Quality Assurance Specialist

Role Summary

Quality Assurance Specialist responsible for on-the-floor QA support in biologics manufacturing operations, with weekend coverage (Wednesday through Sunday) focusing on QA activities, microbiological sampling, and testing to ensure compliance with cGMP standards 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

• Bachelor‚Äôs degree in microbiology, biology, chemistry, or a related scientific discipline.
• 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.