Quality Assurance Specialist

About the Job

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.

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

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 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.

Key involvement in Decision Making process

• 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 preventive measures (I)
• Advise on how to present a topic and answer specific questions (A)
• Advise on risk management strategies and plans (A)
• Advise on initiatives to promote a quality-focused culture (A)

About You

Basic Qualifications

• Bachelor's Degree
• 3+ years quality experience preferred in a GMP regulated environment.

Preferred Qualifications

• Accessing aseptic processing areas, sterile gowning, exceptional eye sight, sampling technique, detail oriented, are requirements to support daily activities of audit readiness and product quality testing (AQL Sampling).
• 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