QA Specialist II

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:

• Ensure compliance with GMP, FDA, EMA, and other regulatory requirements for manufacturing and laboratory processes.

• Conduct batch record reviews, deviation investigations, CAPA, and change control assessments.

• Perform internal audits and support external regulatory inspections.

• Review and approve Standard Operating Procedures (SOPs), protocols, and validation documents.

• Support deviation management, root cause analysis (RCA), and corrective/preventive actions (CAPA).

• Collaborate with cross-functional teams (Production, QC, Engineering) to maintain quality compliance.

• Ensure proper documentation and data integrity practices are followed in accordance with ALCOA+ principles.

• Assist in supplier/vendor qualification and audits.

• Participate in continuous improvement initiatives related to quality and compliance.

• Train staff on quality standards, procedures, and regulatory compliance.

Requirements:

• Bachelor’s or Master’s degree in Life Sciences, Chemistry, Microbiology, Biotechnology, or a related field.

• 3-5 years of experience in a pharmaceutical, biotech, or medical device QA role.

• Strong knowledge of GMP, FDA, EMA, and other regulatory guidelines.

• Experience in handling deviations, CAPA, change control, and batch record reviews.

• Familiarity with risk assessment, root cause analysis (RCA), and audit preparation.

• Excellent written and verbal communication skills.

• Strong attention to detail and ability to work independently.

Preferred Qualifications:

• Experience with LIMS, TrackWise, or other quality management systems (QMS).

• Knowledge of data integrity principles (ALCOA+), ISO 9001, and validation processes.

• Prior experience in biologics, sterile manufacturing, or API production.

• Certified in Lean Six Sigma, ASQ, or other quality certifications is a plus.

Benefits:

• Competitive salary and benefits package.

• Opportunities for career growth in a leading pharmaceutical/biotech company.

• Dynamic and collaborative work environment.