Quality Systems Associate
Grifols · Texas, United States · 1 mo ago
Information TechnologyFull-time
We need to output HTML fragment with sections: About the role? The posting includes intro about Grifols, then "Quality Systems Associate Summary:" etc. We need to use for section headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We must include sections only when posting has real specific content. No Pay/Schedule/Benefits unless stated. There's no explicit pay, schedule, benefits. So we should not create those sections.
We need to preserve all substantive info, remove boilerplate (cookie/navigation/legal/EEO etc). The posting includes a lot of details: responsibilities, duties, knowledge, skills, abilities, education, experience, occupational demands, location, etc.
We need to structure into sections: maybe "About the role" (intro about Grifols and role summary), "Responsibilities" (list of duties), "Requirements" (education, experience, certifications), "Qualifications" maybe overlapping; but we can combine. The instruction: Use headings for those specific labels if content exists. We need to decide which sections to include.
We have content: Intro paragraph about Grifols and role summary. That could be "About the role". Then responsibilities: many bullet-like sentences. We can put them in
for section headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We must include sections only when posting has real specific content. No Pay/Schedule/Benefits unless stated. There's no explicit pay, schedule, benefits. So we should not create those sections.
We need to preserve all substantive info, remove boilerplate (cookie/navigation/legal/EEO etc). The posting includes a lot of details: responsibilities, duties, knowledge, skills, abilities, education, experience, occupational demands, location, etc.
We need to structure into sections: maybe "About the role" (intro about Grifols and role summary), "Responsibilities" (list of duties), "Requirements" (education, experience, certifications), "Qualifications" maybe overlapping; but we can combine. The instruction: Use headings for those specific labels if content exists. We need to decide which sections to include.
We have content: Intro paragraph about Grifols and role summary. That could be "About the role". Then responsibilities: many bullet-like sentences. We can put them in - . Then requirements: Education, Experience, certification, licensure. Also Knowledge, Skills, Abilities could be "Skills". Also "Qualifications" maybe for knowledge, skills, abilities. But we should avoid duplication. Perhaps we have sections: About the role, Responsibilities, Requirements (education/experience), Skills (knowledge, skills, abilities), Qualifications (maybe cGMP understanding). But we need to follow instruction: "Prefer a few substantive sections over many thin ones." So maybe combine into About the role, Responsibilities, Requirements (including education, experience, certifications), Skills (knowledge, skills, abilities). Avoid Qualifications if overlapping.
We must not repeat job title as heading. No Job ID etc.
We must remove boilerplate: The lines about "Third Party Agency And Recruiter Notice", EEO statement, "Learn more about Grifols". Also "Occupational Demands Form # 70:" maybe keep as part of requirements? It's substantive about work environment; could be part of Requirements or maybe a separate section "Working Conditions". But we only have allowed headings list; we could put under Requirements or maybe create a section "Working Conditions" not in list; but instruction says use those headings for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It doesn't forbid other headings? It says "use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." The e.g. suggests those are examples; we could use other headings but likely they expect those. Safer to stick to those.
Thus we can put occupational demands under Requirements or maybe under Skills? Probably under Requirements as it's about job demands.
We need to preserve all substantive info: location, etc. Location could be part of About the role or maybe a separate short p.
We must not include duplicated lines. The posting repeats some sentences (e.g., "Under the direct supervision of the Quality Systems Manager, perform quality assurance and Training functions..." appears twice). We should deduplicate.
Let's extract substantive content:
Intro: "Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions."
Then role summary: "Quality Systems Associate Summary: Under the direct supervision of the Quality Systems Manager, perform quality assurance and Training functions to ensure compliance with internal and external regulations and protocol."
Then list of primary responsibilities (level-specific responsibilities should be included in chart below) but we have bullet list:
- Completes weekly review of equipment QC and maintenance records.
- Documents, investigates, and performs root-cause analysis for deviations and customer complaints, specifically in how they related to product quality and/or donor safety.
- Inspects and releases incoming supplies.
- Investigates and reports supplies have not met quality specifications and requirements prior to use.
- Performs documentation review for unsuitable test results.
- Assists the Quality Systems Manager to ensure that cGMP regulation, SOPs and regulatory requirements are followed.
- Performs all product release activities.
- Reviews lookback information and documentation.
- Reviews waste shipment documentation.
- Reviews unexpected plasmapheresis events including electronic donor chart and related documentation pertaining to exceptions occurring during the donation process.
- Reviews electronic donor chart exceptions impacting donor eligibility/safety and/or product quality.
- Reviews donor deferral notifications from competitor centers.
- Reviews plasma processing documentation to ensure the proper freezing, storage and handling of product.
- Quality Systems Associate Assist the Quality Systems Manager to ensure center training programs follow procedural requirements as defined in the donor center SOP and/or training programs documents.
- Creates, maintains, and audits training records and files to ensure compliance.
- Performs employee training observations to ensure staff competency prior to releasing employees to work independently.
- Conducts required training activities for Center Notifications, Corporate Directives, SOP changes, and initial SOP implementations.
- On an occasional basis, when the Quality Systems Manager is absent, the Quality Systems Associate may be required to perform the following duties:
- Reviews and approves of deferred donor reinstatement activities.
- Assists with completion of the internal donor center audit.
- Summary: Performs review of monthly trending report.
- Performs review of donor adverse events reports and the applicable related documentation.
- Conducts training to address donor center corrective and preventative measures.
Then "Additional Responsibilities: Is certified and maintains certification as a Donor Center Technician."
Then "Knowledge, Skills, And Abilities: Developing command of interpersonal communication, organizational and problem-solving skills. Ability to understand FDA regulations. Strong integrity and commitment to quality and compliance. Good knowledge of mathematics. Legible handwriting. Proficiency with computers. Ability to work flexible scheduling to meet business needs. Performs basic document review and employee observations. Communicates openly with the CQM on issues noted during reviews. Ability to understand and follow SOP’s and protocols. Ability to perform primary responsibilities of the Quality Associate role in a proficient manner. Has a basic understanding of cGMP and quality systems. Is able to spend hours sitting and reviewing documentation for accuracy. Demonstrates good organizational skills and attention to detail."
Then "Education: High school diploma or GED. Obtains state licensures or certifications if applicable."
Then "Experience: Typically requires no previous related experience."
Then Occupational Demands Form #70 details: list of physical demands, exposures, etc.
Then location: "Location: NORTH AMERICA : USA : TX-Channelview:USCHANNE - Channelview TX-Sheldon Rd-BPL"
Then "Learn more about Grifols" (boilerplate to remove).
We also have "#biomatusa" maybe ignore.
We need to output HTML fragment only.
Let's craft sections:
About the role
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Under the direct supervision of the Quality Systems Manager, perform quality assurance and training functions to ensure compliance with internal and external regulations and protocol.
That covers intro and summary.
Responsibilities
- Completes weekly review of equipment QC and maintenance records.
- Documents, investigates, and performs root-cause analysis for deviations and customer complaints, specifically as they relate to product quality and/or donor safety.
- Inspects and releases incoming supplies.
- Investigates and reports supplies that have not met quality specifications and requirements prior to use.
- Performs documentation review for unsuitable test results.
- Assists the Quality Systems Manager to ensure that cGMP regulations, SOPs and regulatory requirements are followed.
- Performs all product release activities.
- Reviews lookback information and documentation.
- Reviews waste shipment documentation.
- Reviews unexpected plasmapheresis events including electronic donor chart and related documentation pertaining to exceptions occurring during the donation process.
- Reviews electronic donor chart exceptions impacting donor eligibility, safety and/or product quality.
- Reviews donor deferral notifications from competitor centers.
- Reviews plasma processing documentation to ensure the proper freezing, storage and handling of product.
- Creates, maintains, and audits training records and files to ensure compliance.
- Performs employee training observations to ensure staff competency prior to releasing employees to work independently.
- Conducts required training activities for Center Notifications, Corporate Directives, SOP changes, and initial SOP implementations.
- On an occasional basis, when the Quality Systems Manager is absent, may be required to review and approve deferred donor reinstatement activities and assist with completion of the internal donor center audit.
- Performs review of monthly trending report.
- Performs review of donor adverse events reports and the applicable related documentation.
- Conducts training to address donor center corrective and preventative measures.
Note: we removed duplicate lines.
Requirements
- Certified and maintains certification as a Donor Center Technician.
- High school diploma or GED.
- Obtains state licensures or certifications if applicable.
- Typically requires no previous related experience.
- Developing command of interpersonal communication, organizational and problem‑solving skills.
- Ability to understand FDA regulations.
- Strong integrity and commitment to quality and compliance.
- Good knowledge of mathematics.
- Legible handwriting.
- Proficiency with computers.
- Ability to work flexible scheduling to meet business needs.
- Performs basic document review and employee observations.
- Communicates openly with the CQM on issues noted during reviews.
- Ability to understand and follow SOPs and protocols.
- Ability to perform primary responsibilities of the Quality Associate role in a proficient manner.
- Has a basic understanding of cGMP and quality systems.
- Is able to spend hours sitting and reviewing documentation for accuracy.
- Demonstrates good organizational skills and attention to detail.
But we separated knowledge/skills into Requirements; maybe better to have Skills section. However we have many items; we could split: Requirements (education, experience, certification) and Skills (knowledge, skills, abilities). Let's do that.
Thus:
Requirements
- Certified and maintains certification as a Donor Center Technician.
- High school diploma or GED.
- Obtains state licensures or certifications if applicable.
- Typically requires no previous related experience.
Skills
- Developing command of interpersonal communication, organizational and problem‑solving skills.
- Ability to understand FDA regulations.
- Strong integrity and commitment to quality and compliance.
- Good knowledge of mathematics.
- Legible handwriting.
- Proficiency with computers.
- Ability to work flexible scheduling to meet business needs.
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." The e.g. suggests those are examples; we could use other headings but likely they expect those. Safer to stick to those.
Thus we can put occupational demands under Requirements or maybe under Skills? Probably under Requirements as it's about job demands.
We need to preserve all substantive info: location, etc. Location could be part of About the role or maybe a separate short p.
We must not include duplicated lines. The posting repeats some sentences (e.g., "Under the direct supervision of the Quality Systems Manager, perform quality assurance and Training functions..." appears twice). We should deduplicate.
Let's extract substantive content:
Intro: "Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions."
Then role summary: "Quality Systems Associate Summary: Under the direct supervision of the Quality Systems Manager, perform quality assurance and Training functions to ensure compliance with internal and external regulations and protocol."
Then list of primary responsibilities (level-specific responsibilities should be included in chart below) but we have bullet list:
- Completes weekly review of equipment QC and maintenance records.
- Documents, investigates, and performs root-cause analysis for deviations and customer complaints, specifically in how they related to product quality and/or donor safety.
- Inspects and releases incoming supplies.
- Investigates and reports supplies have not met quality specifications and requirements prior to use.
- Performs documentation review for unsuitable test results.
- Assists the Quality Systems Manager to ensure that cGMP regulation, SOPs and regulatory requirements are followed.
- Performs all product release activities.
- Reviews lookback information and documentation.
- Reviews waste shipment documentation.
- Reviews unexpected plasmapheresis events including electronic donor chart and related documentation pertaining to exceptions occurring during the donation process.
- Reviews electronic donor chart exceptions impacting donor eligibility/safety and/or product quality.
- Reviews donor deferral notifications from competitor centers.
- Reviews plasma processing documentation to ensure the proper freezing, storage and handling of product.
- Quality Systems Associate Assist the Quality Systems Manager to ensure center training programs follow procedural requirements as defined in the donor center SOP and/or training programs documents.
- Creates, maintains, and audits training records and files to ensure compliance.
- Performs employee training observations to ensure staff competency prior to releasing employees to work independently.
- Conducts required training activities for Center Notifications, Corporate Directives, SOP changes, and initial SOP implementations.
- On an occasional basis, when the Quality Systems Manager is absent, the Quality Systems Associate may be required to perform the following duties:
- Reviews and approves of deferred donor reinstatement activities.
- Assists with completion of the internal donor center audit.
- Summary: Performs review of monthly trending report.
- Performs review of donor adverse events reports and the applicable related documentation.
- Conducts training to address donor center corrective and preventative measures.
Then "Additional Responsibilities: Is certified and maintains certification as a Donor Center Technician."
Then "Knowledge, Skills, And Abilities: Developing command of interpersonal communication, organizational and problem-solving skills. Ability to understand FDA regulations. Strong integrity and commitment to quality and compliance. Good knowledge of mathematics. Legible handwriting. Proficiency with computers. Ability to work flexible scheduling to meet business needs. Performs basic document review and employee observations. Communicates openly with the CQM on issues noted during reviews. Ability to understand and follow SOP’s and protocols. Ability to perform primary responsibilities of the Quality Associate role in a proficient manner. Has a basic understanding of cGMP and quality systems. Is able to spend hours sitting and reviewing documentation for accuracy. Demonstrates good organizational skills and attention to detail."
Then "Education: High school diploma or GED. Obtains state licensures or certifications if applicable."
Then "Experience: Typically requires no previous related experience."
Then Occupational Demands Form #70 details: list of physical demands, exposures, etc.
Then location: "Location: NORTH AMERICA : USA : TX-Channelview:USCHANNE - Channelview TX-Sheldon Rd-BPL"
Then "Learn more about Grifols" (boilerplate to remove).
We also have "#biomatusa" maybe ignore.
We need to output HTML fragment only.
Let's craft sections:
About the role
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Under the direct supervision of the Quality Systems Manager, perform quality assurance and training functions to ensure compliance with internal and external regulations and protocol.
That covers intro and summary.Responsibilities
- Completes weekly review of equipment QC and maintenance records.
- Documents, investigates, and performs root-cause analysis for deviations and customer complaints, specifically as they relate to product quality and/or donor safety.
- Inspects and releases incoming supplies.
- Investigates and reports supplies that have not met quality specifications and requirements prior to use.
- Performs documentation review for unsuitable test results.
- Assists the Quality Systems Manager to ensure that cGMP regulations, SOPs and regulatory requirements are followed.
- Performs all product release activities.
- Reviews lookback information and documentation.
- Reviews waste shipment documentation.
- Reviews unexpected plasmapheresis events including electronic donor chart and related documentation pertaining to exceptions occurring during the donation process.
- Reviews electronic donor chart exceptions impacting donor eligibility, safety and/or product quality.
- Reviews donor deferral notifications from competitor centers.
- Reviews plasma processing documentation to ensure the proper freezing, storage and handling of product.
- Creates, maintains, and audits training records and files to ensure compliance.
- Performs employee training observations to ensure staff competency prior to releasing employees to work independently.
- Conducts required training activities for Center Notifications, Corporate Directives, SOP changes, and initial SOP implementations.
- On an occasional basis, when the Quality Systems Manager is absent, may be required to review and approve deferred donor reinstatement activities and assist with completion of the internal donor center audit.
- Performs review of monthly trending report.
- Performs review of donor adverse events reports and the applicable related documentation.
- Conducts training to address donor center corrective and preventative measures.
Requirements
- Certified and maintains certification as a Donor Center Technician.
- High school diploma or GED.
- Obtains state licensures or certifications if applicable.
- Typically requires no previous related experience.
- Developing command of interpersonal communication, organizational and problem‑solving skills.
- Ability to understand FDA regulations.
- Strong integrity and commitment to quality and compliance.
- Good knowledge of mathematics.
- Legible handwriting.
- Proficiency with computers.
- Ability to work flexible scheduling to meet business needs.
- Performs basic document review and employee observations.
- Communicates openly with the CQM on issues noted during reviews.
- Ability to understand and follow SOPs and protocols.
- Ability to perform primary responsibilities of the Quality Associate role in a proficient manner.
- Has a basic understanding of cGMP and quality systems.
- Is able to spend hours sitting and reviewing documentation for accuracy.
- Demonstrates good organizational skills and attention to detail.
Requirements
- Certified and maintains certification as a Donor Center Technician.
- High school diploma or GED.
- Obtains state licensures or certifications if applicable.
- Typically requires no previous related experience.
Skills
- Developing command of interpersonal communication, organizational and problem‑solving skills.
- Ability to understand FDA regulations.
- Strong integrity and commitment to quality and compliance.
- Good knowledge of mathematics.
- Legible handwriting.
- Proficiency with computers.
- Ability to work flexible scheduling to meet business needs.