QA Compliance Specialist
Lonza, Portsmouth, NH, United States
QA Compliance Specialist
United States, Portsmouth (New Hampshire)
Location:
This position is based in our Portsmouth, NH office. The typical work schedule is Monday through Friday, 8:00 AM–5:00 PM EST.
What you will get
Performance-related bonus.
Medical, dental and vision insurance.
401(k) matching plan.
Life insurance, as well as short-term and long-term disability insurance.
Employee assistance programs.
Paid time off (PTO).
Compensation determined by candidate’s qualifications, skills, experience, and relevant knowledge.
What you will do
Leverage knowledge to support the Cell Therapy (CT) Quality Management System (QMS) and drive compliance.
Act as a change agent—driving compliance, promoting inspection readiness, and supporting key review boards—while contributing to continuous improvement initiatives.
Support and continuously improve the CT QMS to ensure compliance with applicable regulations and internal standards.
Serve as a compliance champion by promoting inspection readiness, modeling quality behaviors, and supporting cross‑functional review boards (e.g., DRB, CAPA Review Board, Change Control Board).
Independently review and approve controlled documents within the Document Management System (DMS), including SOPs, work instructions, forms, and validation/qualification protocols and reports.
Ensure all documentation changes are accurate, justified, and compliant with established procedures; collaborate to resolve complex issues.
Participate in deviation investigations and the CAPA lifecycle, supporting root cause analysis and ensuring effective corrective and preventive actions.
Partner with subject matter experts to identify and close gaps in procedures, processes, and policies to maintain compliance with regulatory requirements (e.g., Annex 1, CFRs).
Monitor and support key quality metrics (KPIs/KQIs), identify trends, and drive continuous improvement.
Build strong cross‑functional relationships with Manufacturing, MSAT, QC, and other teams to foster a strong quality culture.
Provide guidance and coaching on GMP principles to promote compliance and operational excellence.
Manage multiple priorities effectively in a dynamic, fast‑paced environment.
What we are looking for
Bachelor’s degree in Life Sciences, Chemistry, Biology, or a related field.
Working knowledge of GMP regulations and guidelines (e.g., ICH Q7–Q11, 21 CFR Parts 210, 211, 600–680, 820).
Strong written and verbal communication skills, engaging stakeholders at all levels.
Experience with quality and enterprise systems such as DMS, TrackWise, SAP, Syncade, or similar platforms.
Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint).
High attention to detail with strong organizational, analytical, and problem‑solving skills.
Self‑motivated and adaptable, managing changing priorities and workload effectively.
Ability to work independently and collaboratively within a team environment.
Sound judgment with clear presentation of solutions and appropriate escalation.
Experience in a regulated environment; cell therapy or biologics experience is a plus.
We are an equal opportunity employer. Lonza offers equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law.
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Location:
This position is based in our Portsmouth, NH office. The typical work schedule is Monday through Friday, 8:00 AM–5:00 PM EST.
What you will get
Performance-related bonus.
Medical, dental and vision insurance.
401(k) matching plan.
Life insurance, as well as short-term and long-term disability insurance.
Employee assistance programs.
Paid time off (PTO).
Compensation determined by candidate’s qualifications, skills, experience, and relevant knowledge.
What you will do
Leverage knowledge to support the Cell Therapy (CT) Quality Management System (QMS) and drive compliance.
Act as a change agent—driving compliance, promoting inspection readiness, and supporting key review boards—while contributing to continuous improvement initiatives.
Support and continuously improve the CT QMS to ensure compliance with applicable regulations and internal standards.
Serve as a compliance champion by promoting inspection readiness, modeling quality behaviors, and supporting cross‑functional review boards (e.g., DRB, CAPA Review Board, Change Control Board).
Independently review and approve controlled documents within the Document Management System (DMS), including SOPs, work instructions, forms, and validation/qualification protocols and reports.
Ensure all documentation changes are accurate, justified, and compliant with established procedures; collaborate to resolve complex issues.
Participate in deviation investigations and the CAPA lifecycle, supporting root cause analysis and ensuring effective corrective and preventive actions.
Partner with subject matter experts to identify and close gaps in procedures, processes, and policies to maintain compliance with regulatory requirements (e.g., Annex 1, CFRs).
Monitor and support key quality metrics (KPIs/KQIs), identify trends, and drive continuous improvement.
Build strong cross‑functional relationships with Manufacturing, MSAT, QC, and other teams to foster a strong quality culture.
Provide guidance and coaching on GMP principles to promote compliance and operational excellence.
Manage multiple priorities effectively in a dynamic, fast‑paced environment.
What we are looking for
Bachelor’s degree in Life Sciences, Chemistry, Biology, or a related field.
Working knowledge of GMP regulations and guidelines (e.g., ICH Q7–Q11, 21 CFR Parts 210, 211, 600–680, 820).
Strong written and verbal communication skills, engaging stakeholders at all levels.
Experience with quality and enterprise systems such as DMS, TrackWise, SAP, Syncade, or similar platforms.
Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint).
High attention to detail with strong organizational, analytical, and problem‑solving skills.
Self‑motivated and adaptable, managing changing priorities and workload effectively.
Ability to work independently and collaboratively within a team environment.
Sound judgment with clear presentation of solutions and appropriate escalation.
Experience in a regulated environment; cell therapy or biologics experience is a plus.
We are an equal opportunity employer. Lonza offers equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law.
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