• Reviews and approves analytical method qualification protocols, reports, test methods, and related QC/Analytical Development documentation.
• Performs QA review and approval of equipment onboarding and qualification records (URS, IQ, OQ, PQ, maintenance).
• Reviews incoming raw material documentation and supports QA disposition activities.
• Supports deviations, OOS/OOT investigations, and cross‑functional root cause analyses.
• Provides on‑the‑floor QA support during GMP manufacturing operations and real‑time issue escalation.
• Reviews and approves GMP documents (e.g., master and executed batch records, SOPs) for accuracy, completeness, and compliance.
• Contributes to Quality System records (Deviations, CAPAs, Change Controls, Laboratory Investigations) as a reviewer or investigator.
• Collaborates with Manufacturing, QC, Analytical Development, and Engineering to support compliant and efficient GMP operations.
• Adheres to internal procedures and applicable GMP regulatory requirements.
• Contributes to site quality initiatives, operational efficiency projects, and activities related to technology transfer and commercialization.
• Assists other Quality groups as needed, including document control, training, and audits.
• Communicates effectively with supervisors, colleagues, and teams.
• Adheres to regulatory and Abzena quality standards, policies, procedures, and mission.
• Maintain the highest ethical and moral standards

• Bachelor's degree in science or engineering or equivalent with 5-8 years of relevant experience in the Pharmaceutical, Biologic, Biotechnology, or Medical Device space.
• Relevant experience as in Quality Assurance, Quality Systems, Quality Compliance, Quality Control, GMP manufacturing and testing.
• Experienced in leading Root Cause Analysis investigations, developing corrective actions, and performing risk assessments.
• Experienced in early-phase to commercial quality systems development and maintenance.
• Adequate knowledge of industry standards and regulation requirements for biologics and small molecules in clinical development and commercial.
• Adequate knowledge of GMP regulations (e.g. US, EU, and ROW), good documentation practices, cGMP, 21CFR Part 210 and 211, USP and other applicable regulations, standards, and guidance.

• Ability to stand for 1-2 hours at a time, sit for 2 to 3 hours at a time.
• Require working in an office setting where sitting and computer usage would be the norm

#IND-SPG



Estimated Min Rate : $31.50

Estimated Max Rate : $45.00

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• MetLife Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly epayroll
• Referral Bonus Programs
• Certification and training opportunities

Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.