QA Specialist 2, Floor Support

Supports routine quality assurance operations within classified manufacturing environments, including cleanrooms. Applies Good Manufacturing Practices (cGMP) to perform defined QA activities, support real-time manufacturing operations, and ensure documentation accuracy and compliance.

Responsibilities

• Provide real-time QA support for low-complexity manufacturing and facility activities in classified environments.
• Maintain continuous on-floor presence to support compliance and production activities.
• Perform basic in-process batch record reviews to ensure accuracy and compliance.
• Review routine documentation such as logbooks, equipment use records, and cleaning logs and follow up on discrepancies.
• Conduct and verify routine line clearance activities using established procedures and checklists.
• Identify and document quality observations; escalate non-routine or higher risk issues as appropriate.
• Support deviation documentation, investigations, and remediation with guidance.
• Participate in audits, inspections, and cross-functional quality initiatives as assigned.
• Follow all gowning, safety, and cleanroom behavior requirements.

Requirements

• Bachelor’s degree in Biotechnology, Biology, Chemistry, or related field; or equivalent combination of education and experience.
• 2 years of QA experience in a GMP-regulated manufacturing, laboratory, or quality environment.
• Exposure to aseptic manufacturing preferred.

Skills

• Working knowledge of cGMP principles and quality systems.
• Ability to apply defined procedures and exercise judgement within established parameters.
• Strong attention to detail and documentation accuracy.
• Effective organizational, communication, and collaboration skills.
• Ability to perform physical tasks and work in gowning-required environments.

Schedule

• Sunday - Thursday, 7:00 AM - 3:30 PM
• Overtime and flexibility needed based on business needs

Working Conditions

• Full-time onsite work in a GMP manufacturing environment.
• Not eligible for remote or hybrid work.
• Requires full gowning and extended time in cleanroom and classified areas.
• Ability to stand for extended periods and perform physical tasks as required.