Job Summary
We are seeking a QA Specialist II to join our Quality Assurance team. The ideal candidate will have experience in GMP-regulated environments and be responsible for ensuring compliance with regulatory standards, conducting quality audits, reviewing documentation, and supporting continuous quality improvement initiatives.
Key Responsibilities
1. Ensure compliance with GMP, FDA, EMA, and other regulatory requirements for manufacturing and laboratory processes.
2. Conduct batch record reviews, deviation investigations, CAPA, and change control assessments.
3. Perform internal audits and support external regulatory inspections.
4. Review and approve Standard Operating Procedures (SOPs), protocols, and validation documents.
5. Support deviation management, root cause analysis (RCA), and corrective/preventive actions (CAPA).
6. Collaborate with cross-functional teams (Production, QC, Engineering) to maintain quality compliance.
7. Ensure proper documentation and data integrity practices are followed in accordance with ALCOA+ principles.
8. Assist in supplier/vendor qualification and audits.
9. Participate in continuous improvement initiatives related to quality and compliance.
10. Train staff on quality standards, procedures, and regulatory compliance.
Requirements
1. Bachelor’s or Master’s degree in Life Sciences, Chemistry, Microbiology, Biotechnology, or a related field.
2. 3-5 years of experience in a pharmaceutical, biotech, or medical device QA role.
3. Strong knowledge of GMP, FDA, EMA, and other regulatory guidelines.
4. Experience in handling deviations, CAPA, change control, and batch record reviews.
5. Familiarity with risk assessment, root cause analysis (RCA), and audit preparation.
6. Excellent written and verbal communication skills.
7. Strong attention to detail and ability to work independently.
Preferred Qualifications
1. Experience with LIMS, TrackWise, or other quality management systems (QMS).
2. Knowledge of data integrity principles (ALCOA+), ISO 9001, and validation processes.
3. Prior experience in biologics, sterile manufacturing, or API production.
4. Certified in Lean Six Sigma, ASQ, or other quality certifications is a plus.
Benefits
1. Competitive salary and benefits package.
2. Opportunities for career growth in a leading pharmaceutical/biotech company.
3. Dynamic and collaborative work environment.
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