Quality Assurance Associate Job for FreshersÂ
PCI Pharma Services is seeking a motivated Quality Associate I – Operations to support GMP manufacturing through real-time quality oversight, documentation review, and compliance monitoring. This Quality Assurance Associate Role is ideal for early-career professionals passionate about pharmaceutical quality, continuous improvement, and ensuring patient safety. With hands-on training, cross-functional collaboration, and opportunities for professional growth, this position offers a strong foundation for anyone seeking a Life Science career in pharmaceutical quality operations.
Job Details:
- Job Title: QA Associate I – Operations
- Company: PCI Pharma Services
- Location: Madison, Wisconsin
- Job Type: Full-time
- Department: Quality Assurance – Operations
About the Company:
PCI Pharma Services is a leading global CDMO supporting thousands of biopharma companies with drug development, clinical trial support, packaging, and manufacturing. With a mission rooted in innovation and service excellence, PCI focuses on creating life-changing therapies for patients worldwide by providing jobs for candidates that enhance their Life Science Career. Their commitment to people, progress, and global impact drives a strong culture of quality, collaboration, and continuous improvement.
Educational Requirements for Quality Assurance Associate Role:
- Bachelor’s degree in a scientific field (preferred).
- 0–2 years of experience in pharma/biotech.
- 1+ years in QA Operations preferred (not mandatory).
Key Responsibilities of Quality Assurance Associate Role:
- In this Biotech Job, you have to provide real-time QA support on the production floor during GMP operations.
- Audit manufacturing procedures and monitor compliance.
- Perform in-process batch record reviews for accuracy and completeness.
- Support lot disposition for intermediates and finished products.
- Conduct AQL visual inspections for drug product quality.
- In this QA Role, you will act as a first responder to quality issues, documenting investigations and assisting with corrective actions.
- Support deviations, root cause investigations, and CAPA processes (5 Whys, Fishbone).
- Collaborate cross-functionally during manufacturing and process improvements.
- Contribute to SOP revisions, quality system enhancements, and regulatory readiness.
Skills Required for the Quality Assurance Associate Role:
- Understanding of GMP regulations (21 CFR 210/211/820).
- Exposure to ICH guidelines, risk tools (FMEA, HACCP, ICH Q9).
- Strong organizational, documentation, and technical writing skills.
- Ability to multitask in a fast-paced environment.
- Proficiency in Microsoft Word, Excel, and Outlook.
- Effective communication and problem-solving abilities.
- Self-starter with the ability to work independently.
Preferred but Not Mandatory:
- ASQ Certification
- Experience with Lean/Operational Excellence
- Commercial or late-stage GMP experience
How to Apply for the Quality Assurance Associate Role?
Interested Candidates for the Biotech Job should apply through PCI Pharma Services’ official careers portal. Ensure your resume highlights GMP knowledge, QA experience, and relevant projects or internships.
