Manufacturing Quality Assurance Specialist

Business: Pharma Solutions

Department: Quality Assurance

Location: Lexington

The primary purpose of the role is to perform In-process Process QA activities, the environmental monitoring of facilities and Utility systems, Audits and QMS support according to Good Manufacturing Practices (GMP) and site specific Standard Operating Procedures (SOP).

This position reports to the Quality Assurance Supervisors

Night Shift

• Acquire an understanding of aseptic technique, continuously exhibit proper clean room behaviour, and adhere to cGMPs.
• Perform all In-process QA activities, inspection, labeling and packaging Line clearances following as per company SOP’s.
• Review executed batch records and executed protocols and meet the batch disposition timelines as per business requirement.
• Perform environmental monitoring of classified cleanroom areas (Viable Surface/air, Non-Viable air)
• Sampling and lab testing of the utilities including water, steam, and compressed gases.
• Perform plate enumeration and documentation of the results.
• Assist in the performance and documentation for cleaning verification sample collection and analysis.
• Participates in audits and involve in onsite client interactions as needed by management.
• Maintain laboratory instrumentation required for testing including calibrations.
• Aide in the maintenance of environmental monitoring trend data to drive continuous improvements and identify trends.
• Participate in Microbiology material inventory control for EM media plates.
• Prepare and summarize data associate with site metrics, write, read, and revise SOP’s QA and EM, technical reports.
• Conduct GMP investigations; specifically root cause analyses, risk assessments, and impact evaluations per PPS QMS systems.
• Adhere to all applicable regulations, policies, and procedure for health, safety, environmental compliance and support the Quality management as needed basis.

• Bachelor's Degree in physical or biological sciences or related scientific field preferred
• 1 years of Quality assurance or Environmental monitoring experience performing quality related activities within a pharmaceutical manufacturing environment
• Must have previous experience working within QA Plant support (IPQA /EM), strict regulatory guidelines, cGMP or FDA
• Prior knowledge and/or ability to understand and follow job related regulatory requirements (cGMP, OSHA, FDA)
• Proficiency in the Microsoft Office applications (Word, Excel, Outlook and Access)
• Demonstrated ability to effectively communicate both verbally and in writing
• Ability to read and follow written instructions
• Detail oriented
• Understanding of sterile manufacturing preferred
• Technical writing skills preferred