Associate Specialist, Quality Assurance

Job Description

Our Quality Assurance group ensures our products are manufactured, processed, tested, packaged, stored and distributed in alignment with our incredibly high standards of quality and meet 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 QLO Associate Specialist position is a direct manufacturing support role primarily on the shop floor within our Quality Line Oversight team. This team rotates through the vaccine filling and packaging departments at the West Point site providing quality and compliance oversight to our 24/7 manufacturing operations.

• Quality checks of finished product including visual inspection of vials, syringes and packages
• Verification of appropriate line clearance between batches to prevent product mix-ups
• GMP document / batch record review

• Rotational support of Quality Assurance, Quality Operations, and Environmental Monitoring providing a foundational understanding of vaccine Quality oversight and production.
• Continuous improvement projects by participating in problem solving and partnering with Operations, Technology, and/or other Quality groups in areas such as safety, quality, and efficiency

The shift structure for the position includes 12-hour day and night shifts which rotate approximately every 9 weeks. The position does require weekend coverage. Both the initial QLO assignment and future opportunities can include off-shift/off-schedule support within a vaccine manufacturing operations area.

This is an entry level position, and 0-2 years of experience in pharmaceutical industry through internships, co-operative education or other roles is preferred.

• Contributes to the performance and results of a vaccine manufacturing department.
• Provides regulatory, quality and compliance guidance.

• Applies technical, collaboration and interpersonal skills to align activities with department objectives.

• Works as a team member on shop floor core tasks, quality systems activities and/or process improvement projects.
• Has ability to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.
• Assures consistent application of standardized work, process tools, and procedures.
• Assists with regulatory inspections in either documentation area, request management area or inspection room.
• Provides quality guidance to technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control and validation.
• Effectively collaborates with peers on site and above site as required.

• Bachelor’s Degree in Engineering or Sciences

• Willing to work alternate shifts and weekends.
• Ability to focus on and obtain results
• Good verbal and written communication skills
• Ability to effectively collaborate within and across an integrated manufacturing team
• Ability to enact conflict resolution
• Ability to effectively respond to change
• Excellent analytical and organizational skills
• High personal integrity, credibility and energy
• Flexibility to perform related tasks to support the business
• Computer literacy in MS Office, Word, Outlook, Excel

• 0-2 years working experience in cGMP pharmaceutical environment
• Experience using Lean/Six Sigma tools

Ability to Coordinate, Ability to Coordinate, Analytical Problem Solving, Aseptic Filling, cGMP Compliance, Cleaning Equipment, Communication, Competency Management, Computer Literacy, Decision Making, Good Manufacturing Practices (GMP), Leadership, Manufacturing, Manufacturing Documentation, Microsoft Word, Operational Quality, Peer Reviewing, Procedure Adherence, Process Improvements, Quality Assurance Processes, Quality Compliance, Quality Management Standards, Quality Standards, Quality Support, Results-Oriented {+ 1 more}

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…