Quality Assurance Senior Associate (24 - 7 Shift)

at  Morgan McKinley

My client is seeking a Plant Quality Assurance (PQA) Snr Associate that will report to the QA Manager and will be a core member of the site Quality Assurance team. The PQA Snr Associate will serve as Quality point of contact for manufacturing operations.
This is a 24/7 shift role required to support manufacturing operations.

BASIC QUALIFICATIONS & EXPERIENCE:

• University degree. Engineering or Science related discipline preferred.
• Relevant experience (4 yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.

PREFERRED QUALIFICATIONS & EXPERIENCE:

• Excellent written and verbal communication skills.
• Experience working with dynamic cross-functional teams and proven abilities in decision making.
• Strong organizational skills, including ability to follow assignments through to completion.
• Demonstrated ability in problem solving and experience in managing Root Cause Analysis /Deviation investigations.
• Experience working in aseptic operations, protein formulation, vial and syringe filling.
• Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues.
  Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

KEY RESPONSIBILITIES:

• Perform all activities in compliance with safety standards and SOPs.
• Write, review and approve Standard Operating Procedures in accordance with Policies.
• Provide Quality support for triage and investigation of all classes of non-conformance (NC) events.
• Review and approval of deviations for closure ensuring compliance with appropriate documentation.
• Participates in customer complaint investigations.
• Provides training and advice to staff in order for them to perform their desired functions.
• Observe and provide real-time quality oversight, and support for production unit operations, extending to formulation, vial and Syringe Fill Finish related activities, including observation and provision of direction during media fills and assessment of aseptic interventions.
• Review/approve production batch records, and associated documentation in preparation for Qualified Person disposition activities.
• Review and approve cGMP records ensuring compliance with appropriate documentation.
• Support continuous improvement and Operational Excellence initiatives.