QA Specialist

R2814113 QA Specialist

Location: Swiftwater, PA

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.

Note:

This position is a 1st shift position: Sun-Thurs or Tues-Sat

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?

Main Responsibilities:

• Ensuring that activities in his/her scope are conducted in compliance with applicable regulatory requirements

• Ensuring compliance with Good Manufacturing Practices (GMP) and other relevant regulations

• Conducting regular audits of production processes to identify and address potential quality issues

• Collaborating closely with production to ensure quality standards are maintained throughout the product lifecycle; highly recommended to be located on the shopfloor

• Managing and resolving quality-related issues in a timely and effective manner

• Monitoring and analyzing quality performance metrics, implementing corrective actions as needed

• Leading root cause analysis investigations for quality incidents and implementing preventive measures

• Participating in internal and external audits and regulatory inspections providing support and documentation

• Developing and implementing risk management strategies to mitigate potential quality issues

• Fostering a culture of quality and continuous improvement across the organization

• Ensure a constant state of inspection readiness and that audit observations are addressed on time and completed to maintain readiness levels.

• Provide daily floor coverage to support compliance of production (aseptic processing areas (sterile gowning a prerequisite), development, and testing (AQL – eye testing a prerequisite) of all products within functional areas.

• Perform cGMP audits within functional areas by conducting a thorough review of processes and documentation.  Identify and communicate cGMP compliance deficiencies to upper management, recommend appropriate corrective actions when necessary, and perform monitoring with respective functional area management to ensure compliance.

• Complete risk assessment, minor, and major incident investigations in response to any unexplained events encountered during manufacturing or out-of-specification lab results for functional areas.  Provide input and guidance to the team conducting the investigation.

• Manage the CAPA system to ensure that corrective and preventative actions are implemented and completed on time.  Provide recommendations to department management regarding CAPA development for process improvements.

• Provide support to functional areas regarding the Change Control System by providing assessments, closure, and monitoring.  Recommend documentation and supporting data to be included in the Change Control, so proper assessments of cGMP areas can be evaluated, and risk mitigated.

• Provide final signatory review for SOPs, SWIs, and Master Manufacturing Records to ensure compliance with cGMP, regulatory and internal requirements such as company guidelines and approved procedures.

About You:

• Bachelor's degree required, preferably in a scientific discipline

• 1-2 years of experience in quality assurance is preferred.

• Demonstrated knowledge of Good Manufacturing Practices (GMP) and quality assurance principles

• Experience with aseptic processing areas and sterile gowning procedures

• Strong visual acuity for detailed inspection and AQL sampling activities

• Proven ability to analyze data, identify trends, and implement solutions

• Excellent verbal and written communication skills for cross-functional collaboration

• Demonstrated capability to manage multiple priorities while maintaining quality standards.

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, we