Associate Specialist, Quality Assurance

Job description

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 Quality Line Oversight Program at West Point is an entry level 2 year program with 8 month rotations focused on providing hands-on experience in pharmaceutical quality assurance supporting our Company’s largest and most complex vaccine manufacturing plant site. This entry level program provides individuals with a range of experiences across several core quality functions fostering a foundational introduction to the vaccine manufacturing business. This multi-faceted program supports opportunities to learn, upskill, and gain meaningful experience across different parts of vaccine manufacturing, facilitating future career development and job opportunities. The successful candidate will be part of the Quality Line Oversight Program as a Quality Associate Specialist located at the West Point, PA site. In addition to hands-on shopfloor experience, the employees will be provided with an exciting opportunity to participate in a quality rotational program. This program is designed such that employees will be assigned with appropriate mentors within various key areas of the Quality organization as part of the rotation. The employees will be provided training and shadowing opportunities and will gain exposure to tasks within key areas of quality, providing the employee with a broad view of the work at West Point At the completion of the QLO program including the rotations, successful individuals will be assigned to a Quality or Operations Specialist role to further develop the individual’s knowledge of the vaccine manufacturing business as well as help position them for future career growth. The targeted start date for this position will be in Oct/Nov 2026. 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. Primary responsibilities involve: 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 Additional responsibilities include: 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. GENERAL PROFILE: Contributes to the performance and results of a vaccine manufacturing department. Provides regulatory, quality and compliance guidance. BUSINESS EXPERTISE: Applies technical, collaboration and interpersonal skills to align activities with department objectives. FUNCTIONAL EXPERTISE: 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. Education Minimum Requirement: Bachelor’s Degree in Engineering or Sciences Required Experience and Skills: 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 Preferred Experience and Skills: 0-2 years working experience in cGMP pharmaceutical environment Experience using Lean/Six Sigma tools Required Skills: 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} 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 click here 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: EEOC Know Your Rights EEOC GINA Supplement​ 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. Learn more about your rights, including under California, Colorado and other US State Acts The salary range for this role is $71,900.00 - $113,200.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The su