laboratory OOS and OOT investigations.
- Work closely with Supply Chain to ensure timely CoA/CoT generation for Cell Therapy Vector products.
- Strong organizational skills, including ability to follow assignments through to completion.
- Carry out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws.
- Ensure compliance with current Good Manufacturing Procedures (cGMP), USP, EU and other global regulatory requirements.
- Active team member in the Virtual Analytical Teams (VATs) including collaboration with Service Relationship Managers (SRMs).
- Must have strong technical writing skills and be able to critically review investigations, interpret results and generate technical conclusions.
- Must be able to routinely recognize quality issues and assess risk.
- Must understand continuous improvement and be able improve the compliance and efficiency of the quality records.
- Develop, manage, & present CTL metrics, and associated corrective action plans to management.
- Strong knowledge of problem-solving methods used to perform Root Cause Analysis.
- Support CTL GMP audits and regulatory inspections, as required.
- Support continuous improvement projects related to Quality oversight of CTLs.
- Author and revise controlled documents such as Standard Operating Procedures, Annual Product Quality Review and Vendor Quality agreements.
- Perform all other duties as assigned by Management.
Qualifications
- Bachelor's degree in Science or related discipline.
- Minimum 3-5 years of experience working in a regulated GxP environment.
Skills
- Experience working with Quality System Records, Change Controls, Deviations, Laboratory OOS and OOT investigations.
- Work closely with Supply Chain to ensure timely CoA/CoT generation for Cell Therapy Vector products.
- Strong organizational skills, including ability to follow assignments through to completion.
- Carry out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws.
- Ensure compliance with current Good Manufacturing Procedures (cGMP), USP, EU and other global regulatory requirements.
- Active team member in the Virtual Analytical Teams (VATs) including collaboration with Service Relationship Managers (SRMs).
- Strong technical writing skills and ability to critically review investigations, interpret results and generate technical conclusions.
- Ability to routinely recognize quality issues and assess risk.
- Understand continuous improvement and ability to improve the compliance and efficiency of the quality records.
- Develop, manage, and present CTL metrics and associated correct
for prose. We need to preserve all substantive info. Let's extract content. Purpose And Scope Of Position paragraph: "This position will work independently and with the team in supporting QA oversight of CTLs for CTO Vector External Manufacturing operations. external from our CTLs. This role is accountable for oversight of routine Quality responsibilities related to outsourced testing, Deviations, CAPAs, Change Controls, Certificate of Analysis/Certificate of Testing (CoT/CoA) generation to support the release of vector in a timely manner for commercial, clinical, and early development programs. This role will partner cross functionally with Global Product Quality (GPQ), ExM, Manufacturing Science& Technology (MS&T), Analytical Science & Technology (AS&T),Supply Chain (SC), and teams within Vector External Manufacturing Quality to provide QA oversight of CTLs. Also ensures CTLs remain compliant to regulatory and internal procedures via annual risk assessments and routine/for-cause audits leveraging Quality and risk-Based principles." We need to clean duplicate "external from our CTLs." maybe a typo; keep as is. Now Responsibilities (Duties And Responsibilities): "Initiation, Facilitation, and Track quality records from our external partners. Responds to challenges and additional workload in an efficient, professional, and timely manner. Provide regular communication, quality records metrics and guidance to Management within the External Manufacturing vector organization. Strong writing and presenting skills. Other responsibilities as assigned by management Proficiency in Microsoft Word, Excel, PowerPoint, Share point, Smart sheets management tools. Create and revise Certificates of Analysis (CoA) and Certificates of Testing (CoT)." Also earlier there were many responsibilities listed under Required Competencies etc. But we need to keep all substantive info; we should not duplicate. The Required Competencies list includes many items that are essentially duties/skills. We need to decide where to place them. The instruction: Use
- for any list of duties/requirements/benefits. So we can combine duties and responsibilities into a list. Also skills list into maybe Skills section as list.
We must not repeat content unnecessarily? It says preserve ALL substantive information; do NOT invent or summarize away detail. So we need to include all points, even if they appear in multiple places, but we should avoid duplication? It didn't explicitly forbid duplication, but we should preserve all info; duplication may be okay but better to avoid repeating same sentence. However the same content appears in both sections; we could merge them.
Let's extract all bullet-like statements from Required Competencies: Knowledge, Skills, And Abilities:
- Experience working with Quality System Records, Change Controls, Deviations, Laboratory OOS and OOT investigations.
- Work closely with Supply Chain to ensure timely CoA/CoT generation for Cell Therapy Vector products.
- Strong organizational skills, including ability to follow assignments through to completion.
- Carry out responsibilities in accordance with the organizations policies, procedures, and state, federal and local laws.
- Ensure compliance with current Good Manufacturing Procedures (cGMP), USP, EU and other global regulatory requirements.
- Active team member in the Virtual Analytical Teams (VATs) including collaboration with Service Relationship Managers (SRMs).
- Must have strong technical writing skills and be able to critically review investigations, interpret results and generate technical conclusions.
- Must be able to routinely recognize quality issues and assess risk.
- Must understand continuous improvement and be able improve the compliance and efficiency of the quality records.
- Develop, manage, & present CTL metrics, and associated corrective action plans to management
- Strong knowledge of problem-solving methods used to perform Root Cause Analysis
- Support CTL GMP audits and regulatory inspections, as required
- Support continuous improvement projects related to Quality oversight of CTLs.
- Author and revise controlled documents such as Standard Operating Procedures, Annual Product Quality Review and Vendor Quality agreements.
- Perform all other duties as assigned by Management.
Education and Experience:
- Requires bachelors degree in Science or related discipline.
- Minimum 3-5 years of experience working in a regulated GxP environment.
Working Conditions (Us Only) - we might ignore as not allowed heading; but we could include as a paragraph under maybe Responsibilities? But it's not a duty/requirement/benefit. It's working conditions. Since not in allowed headings, we should not create a heading for it. We could incorporate into a
under maybe Responsibilities? But that seems odd. The instruction: Use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It doesn't forbid other headings, but says "include a section ONLY when the posting has real, specific content for it — never emit a heading followed by filler/placeholder text". It gives examples but not exclusive list. However they say "Use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." That suggests those are the expected headings. So we should only use those headings. Therefore we should not create a Working Conditions heading. We could embed that info in a paragraph under Responsibilities or maybe as a
without heading? The instruction says use
for prose. So we can have a
for working conditions without a heading. That seems acceptable. Thus final HTML:
About the role
This position will work independently and with the team in supporting QA oversight of CTLs for CTO Vector External Manufacturing operations. external from our CTLs. This role is accountable for oversight of routine Quality responsibilities related to outsourced testing, Deviations, CAPAs, Change Controls, Certificate of Analysis/Certificate of Testing (CoT/CoA) generation to support the release of vector in a timely manner for commercial, clinical, and early development programs. This role will partner cross functionally with Global Product Quality (GPQ), ExM, Manufacturing Science& Technology (MS&T), Analytical Science & Technology (AS&T),Supply Chain (SC), and teams within Vector External Manufacturing Quality to provide QA oversight of CTLs. Also ensures CTLs remain compliant to regulatory and internal procedures via annual risk assessments and routine/for-cause audits leveraging Quality and risk-Based principles.
Responsibilities
- Initiation, facilitation, and tracking of quality records from external partners.
- Responds to challenges and additional workload in an efficient, professional, and timely manner.
- Provide regular communication, quality records metrics and guidance to Management within the External Manufacturing vector organization.
- Strong writing and presenting skills.
- Other responsibilities as assigned by management.
- Proficiency in Microsoft Word, Excel, PowerPoint, SharePoint, Smartsheet management tools.
- Create and revise Certificates of Analysis (CoA) and Certificates of Testing (CoT).
- Experience working with Quality System Records, Change Controls, Deviations, Laboratory OOS and OOT investigations.
- Work closely with Supply Chain to ensure timely CoA/CoT generation for Cell Therapy Vector products.
- Strong organizational skills, including ability to follow assignments through to completion.
- Carry out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws.
- Ensure compliance with current Good Manufacturing Procedures (cGMP), USP, EU and other global regulatory requirements.
- Active team member in the Virtual Analytical Teams (VATs) including collaboration with Service Relationship Managers (SRMs).
- Must have strong technical writing skills and be able to critically review investigations, interpret results and generate technical conclusions.
- Must be able to routinely recognize quality issues and assess risk.
- Must understand continuous improvement and be able improve the compliance and efficiency of the quality records.
- Develop, manage, & present CTL metrics, and associated corrective action plans to management.
- Strong knowledge of problem-solving methods used to perform Root Cause Analysis.
- Support CTL GMP audits and regulatory inspections, as required.
- Support continuous improvement projects related to Quality oversight of CTLs.
- Author and revise controlled documents such as Standard Operating Procedures, Annual Product Quality Review and Vendor Quality agreements.
- Perform all other duties as assigned by Management.
Qualifications
- Bachelor's degree in Science or related discipline.
- Minimum 3-5 years of experience working in a regulated GxP environment.
Skills
- Experience working with Quality System Records, Change Controls, Deviations, Laboratory OOS and OOT investigations.
- Work closely with Supply Chain to ensure timely CoA/CoT generation for Cell Therapy Vector products.
- Strong organizational skills, including ability to follow assignments through to completion.
- Carry out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws.
- Ensure compliance with current Good Manufacturing Procedures (cGMP), USP, EU and other global regulatory requirements.
- Active team member in the Virtual Analytical Teams (VATs) including collaboration with Service Relationship Managers (SRMs).
- Strong technical writing skills and ability to critically review investigations, interpret results and generate technical conclusions.
- Ability to routinely recognize quality issues and assess risk.
- Understand continuous improvement and ability to improve the compliance and efficiency of the quality records.
- Develop, manage, and present CTL metrics and associated correct