QA Specialist

Job title: QA Specialist

Location: Swiftwater, PA

Monday - Friday 1st shift

About the job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?​

The QA Specialist will ensure compliance with cGMP, regulatory and internal requirements regarding the manufacturing, testing and distributing of products through formal QA Audits, investigations, training and recommendations to procedures. 

Quality oversight includes, but is not limited to deviation support, auditing of manufacturing areas for performance, regulatory audit support, documentation support, trending, adherence to site programs, and review of area release documentation following non-routine events.

This Quality position ensures Quality Compliance oversight for auditing, technical advice, real-time coaching, support traffic and gowning, aseptic technique, cleaning and disinfection, aseptic process simulation procedures, gowning scenario decision making, adherence to site programs, area releases, and other non-routine events, documentation support, trending analysis, risk assessment, CAPA and CC support and deviation support.

Foster best-in-class performance by leveraging data, technology and diverse talents to transform to a Proactive Quality Mindset and Drive Best in class Quality performance. Identify potential Simplification, Efficiency and Cost Savings gains and balance thoughtful risk taking in everyday decision making.

This position is primarily a Shopfloor position but will also have Quality System Responsibilities. This position will support all the Biologics areas as needed.
 

Main Responsibilities:

• Tagging area/equipment out of service

• Releasing area/equipment back in service

• Review Documentation – Logbooks, SRNs, Daily Releases, Batch Records, etc.

• Aseptic behavior review and coaching

• Aseptic Process Simulations / Interventions Observations

• Audits, walk-throughs, GEMBAs, technical coaching

• Deviations Support – Risk Assessments and Closures

Other Responsibilities:

• Participate in project teams involved with the facilities, processes and equipment for the manufacturing of vaccines

• Ensure a constant state of inspection readiness and all audit observations are addressed

• Support FDA and international regulatory bodies during site inspections

• Provide input and guidance to the team conducting incident investigations

• Make recommendations to department management regarding results of investigations and process improvements

• Provide direct shop floor quality support to ensure manufacturing activities are performed in compliance with effective SOPs & SWIs.

• Increase quality culture in the manufacturing areas.

• First responder to address any non-routine events on shop floor.

• Provide guidance to resolve compliance issues and procedural errors in real time.

• Perform periodic shop floor audits/walk-throughs.

• Enhance technical knowledge of operators and shop floor managers by providing positive and constructive feedback.

• CAPA and Change Control Support

About You

Basic Qualifications:

• A Bachelor’s Degree is required

• 5-7 years’ experience in a cGMP production facility

• 1-3 years' experience working with Quality systems

Technical Competencies:

• Quality Assurance experience in a Pharma/Vaccine production facility

• Working knowledge of cGMPs, Regulatory and Global requirements

• Knowledge of vaccines/biologics products and associated technologies

• Previous experience with upstream processing of Drug Substance and/or Quality Control testing in a cGMP facility

• The ability to work on cross-functional project teams

• Meet/Exceed project timelines/deliverables

• Experience with Quality Systems including SAP, Qualipso, LabWare and MS Office. Knowledge of OneQuad