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.
Competitive salary and benefits package.
Opportunities for career growth in a leading pharmaceutical/biotech company.
Dynamic and collaborative work environment.
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