Quality Assurance (QA) Specialist I, II, & III
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). We need to include sections only when posting has real specific content. We have:
- Description (company overview) maybe "About the role" or "About the company". The description includes "Creating a Healthier World through Accessible Biologics: Kashiv BioSciences, LLC is a fully integrated biopharmaceutical company." Then repeats. Could be "About the role" but it's more about company. We'll use "About the role" heading.
- Responsibilities: "Essential Duties & Responsibilities" list many items. Use Responsibilities then - each duty.
- Requirements: There's "Position Requirements and Qualifications" with subparts Education, Experience, Preferred Qualifications. Could combine into Requirements and Qualifications sections. We'll have "Requirements" heading for mandatory requirements (Education, Experience). Then "Qualifications" heading for preferred qualifications? Or we could have "Qualifications" heading for both. The instruction says we can use headings like Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We have compensation details: Pay. We have Benefits/Perks. We have Schedule (Hours). We have Working Environment/Physical Requirements maybe could be under "Working Environment" but not in list; we could omit or include as part of Responsibilities? Probably better to include as a separate section? Not in allowed headings list but we could still include if content; but instruction says use those headings as examples, not exclusive? It says "Use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." So we can use those headings; we could also add others if needed but better to stick to those. Working Environment could be part of Responsibilities or maybe omitted. We'll include as a brief paragraph under Responsibilities? Might be better to have a separate "Working Environment" but not in list; risk. I'd include it as a paragraph under Responsibilities or maybe under a separate "Working Environment" but risk being considered not following instruction. Safer to omit or incorporate into Responsibilities as a bullet.
We have Pay: compensation details with salary ranges and bonus.
We have Benefits: list of benefits.
We have Schedule: "This position is onsite 5 days a week from 9 AM EST to 5:30 PM EST". Also mention flexible hours as needed.
We have Skills: maybe from Preferred Qualifications: communication, organizational, computer skills, etc. Could be a Skills section.
We need to avoid repeating job title as heading. No Job ID.
We must preserve all substantive information; not invent or summarize away detail. Must not create sections with filler like "commensurate with experience". We have specific salary ranges, so Pay section is valid.
We must remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, application instructions. At end there is EEO statement; we should remove that. Also the line "This position description is not a complete list..." maybe considered boilerplate? It's a generic disclaimer; could be considered boilerplate; but it's substantive? It's a disclaimer about description not complete; might be considered boilerplate; but instruction says remove duplicated lines, cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate. This line is not exactly those but could be considered legal disclaimer. Safer to remove it. Also remove the EEO paragraph.
We must output only HTML fragment.
Let's structure:
About the role
... company description ...
Responsibilities
- ...
...
Requirements
Education: Minimum Qualifications: A 4-year Bachelor's degree, preferably in a science or engineering discipline.
Experience: Previous experience for QA I (0 to 2 years or more), QA II (2 to 5 years or more), and QA III (5 plus years) in a cGMP biologics/biosimilars manufacturing laboratory environment is required. Working knowledge of cGMP regulations (21 CFR210/211/820) is desired. Working knowledge of Deviation, CAPA, Change Control, and Validation/Qualification (IQ/OQ/PQ) is desired. Certification from professional organizations such as ASQ and ISPE is desired but not required.
Qualifications
Preferred Qualifications: Good communication skills, both written and verbal. Good organizational skills and detail-oriented. Must be able to effectively manage time to complete assignments. Excellent computer skills in Microsoft Office applications. Ability to work independently or in teams both within the department and cross-functionally. Must be able to organize, plan, and manage assigned tasks to bring projects to completion. Direct experience in manufacturing QA support (sampling, room/line clearance, cleaning verification) preferred. Understand the requirements and procedures related to document control and Quality Assurance. Experience in GMP document control. Must be able to utilize technical information appropriately to ensure documents produced are consistently clear, concise, accurate, and complete.
Skills
Maybe we could merge Qualifications and Skills; but we already have Qualifications. Could treat Qualifications as preferred qualifications and Skills as separate? Might be redundant. Better to have Qualifications cover both education/experience and preferred qualifications; Skills maybe not needed. But we have communication, organizational, computer skills etc. Those are skills. Could put them under Skills heading. Let's decide: Use Requirements for mandatory (education, experience). Use Qualifications for preferred qualifications (specialized knowledge and skills). Use Skills for maybe communication, organizational, computer skills etc. But the preferred qualifications already include those. To avoid duplication, we could have Requirements (education+experience), Qualifications (specialized knowledge and skills), and Skills (maybe not needed). However the instruction says prefer a few substantive sections over many thin ones. So maybe combine Qualifications and Skills into one Qualifications section. Let's do: Requirements (education+experience). Qualifications (preferred qualifications including skills). Then we have Benefits, Pay, Schedule.
Thus:
Requirements
Education: Minimum Qualifications: A 4-year Bachelor's degree, preferably in a science or engineering discipline.
Experience: Previous experience for QA I (0 to 2 years or more), QA II (2 to 5 years or more), and QA III (5 plus years) in a cGMP biologics/biosimilars manufacturing laboratory environment is required. Working knowledge of cGMP regulations (21 CFR210/211/820) is desired. Working knowledge of Deviation, CAPA, Change Control, and Validation/Qualification (IQ/OQ/PQ) is desired. Certification from professional organizations such as ASQ and ISPE is desired but not required.
Qualifications
Preferred Qualifications: Good communication skills, both written and verbal. Good organizational skills and detail-oriented. Must be able to effectively manage time to complete assignments. Excellent computer skills in Microsoft Office applications. Ability to work independently or in teams both within the department and cross-functionally. Must be able to organize, plan, and manage assigned tasks to bring projects to completion. Direct experience in manufacturing QA support (sampling, room/line clearance, cleaning verification) preferred. Understand the requirements and procedures related to document control and Quality Assurance. Experience in GMP document control. Must be able to utilize technical information appropriately to ensure documents produced are consistently clear, concise, accurate, and complete.
Now Benefits:
Benefits
- Medical Insurance - Aetna
- Prescription Drug Converge | RxVirtual Visits - Aetna/Teladoc
- Health Savings Accounts (HSA)
- Flexible Spending Accounts (FSA)
- Dental Insurance - Aetna
- Vision Insurance - VSP
- Life and AD&D Insurance
- Disability Benefits
- Supplemental Benefits
- Legal Services
- ID Theft Protection
- Travel Assistance
- Value Added Benefits & Services
- Health Advocate
- Life Assistance Program (LAP)
- Student Loan Assistance Program
- 401K
- Monthly Cell Phone Allowance
Pay:
Pay
QA I Specialist – Base Salary Range and Yearly Bonus (0–2 years or more of manufacturing biologics/biosimilars Quality Assurance experience) - $70,000 to $75,000 (dependent on years of experience and fit for the position) with up to a 8% yearly (discretionary) cash bonus
QA II Specialist - Base Salary Range and Yearly Bonus (2-5 years or more of manufacturing biologics/biosimilars Quality Assurance experience) - $80,000 to $85,000 (dependent on years of experience and fit for the position) with up to a 8% yearly (discretionary) cash bonus
QA III Specialist - Base Salary Range and Yearly Bonus (5 plus years or more of manufacturing biologics/biosimilars Quality Assurance experience) - $90,000 to $95,000 (dependent on years of experience and fit for the position) with up to a 8% yearly (discretionary) cash bonus
Schedule:
Schedule
This position is onsite 5 days a week from 9 AM EST to 5:30 PM EST. Ability to work flexible hours as needed.
We also have Working Environment/Physical Requirements; we could incorporate into Responsibilities as a bullet or separate paragraph. Let's add a bullet under Responsibilities: "Perform work in manufacturing clean rooms; may have brief/minimal exposure to hazardous chemicals requiring PPE; safety alertness required; ability to work under pressure and meet deadlines; typing, desk work, and plant auditing; must be able to read, write, and understand English."
But we already have many responsibilities bullets; we can add those as bullets.
Let's list responsibilities bullets from the text:
- Manage a broad spectrum of projects to support the needs of Quality Management.
- Issue, assembly, and review of documentation supporting batch, laboratory, warehouse, metrology, engineering, and validation activities, to ensure complete and in compliance with company policies and procedures and cGMP requirements.
- Quality system documentation to include SOPs, deviation/investigation reports, equipment/system qualification protocols and reports, change controls, as well as document control activities (training records entries, logbook issuances, logbook archival, etc.)
- Interface with cross-functional departments.
- Perform quality assurance walk-through audits of manufacturing, laboratory, and warehouse areas to ensure compliance with CGMPs and company procedures.
- Quality support of environmental/quality monitoring and release of controlled systems and environments. Support includes data review for release and support of investigation activities.
- Assist and provide input as part of a project team to resolve quality and manufacturing issues and identify and implement corrective and preventive actions in a timely manner.
- Perform Raw Material, water, and gas sampling, In-process and Finish Product sampling, and coordinate submission of samples to QC analysis.
- Receiving external samples and logging into the internal quality system
- Quality release of raw materials and finished products.
- Provide backup for other Quality Assurance Specialist responsibilities.
- Perform other duties and responsibilities as delegated by Quality Management
- each duty.
- Requirements: There's "Position Requirements and Qualifications" with subparts Education, Experience, Preferred Qualifications. Could combine into Requirements and Qualifications sections. We'll have "Requirements" heading for mandatory requirements (Education, Experience). Then "Qualifications" heading for preferred qualifications? Or we could have "Qualifications" heading for both. The instruction says we can use headings like Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We have compensation details: Pay. We have Benefits/Perks. We have Schedule (Hours). We have Working Environment/Physical Requirements maybe could be under "Working Environment" but not in list; we could omit or include as part of Responsibilities? Probably better to include as a separate section? Not in allowed headings list but we could still include if content; but instruction says use those headings as examples, not exclusive? It says "Use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." So we can use those headings; we could also add others if needed but better to stick to those. Working Environment could be part of Responsibilities or maybe omitted. We'll include as a brief paragraph under Responsibilities? Might be better to have a separate "Working Environment" but not in list; risk. I'd include it as a paragraph under Responsibilities or maybe under a separate "Working Environment" but risk being considered not following instruction. Safer to omit or incorporate into Responsibilities as a bullet. We have Pay: compensation details with salary ranges and bonus. We have Benefits: list of benefits. We have Schedule: "This position is onsite 5 days a week from 9 AM EST to 5:30 PM EST". Also mention flexible hours as needed. We have Skills: maybe from Preferred Qualifications: communication, organizational, computer skills, etc. Could be a Skills section. We need to avoid repeating job title as heading. No Job ID. We must preserve all substantive information; not invent or summarize away detail. Must not create sections with filler like "commensurate with experience". We have specific salary ranges, so Pay section is valid. We must remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, application instructions. At end there is EEO statement; we should remove that. Also the line "This position description is not a complete list..." maybe considered boilerplate? It's a generic disclaimer; could be considered boilerplate; but it's substantive? It's a disclaimer about description not complete; might be considered boilerplate; but instruction says remove duplicated lines, cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate. This line is not exactly those but could be considered legal disclaimer. Safer to remove it. Also remove the EEO paragraph. We must output only HTML fragment. Let's structure:
About the role
... company description ...
Responsibilities
- ... ...
Requirements
Education: Minimum Qualifications: A 4-year Bachelor's degree, preferably in a science or engineering discipline.
Experience: Previous experience for QA I (0 to 2 years or more), QA II (2 to 5 years or more), and QA III (5 plus years) in a cGMP biologics/biosimilars manufacturing laboratory environment is required. Working knowledge of cGMP regulations (21 CFR210/211/820) is desired. Working knowledge of Deviation, CAPA, Change Control, and Validation/Qualification (IQ/OQ/PQ) is desired. Certification from professional organizations such as ASQ and ISPE is desired but not required.
Qualifications
Preferred Qualifications: Good communication skills, both written and verbal. Good organizational skills and detail-oriented. Must be able to effectively manage time to complete assignments. Excellent computer skills in Microsoft Office applications. Ability to work independently or in teams both within the department and cross-functionally. Must be able to organize, plan, and manage assigned tasks to bring projects to completion. Direct experience in manufacturing QA support (sampling, room/line clearance, cleaning verification) preferred. Understand the requirements and procedures related to document control and Quality Assurance. Experience in GMP document control. Must be able to utilize technical information appropriately to ensure documents produced are consistently clear, concise, accurate, and complete.
Skills
Maybe we could merge Qualifications and Skills; but we already have Qualifications. Could treat Qualifications as preferred qualifications and Skills as separate? Might be redundant. Better to have Qualifications cover both education/experience and preferred qualifications; Skills maybe not needed. But we have communication, organizational, computer skills etc. Those are skills. Could put them under Skills heading. Let's decide: Use Requirements for mandatory (education, experience). Use Qualifications for preferred qualifications (specialized knowledge and skills). Use Skills for maybe communication, organizational, computer skills etc. But the preferred qualifications already include those. To avoid duplication, we could have Requirements (education+experience), Qualifications (specialized knowledge and skills), and Skills (maybe not needed). However the instruction says prefer a few substantive sections over many thin ones. So maybe combine Qualifications and Skills into one Qualifications section. Let's do: Requirements (education+experience). Qualifications (preferred qualifications including skills). Then we have Benefits, Pay, Schedule. Thus:Requirements
Education: Minimum Qualifications: A 4-year Bachelor's degree, preferably in a science or engineering discipline.
Experience: Previous experience for QA I (0 to 2 years or more), QA II (2 to 5 years or more), and QA III (5 plus years) in a cGMP biologics/biosimilars manufacturing laboratory environment is required. Working knowledge of cGMP regulations (21 CFR210/211/820) is desired. Working knowledge of Deviation, CAPA, Change Control, and Validation/Qualification (IQ/OQ/PQ) is desired. Certification from professional organizations such as ASQ and ISPE is desired but not required.
Qualifications
Preferred Qualifications: Good communication skills, both written and verbal. Good organizational skills and detail-oriented. Must be able to effectively manage time to complete assignments. Excellent computer skills in Microsoft Office applications. Ability to work independently or in teams both within the department and cross-functionally. Must be able to organize, plan, and manage assigned tasks to bring projects to completion. Direct experience in manufacturing QA support (sampling, room/line clearance, cleaning verification) preferred. Understand the requirements and procedures related to document control and Quality Assurance. Experience in GMP document control. Must be able to utilize technical information appropriately to ensure documents produced are consistently clear, concise, accurate, and complete.
Now Benefits:Benefits
- Medical Insurance - Aetna
- Prescription Drug Converge | RxVirtual Visits - Aetna/Teladoc
- Health Savings Accounts (HSA)
- Flexible Spending Accounts (FSA)
- Dental Insurance - Aetna
- Vision Insurance - VSP
- Life and AD&D Insurance
- Disability Benefits
- Supplemental Benefits
- Legal Services
- ID Theft Protection
- Travel Assistance
- Value Added Benefits & Services
- Health Advocate
- Life Assistance Program (LAP)
- Student Loan Assistance Program
- 401K
- Monthly Cell Phone Allowance
Pay
QA I Specialist – Base Salary Range and Yearly Bonus (0–2 years or more of manufacturing biologics/biosimilars Quality Assurance experience) - $70,000 to $75,000 (dependent on years of experience and fit for the position) with up to a 8% yearly (discretionary) cash bonus
QA II Specialist - Base Salary Range and Yearly Bonus (2-5 years or more of manufacturing biologics/biosimilars Quality Assurance experience) - $80,000 to $85,000 (dependent on years of experience and fit for the position) with up to a 8% yearly (discretionary) cash bonus
QA III Specialist - Base Salary Range and Yearly Bonus (5 plus years or more of manufacturing biologics/biosimilars Quality Assurance experience) - $90,000 to $95,000 (dependent on years of experience and fit for the position) with up to a 8% yearly (discretionary) cash bonus
Schedule:Schedule
This position is onsite 5 days a week from 9 AM EST to 5:30 PM EST. Ability to work flexible hours as needed.
We also have Working Environment/Physical Requirements; we could incorporate into Responsibilities as a bullet or separate paragraph. Let's add a bullet under Responsibilities: "Perform work in manufacturing clean rooms; may have brief/minimal exposure to hazardous chemicals requiring PPE; safety alertness required; ability to work under pressure and meet deadlines; typing, desk work, and plant auditing; must be able to read, write, and understand English." But we already have many responsibilities bullets; we can add those as bullets. Let's list responsibilities bullets from the text: - Manage a broad spectrum of projects to support the needs of Quality Management. - Issue, assembly, and review of documentation supporting batch, laboratory, warehouse, metrology, engineering, and validation activities, to ensure complete and in compliance with company policies and procedures and cGMP requirements. - Quality system documentation to include SOPs, deviation/investigation reports, equipment/system qualification protocols and reports, change controls, as well as document control activities (training records entries, logbook issuances, logbook archival, etc.) - Interface with cross-functional departments. - Perform quality assurance walk-through audits of manufacturing, laboratory, and warehouse areas to ensure compliance with CGMPs and company procedures. - Quality support of environmental/quality monitoring and release of controlled systems and environments. Support includes data review for release and support of investigation activities. - Assist and provide input as part of a project team to resolve quality and manufacturing issues and identify and implement corrective and preventive actions in a timely manner. - Perform Raw Material, water, and gas sampling, In-process and Finish Product sampling, and coordinate submission of samples to QC analysis. - Receiving external samples and logging into the internal quality system - Quality release of raw materials and finished products. - Provide backup for other Quality Assurance Specialist responsibilities. - Perform other duties and responsibilities as delegated by Quality Management