Quality Assurance Specialist

The Quality Assurance Specialist I ensures that manufacturing operations and quality systems comply with Standard Operating Procedures (SOPs), regulatory requirements (FDA, EU, ICH), and industry standards at a GMP manufacturing site. This role provides on-the-floor Quality Assurance oversight, reviews critical GMP documentation, and supports key quality system activities such as investigations, deviations, CAPAs, and change controls. The position actively contributes to maintaining and continuously improving the sites quality management system and quality culture through consistent application of quality processes and procedures.

• Perform on-the-floor Quality Assurance oversight of GMP manufacturing operations to ensure compliance with approved procedures and quality standards.
• Review executed batch records and GMP documentation for accuracy, completeness, and adherence to regulatory and internal requirements.
• Support investigations, deviations, CAPAs, and change controls under the guidance of sr. Quality Assurance staff.
• Identify, document, and elevate quality events, compliance risks, and atypical observations in a timely and appropriate manner.
• Partner closely with Manufacturing, Quality Control, and other support functions to ensure consistent adherence to approved procedures and quality expectations.
• Support internal audits, client audits, and inspection readiness activities by providing documentation, explanations, and on-the-floor support as needed.
• Maintain current knowledge of applicable GMP regulations, site procedures, and quality systems, and apply this knowledge in daily activities.
• Support CAPA systems, change controls, risk management activities, and general quality oversight to drive continuous improvement.
• Review GMP documentation with strong attention to detail, ensuring data integrity and traceability.
• Contribute to the maintenance and continuous improvement of the sites quality management system and quality culture through consistent use of quality processes and procedures.
• Use electronic quality systems and standard office applications to document, track, and report quality activities and issues.
• Support operations during non-standard hours when business needs require, helping to ensure uninterrupted quality oversight.

• Minimum 1+ years of GMP industry-related experience with a Bachelors Degree in Life Sciences, Chemical Engineering, Biochemical Engineering, or a related discipline.
• Working knowledge of FDA, EMA, and applicable GMP regulations and guidelines.
• Understanding of GMP manufacturing operations and quality systems within a regulated environment.
• Hands-on experience with CAPA systems, change controls, and quality oversight activities.
• Ability to review GMP documentation, including batch records, with strong attention to detail and accuracy.
• Basic knowledge of deviations, CAPAs, investigations, and change control processes.
• Strong written and verbal communication skills suitable for a regulated, documentation-heavy environment.
• Effective organizational, time management, and problem-solving abilities to manage multiple priorities.
• Proficiency with electronic quality systems and Microsoft Office applications (such as Word, Excel, and Outlook).
• Ability to identify, assess, and appropriately elevate compliance concerns and quality risks.

• Bachelors degree preferably in technology, engineering, microbiology, life sciences, or a related field; equivalent combinations of education, training, and relevant work experience are accepted.
• Familiarity with ICH guidelines and EU regulatory expectations for GMP environments.
• Experience supporting internal or client audits and regulatory inspection readiness activities.
• Comfort working cross-functionally with Manufacturing, Quality Control, and other support teams in a fast-paced environment.

This is a day-shift role on a 12-hour rotating schedule. The schedule follows a two-week rotation:
Week 1 consists of Monday, Tuesday, Friday, and Saturday;
Week 2 consists of Sunday, Wednesday, and Thursday. Standard shift hours are approximately 6:45 a.m. to 7:15 p.m., including a 30-minute lunch period. The position requires routine presence in GMP manufacturing and controlled cleanroom environments, with strict adherence to gowning requirements and the use of appropriate personal protective equipment (PPE) in accordance with site procedures. Work involves frequent…