Quality Assurance Specialist

Role Summary

Detail-oriented Quality Assurance Specialist to support biologics manufacturing operations with weekend coverage (Wednesday through Sunday). Will perform on-the-floor QA activities, support microbiological sampling and testing, and ensure compliance with cGMP standards, internal procedures, and regulatory requirements.

Responsibilities

• Provide on-the-floor QA support for manufacturing operations across all production areas.
• Perform electronic batch record review and QA approval of in-process and finished product documentation.
• Review GMP documentation for product disposition including inventory verifications, batch records, investigations, change control, laboratory reports, validation protocols and reports, calibration and maintenance documentation, and batch summary reports.
• Conduct and support routine audits and walkthroughs of production and cleanroom areas.
• Support environmental monitoring investigations and aseptic process assessments.
• Perform microbiological sampling and testing for environmental/utility samples and personnel monitoring on weekends, ensuring compliance with compendial and internal standards.
• Collaborate with QC and Manufacturing teams to ensure timely and compliant execution of sampling plans.
• Support raw material and lot release activities and quality system updates as needed.
• Represent Quality for technology transfers and new product introductions.
• Work with accuracy, urgency, and a continuous improvement perspective.

Qualifications

• 4+ years of experience in QA or QC within a biologics or pharmaceutical manufacturing environment.
• Previous experience working in a GMP regulated facility.
• Familiarity with large molecule drug substance manufacturing, cleanroom practices, and microbiological testing methods.
• Working knowledge of microbiological sampling techniques (preferred).
• Strong understanding of cGMP, FDA, and EU regulatory requirements.
• Excellent communication, documentation, and organizational skills.
• Ability to make key quality decisions on the floor.
• Ability to work independently on a weekend schedule and collaborate effectively with cross-functional teams.
• Familiar with Master Control, LIMS, and Kneat applications.

Education

• Bachelor’s degree in microbiology, biology, chemistry, or a related scientific discipline.