QA Specialist

Responsibilities

• Maintain a daily presence on the production floor to provide real-time QA support and guidance.
• Ensure adherence to batch records, SOPs, and validated procedures during manufacturing, packaging, and inspection activities.
• Perform QA line clearances, in-process checks, and AQL inspections, and support visual inspection and automated inspection processes.
• Act as a Designated Observer for controlled substance handling, ensuring compliance with internal and regulatory requirements.
• Routinely walk through production, lab, and warehouse areas to assess GMP compliance and escalate issues as needed.
• Verify labeling issuance, reconciliation, and documentation to ensure proper handling of materials and finished products.
• Provide on-the-floor coaching and guidance to operators, reinforcing GMP compliance and best practices.
• Collaborate with Manufacturing and Planning teams to prioritize lot disposition, minimize downtime, and support operational flow.
• Monitor cleaning, sanitization, and environmental controls prior to critical operations.
• Promote a quality-focused culture by sharing lessons learned and encouraging proactive issue identification.
• Maintain knowledge of deviation, OOS/OOT, and CAPA processes to support investigations if required.
• Assist in gathering facts, reviewing documentation, and providing QA input when deviations occur on the floor.
• Understand root cause analysis tools (5 Whys, Fishbone, FMEA) to support quality discussions.
• Review, revise, and proofread GMP documentation, including batch records, SOPs, and logbooks.
• Support document control processes and ensure training documentation is correctly linked to controlled systems.
• Ensure compliance with regulatory standards (FDA, ICH, DEA) and Good Documentation Practices.
• Conduct routine walk-throughs to maintain inspection readiness.
• Support internal audits and regulatory inspections by providing floor-level guidance and documentation as needed.

Qualifications

• Bachelor’s degree in a scientific discipline or equivalent experience.
• 2–5 years in a GMP-regulated environment, with experience in on-the-floor QA support.
• Knowledge of cGMPs, FDA/ICH regulations, and QA documentation practices.
• Familiarity with Master Control or electronic quality systems preferred.
• Strong communication, problem-solving, and interpersonal skills.
• Ability to work flexible shifts, including evenings or weekends as required.
Preferred Qualifications:
• Experience with automated visual inspection processes.
• Knowledge of controlled substance handling.
• Prior involvement in regulatory inspections.

Work Environment & Physical Demands

• Regular presence in GMP manufacturing and cleanroom environments with proper gowning.
• Occasional off-shift, weekend, or extended coverage may be necessary.