The Associate I, Quality Operations provides day‑to‑day QA oversight and documentation review to support GMP manufacturing of intermediates and drug substances. The role ensures production activities are executed in compliance with cGMP requirements through on‑floor QA presence, batch record review, and support of batch disposition. The position works closely with Manufacturing, QC, and other Quality functions to identify, escalate, and resolve issues in real time.
Responsibilities
- Provide on‑floor QA support during GMP manufacturing to ensure compliance with procedures and cGMP standards.
- Participate in the QA walkthrough program to identify potential gaps/issues in the GMP facility.
- Escalate quality issues promptly and support real‑time troubleshooting.
- Support batch disposition through compilation of required documentation.
- Review batch records, logbooks, and GMP documentation for completeness and.
- Review incoming material disposition packets and verify documentation completeness.
- Perform QA review of SOPs, forms, protocols, and other controlled documents.
- Contribute to quality improvement, lean initiatives, and process efficiency projects.
- Assist across Quality functions including document control, training, audits, and systems.
- Communicate effectively with cross‑functional teams and uphold company quality standards and policies.
Qualifications
- Bachelor’s degree in science or engineering, or equivalent experience.
- 0-3+ years of relevant experience in a GMP‑regulated biopharmaceutical environment.
- Working knowledge of GMP regulations (US, EU, ROW), GDP, 21 CFR, USP, and applicable standards.
- Strong attention to detail and effective written and verbal communication skills.
- Ability to work independently and cross functionally on common goals.
Physical Requirements
- Ability to stand for 1-2 hours at a time, sit for 2 to 3 hours at a time.
- Frequently lift and or move objects up to 30 pounds.
- Visual abilities including near and far sight, color, peripheral vision, depth and ability to focus.
FLSA: Non-Exempt
Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.