Senior Specialist, Quality Assurance

Responsibilities

• Provide quality oversight and approval for manufacturing, laboratory, and quality system activities, including batch disposition, material sampling and disposition, investigations, deviations, CAPAs, change controls, risk assessments, and validation activities.
• Ensure compliance with cGMP requirements and applicable regulatory standards through review of documentation, monitoring of quality systems, and support of inspection, assembly, packaging, testing, and release operations.
• Perform reviews and approvals of investigation initial impact assessments to determine the classification of deviations.
• Support investigations to include root cause analyses, and resolution of product quality issues, implementing effective corrective and preventive actions while driving continuous improvement initiatives.
• Serve as the Quality representative and subject matter expert for cross-functional projects, technology transfers, process improvements, audits, inspections, and regulatory interactions.
• Review, approve, and maintain quality documentation, records, procedures, specifications, validation documents, and quality metrics to ensure accuracy, completeness, and compliance.
• Support incoming material and component quality activities, including inspection, sampling, testing, and release decisions, while ensuring adherence to established quality standards.
• Partner with Manufacturing, Technical Operations, Supply Chain, and Quality teams to ensure consistent execution of quality systems, successful project delivery, and uninterrupted product flow.
• Provide technical guidance, training, and direction to technicians and team members, promoting compliance, operational excellence, and a culture of quality.
• Utilize quality and business systems (e.g., SAP, MAXIMO, CMMS, electronic quality management systems) to support documentation, inventory management, data analysis, metrics reporting, and quality decision-making.
• Collaborate with MSAT, Project Management, Engineering, and other departments to ensure seamless integration of new products and technologies into the manufacturing process.
• Assist in the review and approval of new product introductions, ensuring quality standards are met throughout the product lifecycle.
• Lead risk assessments (e.g. pFMEA) and implement strategies for mitigating technical and quality risks associated with manufacturing processes.

Minimum Qualifications

• Strong technical experience in the qualification of equipment, utilities, facilities, technology transfer, statistical analysis, investigation techniques, development, and risk management methodology and process validation, and/or Quality oversight in these disciplines.
• Thorough knowledge of current industry best practices and regulatory guidance expectations regarding technology transfer and validation.
• Demonstrated experience in a regulated environment (21 CFR 210, 211, 4, 820, ISO 13485, ISO 14971, EMA, PDA, ICH, etc.)
• Knowledge of Design Controls and experience with change management.
• Strong leadership, relationship management, and organizational planning.
• Experience supporting audits and regulatory inspections.
• Experience using risk assessment tools (e.g. Failure Modes and Effects Analysis (FMEA), Hazard Analysis and Critical Control Points (HACCP), Layers of Protection Analysis (LOPA), Preliminary Hazard Analysis (PHA), simple Lean tools, etc.).
• Expertise in quality management systems.
• Excellent problem-solving skills and the ability to work under pressure in a fast-paced environment.
• Strong interpersonal skills with the ability to lead cross-functional teams and influence without direct authority.
• Excellent written and verbal communication skills, including technical writing for documents and reports.
• Ability and willingness to learn and adapt skills for various areas.
• Ability to travel approximately 5-10% based on project demand.
• Must have proficient computer skills and be experienced in Microsoft Office, including Word, Excel, PowerPoint, and Outlook.

Preferred Qualifications

• Bachelor’s degree or higher in Pharmaceutical Sciences, Chemistry, Engineering, Life Sciences, or related field.
• Minimum of 5 years of total combined experience in quality assurance and/or validation within a GMP regulated pharmaceutical and/or biotechnology manufacturing environment.
• Direct experience with GMP regulatory requirements relevant to pharmaceutical manufacturing.
• Proven track record in technical troubleshooting and root cause analysis.
• Prior cGMP inspection, medical device assembly, and/or packaging manufacturing experience.
• Experience within a multi-product facility.
• Experience with sterile manufacturing processes.
• Working knowledge of cGXP requirements for the manufacturing and inspection of pharmaceutical products.
• Previous experience in supporting regulatory inspections and audits.

Work Schedule: 12 hour – 2/2/3 Day Shift (6am - 630pm) OR Night Shift (6pm - 6:30am). This position may also include the following conditions: Sitting, Standing, Walking, Bending, Repetitive Motion, Twisting, Chemical Usage, and wearing personal protective equipment (PPE).