Quality Assurance Specialist

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.

Job Title:

Quality Assurance Specialist

Location:

Swiftwater, PA This is a 1st shift position Sun‑Thurs or Tues‑Sat with the option for off shift depending on business needs. 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.

• 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 Parallel and CCA Sampling as required by the business.
• 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.
• Request corrections when GMP rules are not respected (D).
• Prioritize quality and compliance objectives (A).
• Proactively implement remediation action from findings from internal and external audits related to quality issues (D).
• Request quality improvement initiatives and strategies (D).
• Identify discrepancies and corrective/preventive actions that need to be taken (D) Escalate to upper management any failure in GMP execution on shopfloor (I).
• Inform relevant stakeholders and team members of quality performance, corrective actions, findings, and…