Quality Control Specialist

Responsibilities:

Support the execution of stability programs across a diverse product pipeline.

Develop and maintain stability study plans, protocols, and reports in alignment with ICH guidelines; coordinate, review, trend, and summarize test data for raw materials (including cell banks and plasmids), drug substance, and finished product.

Manage daily stability operations including receipt and processing of samples, placement into storage chambers, sample pulls, aliquoting, and coordination of internal or external testing.

Oversee and track testing activities and data flow from both internal teams and contract laboratories.

Collaborate with Quality Assurance and other cross-functional groups to assist in investigations and documentation related to deviations, CAPAs, and OOS/OOT events.

Upload and manage stability data in electronic systems to support the generation of formal reports.

Apply statistical tools to analyze and trend stability data.

Ensure strict compliance with current Good Manufacturing Practices (cGMP) and internal procedures.

Adhere to safety regulations and maintain accurate, compliant documentation.

Qualifications:

Associate degree with 4+ years or Bachelor’s degree with 2+ years in a scientific field, with experience in GMP stability testing strongly preferred.

Solid understanding of cGMP, ICH, FDA, and EU regulations related to stability.

Familiarity with aseptic processing principles and contamination control practices.

Excellent written and verbal communication skills, with the ability to collaborate effectively across teams.

Strong organizational skills and attention to detail in a dynamic, fast-paced environment.

Ability to work both independently and within a team structure.

Experience with statistical analysis tools (e.g., JMP), quality management systems, and laboratory information management systems is a plus.