Position SummaryThe
Sr Specialist QA is responsible for supporting Quality Assurance activities associated with validation, commissioning, qualification, quality systems, and compliance initiatives within a regulated manufacturing environment. This role ensures that processes, equipment, facilities, utilities, and computerized systems comply with current regulatory requirements, internal procedures, and industry standards. The incumbent will provide quality oversight for validation activities, document management, risk assessments, change controls, and continuous improvement initiatives while promoting data integrity and Good Documentation Practices (GDP).
Responsibilities- Provide Quality Assurance oversight and support for Facilities and Utilities Commissioning and Qualification activities.
- Review and approve validation lifecycle documentation, including protocols, reports, discrepancies, and associated records.
- Support and evaluate Computer System Validation (CSV) activities for manufacturing and quality systems.
- Ensure compliance of equipment validation processes with applicable procedures and regulatory requirements.
- Participate in and facilitate risk assessments to support validation, qualification, and quality decisions.
- Review and approve change controls, ensuring appropriate impact assessments, risk evaluations, and implementation plans.
- Review, revise, and approve controlled documents, including Standard Operating Procedures (SOPs), protocols, reports, and work instructions.
- Ensure adherence to Good Documentation Practices (GDP) and Data Integrity requirements across all quality systems and documentation.
- Provide quality oversight for syringe and vial inspection processes to ensure compliance with established standards and procedures.
- Utilize and maintain quality and validation systems such as KNEAT, CDOCS, SCADA, TrackWise, and Maximo.
- Collaborate with cross-functional teams including Manufacturing, Engineering, Validation, and Operations to support site objectives.
- Apply decision-making methodologies and risk management principles to support quality and compliance-related activities.
- Ensure compliance with cGMPs, company policies, and applicable regulatory requirements.
Minimum Qualifications- Doctorate degree and 2 years of directly related experience; OR
- Master's degree and 4 years of directly related experience; OR
- Bachelor's degree and 6 years of directly related experience
