Quality Assurance Specialist

Job Title:

Quality Assurance Specialist

The Quality Assurance Specialist provides day‑to‑day technical, quality, and operational support to pharmaceutical manufacturing operations. This role ensures that all production activities comply with cGMP standards, regulatory expectations, and safety requirements while supporting efficient, consistent, and high‑quality output. The specialist works closely with cross‑functional teams on the production floor to troubleshoot issues, maintain compliant documentation, and drive continuous improvement across processes and equipment.

• Provide floor‑level technical support to manufacturing operators and supervisors to ensure smooth and compliant production activities.
• Troubleshoot equipment issues, process deviations, and workflow bottlenecks to minimize downtime and maintain product quality.
• Monitor production performance and assist with implementing corrective and preventive actions to address quality and operational concerns.
• Prepare, revise, and maintain GMP documentation, including standard operating procedures (SOPs), batch records, logbooks, and related quality records.
• Ensure adherence to FDA and other global regulatory requirements by supporting daily operations and documentation practices.
• Support investigations into deviations and non‑conformances, assist with CAPA development, and participate in change control processes.
• Perform data collection, analysis, and review to support compliance, trend monitoring, and continuous improvement initiatives.
• Partner with process control teams to support equipment qualification and validation activities in accordance with regulatory and internal standards.
• Assist with process improvements, optimization initiatives, and technology transfers to enhance efficiency and product quality.
• Support coordination of preventive and corrective maintenance activities with Engineering and Maintenance departments to maintain equipment reliability.
• Train manufacturing personnel on procedures, new equipment, and process changes to ensure consistent understanding and execution.
• Act as a subject matter liaison between Production, Quality, and Maintenance teams to facilitate clear communication and alignment.
• Communicate production issues, progress updates, and risks to leadership in a timely and accurate manner.
• Uphold and promote a strong culture of safety and compliance on the production floor, reinforcing best practices and expectations.
• Participate in internal and external audits, walkthroughs, and safety reviews to support inspection readiness and continuous improvement.
• Support environmental monitoring and compliance activities as needed to maintain controlled manufacturing environments.
• Perform quality assurance activities such as in‑process quality checks, inspections, and oversight of quality control practices.
• Contribute to audit preparation and response efforts to ensure quality systems and processes remain robust and inspection‑ready.

• 1–3+ years of experience in a pharmaceutical, biotech, or other regulated manufacturing environment.
• Working knowledge of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
• Understanding of applicable regulatory guidelines and expectations for regulated manufacturing.
• Strong analytical and problem‑solving skills with the ability to troubleshoot technical and process issues.
• Excellent communication skills, both written and verbal, to support documentation, training, and cross‑functional collaboration.
• Strong documentation skills with attention to accuracy, completeness, and compliance.
• Demonstrated ability to work effectively in a fast‑paced, highly regulated environment.
• Experience supporting quality assurance activities such as quality checks, inspections, and audits.
• Familiarity with environmental monitoring and quality control concepts in manufacturing settings.
• High attention to detail and accuracy in all aspects of work.
• Technical troubleshooting skills related to processes, equipment, and production workflows.
• Strong collaboration and cross‑functional communication skills to work with Production, Quality, Engineering, and Maintenance teams.
• Effecti…