Specialist, Quality Systems & Compliance

Job Description

Must be able to work 12 hour night shift 6:00 pm to 6:00 am; 2-2-3 schedule.

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and distributed aligned with our high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

The Quality Assurance Associate Specialist provides Quality support to both laboratory and manufacturing operations. The successful candidate will have the opportunity to apply their enthusiasm and skills as a member of a multidisciplinary team supporting the operation of vaccine product manufacturing facilities. The successful candidate must be able to examine issues from various perspectives, provide a hands‑on approach to problem solving, and be self‑motivated to identify and initiate process improvement projects.

The Quality Assurance Specialist provides support to vaccine, biologic, and sterile manufacturing processes through collaboration with Technical Operations.

• Perform review of batch records, laboratory records and associated documentation.
• Provide quality guidance and assistance in deviation identification and initiation.
• Perform data review and run reconciliation activities as required (e.g., UV and FIT testing).
• Learn new processes and procedures.
• Perform shift work as required.
• Support housekeeping and self‑inspections.
• Perform quality retain sample management activities, if applicable.

• High School Diploma or equivalent.

• Minimum two (2) years’ experience in Manufacturing, Maintenance, Military environments, or relative industry experience.
• Must be able to work 12 hour night shift 6:00 pm to 6:00 am; 2-2-3 schedule.

• Good interpersonal skills including flexibility and collaboration.
• Demonstrated analytical aptitude, critical thinking skills, and problem solving.
• Good verbal and written communication skills.

• Analytical Problem Solving
• Aseptic Filling
• cGMP Compliance
• Communication
• Complaint Management
• Decision Making
• Deviation Management
• Global Manufacturing
• Good Manufacturing Practices (GMP)
• Manufacturing
• Oral Communications
• Performance Improvement Plans
• Problem Solving
• Process Improvement Projects
• Quality Assurance (QA)
• Quality Auditing
• Quality Management
• Quality Management Systems (QMS)
• Quality Standards
• Quality Support
• Root Cause Analysis (RCA)
• Sterile Procedures

• Analytical Problem Solving
• Aseptic Filling
• cGMP Compliance
• Communication
• Complaint Management
• Decision Making
• Deviation Management
• Global Manufacturing
• Good Manufacturing Practices (GMP)
• Manufacturing
• Oral Communications
• Performance Improvement Plans
• Problem Solving
• Process Improvement Projects
• Quality Assurance (QA)
• Quality Auditing
• Quality Management
• Quality Management Systems (QMS)
• Quality Standards
• Quality Support
• Root Cause Analysis (RCA)
• Sterile Procedures

Benefits include medical, dental, vision, and other health insurance covering employee and family; retirement benefits, including 401(k); paid holidays, vacation, and compassionate and sick days.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status or other legally protected characteristics. We are a federal contractor and comply with all affirmative action requirements.