Company
Biotech
QualityComplianceAssociateI/II
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Quality Compliance Associate I/II. Skills: Internal audits, Supplier audits, Audit reporting. Plan internal audits of GxP processes. Execute internal audits of GxP processes”
Industry & Context.
Risk-based auditing; Root cause analysis; CAPA effectiveness verification; Gap assessment; Propose improvements
What They're Looking For.
Must Have
Bachelor's degree in scientific or technical field or equivalent experience, 1-2 years auditing experience, Working knowledge of FDA 21 CFR Parts 210/211, Working knowledge of ICH Q-series, Working knowledge of EU GMP, Working knowledge of GDP principles, Experience performing audits against quality system elements, Technical writing skills, Proficiency with risk-based auditing, Proficiency with root cause analysis, Proficiency with CAPA effectiveness verification, Excellent communication skills, Excellent stakeholder management skills
Nice to Have
Certified Quality Auditor (CQA) – ASQ, or equivalent certification, Experience auditing CMOs/CDMOs, Experience auditing complex supply chains, Background with data integrity assessments, Background with CSV assessments, Background with Annex 11 assessments, Background with Part 11 assessments, Exposure to biologics, Exposure to cell & gene therapy, Exposure to aseptic processing, Exposure to sterile manufacturing, Knowledge of ISO 9001/13485, Knowledge of 21 CFR 210/211, Knowledge of pharmacovigilance quality systems
What You'll Do.
Plan internal audits of GxP processes
Execute internal audits of GxP processes
Report on internal audits of GxP processes
Support supplier audits
Monitor ongoing supplier performance
Prepare detailed audit agendas
Prepare sampling strategies
Track CAPA effectiveness
Verify CAPA effectiveness
Drive timely CAPA closure
Support inspection readiness activities
Host regulatory inspections
Liaise during regulatory inspections
Perform gap assessments against current regulations
Propose reasonable improvements
Collaborate with QA/QC
Collaborate with Manufacturing
Collaborate with Regulatory
Collaborate with Supply Chain
Maintain audit schedules
Maintain audit metrics
Communicate status to stakeholders
Communicate status to management
Contribute to policy development
Contribute to SOP development
Contribute to continuous improvement initiatives
How You'll Work.
Team & Collaboration
Collaborate with QA/QC; Collaborate with Manufacturing; Collaborate with Regulatory; Collaborate with Supply Chain; Collaborate with IT; Communicate status to stakeholders; Communicate status to management
Communication Scope
Technical writing; Audit reports; Stakeholder communication
Full Job Description
## Key Responsibilities Plan, execute, and report on internal audits of GxP processes (e.g., GMP manufacturing, QC, validation, laboratories, supply chain). Lead or support supplier/vendor audits and monitor ongoing supplier performance. Prepare detailed audit agendas, checklists, and sampling strategies aligned with risk and compliance priorities. Document findings clearly; issue audit reports with classifications, evidence, and actionable recommendations. Track and verify effectiveness of CAPAs (Corrective and Preventive Actions) and drive timely closure. Support inspection readiness activities and host/liaise during regulatory inspections (e.g., FDA, EMA, MHRA). Perform gap assessments against current regulations and industry standards; propose reasonable improvements. Collaborate with QA/QC, Manufacturing, Regulatory, Supply Chain, and IT to strengthen quality systems. Maintain audit schedules, metrics, and dashboards; communicate status to stakeholders and management. Contribute to policy/SOP development, training, and continuous improvement initiatives. ## Minimum Qualifications Bachelor's degree in a scientific or technical field (e.g., Chemistry, Biology, Engineering) or equivalent experience. 1-2 years of auditing experience within biopharma, biotech, medical devices, or related regulated industry. Working knowledge of FDA 21 CFR Parts 210/211, ICH Q-series, EU GMP, and GDP principles. Experience performing audits against quality system elements (Deviation, CAPA, Change Control, Training, Document Control). Strong technical writing skills and attention to detail; able to produce clear, evidence-based audit reports. Proficiency with risk-based auditing, root cause analysis, and CAPA effectiveness verification. Excellent communication and stakeholder management skills; comfortable engaging at all levels. ## Preferred Qualifications Certified Quality Auditor (CQA) – ASQ, or equivalent certification. Experience auditing CMOs/CDMOs and complex supply chains. Bac
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