Quality Assurance Specialist

Job Title: Quality Assurance 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. 

This position is a 1st Shift: Tuesday-Saturday or Sunday-Thursday position

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 improve processes / procedures. Evaluate and provide QA recommendations on all products, systems, and issues that are affected or may be affected by regulatory or cGMP requirements.

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:

• 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. Audit areas to ensure compliance with cGMP, regulatory, and internal requirements.
• 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.
• Interact successfully within the highly energized production and regulatory environments, to ensure compliance, mitigate risk, and ensure products are safe for patients.
• Interacts regularly with site counterparts relating to manufacturing, testing, disposition, and cold chain documentation. The incumbent must be able to clearly communicate the cGMP requirements.
• Interacts with internal / external auditing bodies. Ability to present / describe / articulate processes, and documentation to auditors may occur.

About You

Education/Experience

• A high school diploma or equivalent is required. A bachelor's degree in a scientific discipline is preferred, along with up to 3 years of quality experience in a GMP-regulated environment.
• Accessing aseptic processing areas, sterile gowning, exceptional eyesight, sampling technique, detail oriented, are requirements to support daily activities of audit readiness and product quality testing (AQL Sampling).

Technical Skills:

• Ability to analyze complex data and identify trends, issues, and solutions
• High level of accuracy and attention to detail in all quality assurance activities
• Strong verbal and written communication skills for effective interaction with team members and regulatory bodies
• Proficiency in identifying problems and implementing effective corrective actions
• Ability to manage multiple projects simultaneously, ensuring timely completion and adherence to quality standards