Quality Assurance Specialist

Job description:

Job Title: Quality Assurance (QA) Specialist – QMS / Investigations (Injectables)

Location: Boca Raton

Salary: $70,000 – $80,000 per year

Experience Required: Minimum 10 years

Industry: Pharmaceutical / Biotech (Injectables)

Job Summary:

We are seeking an experienced Quality Assurance (QA) Specialist with strong expertise in Quality Management Systems (QMS) and pharmaceutical manufacturing, specifically within injectables. The ideal candidate will have extensive experience handling deviations, investigations, change control, and quality documentation while ensuring compliance with regulatory standards.

Key Responsibilities:

Manage and oversee Change Control processes to ensure compliance with internal procedures and regulatory requirements.
Conduct and review compliant investigations, including OOS (Out of Specification) and OOT (Out of Trend) events.
Review and support quality investigations related to manufacturing and laboratory activities.
Maintain and review material specifications, SOPs, and batch documentation.
Perform batch record review and batch release activities.
Ensure adherence to GMP regulations and company Quality Management System (QMS).
Collaborate with cross-functional teams including Manufacturing, QC, and Regulatory Affairs.
Support audits and regulatory inspections as needed.

Qualifications:

Minimum 10 years of Quality Assurance experience in the pharmaceutical or biotech industry.
Strong experience with injectable products.
Proven expertise in QMS, Change Control, Deviations, OOS/OOT investigations.
Experience reviewing SOPs, material specifications, and batch release documentation.
Solid knowledge of GMP regulations and regulatory compliance.
Strong analytical, documentation, and problem-solving skills.
Bachelor’s degree in Chemistry, Biology, Pharmaceutical Sciences, or related field preferred.

Compensation & Benefits: