Specialist, Quality Systems & Compliance

Quality Assurance Associate Specialist

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and distributed aligned with our incredibly 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 deliver 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.

Primary activities could include:

• 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 (i.e., 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.

Education Minimum Requirements

High School Diploma or equivalent.

Required Experience and Skills

• 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.

Preferred Experience and Skills

Good interpersonal skills including flexibility and collaboration.

Demonstrated analytical aptitude, critical thinking skills, and problem solving.

Good verbal and written communication skills.

Required 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, Process Improvements, Quality Assurance (QA), Quality Auditing, Quality Management, Quality Management Standards, Quality Management Systems (QMS), Quality Standards, Quality Support, Root Cause Analysis (RCA), Sterile Procedures

Preferred

Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please  if you need an accommodation during the application or hiring process.

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 applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

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