Specialist, Quality Assurance; Second Shift

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and distributed aligned with our quality standards 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 Specialist provides Quality support to laboratory and/or manufacturing operations. The successful candidate will have the opportunity to apply their enthusiasm and skills as a member of a multidisciplinary team supporting the operations of pharmaceutical, biologic, and/or vaccine manufacturing facilities. The successful candidate must be able to examine issues from diverse perspectives, provide a hands‑on approach to problem solving, and be self‑motivated to identify and lead process improvement projects.

• Reporting to the Quality Assurance Organization, will independently manage project assignments.
• Ensure individually assigned aspects of the project proceed in compliance with cGMP, regulations, and our Company’s Quality Management System.
• Provide QA shop floor support in the execution and review of GMP documentation such as IQ, OQ and other technical documents to meet schedule milestones.
• Provide QA shop floor support on batch review, alarm response, incursion response and deviation management.
• Provide QA shop floor support on aseptic techniques, aseptic observations, cleaning techniques, and gowning observations.
• Partner with site functions to solve problems and achieve goals.
• Makes decisions guided by policies and procedures that impact the team’s ability to meet performance objectives.
• Consults on an as‑needed basis with next level manager on more complex decisions.
• Executes critical site review and review of environmental monitoring data.
• Perform review of process simulation batch records.
• Lead Shopfloor audits to identify and address housekeeping and/or compliance gaps.
• May approve incidents and investigation related to deviation management.
• Assists cross‑functional team with executing and approving change controls.
• Approve cleaning validation documentation as needed.
• May act as a Quality Risk Assessment Lead.

High School Diploma or equivalent

Minimum four (4) years of experience in manufacturing, maintenance, laboratory, military environment, or related industry including two (2) years of experience in a GMP or FDA regulated industry.

Monday
- Friday, 2:00 PM - 10:30 PM EST (will include weekends and holidays to support ongoing manufacturing activities).

• At least 1 year of experience in aseptic manufacturing or other clean room environment.
• Strong contemporary knowledge of relevant current good manufacturing practices (cGMPs), regulations and current industry trends.
• Effective decision making, problem solving and communication skills.
• Ability to manage multiple priorities.
• Demonstrated ability to work in fast‑paced, complex environments and elevate appropriately.
• GMP quality experience with biological drug substance or drug product.
• GMP experience with qualification of equipment.
• Experience with Quality Risk Management.
• Project Management experience in a highly regulated industry.
• Experience with Kneat, SAP, Veeva and/or GLIMS.
• Experience in deviation management with focus on quality review and approval.
• Experience in Aseptic processing, aseptic observations, and techniques.
• Electronic manufacturing batch records (eM ) experience.
• Demonstrated interpersonal skills including…