Manufacturing Quality Assurance Specialist

Job Title

Manufacturing Quality Assurance Specialist

Pharma Solutions

Quality Assurance

Lexington

Night Shift

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.

• 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 company SOPs.
• Review executed batch records and protocols and meet 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 utilities including water, steam, and compressed gases.
• Perform plate enumeration and documentation of the results.
• Assist in performance and documentation for cleaning verification sample collection and analysis.
• Participate in audits and engage in onsite client interactions as needed by management.
• Maintain laboratory instrumentation required for testing including calibrations.
• Aid 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 associated with site metrics, write, read, and revise SOPs QA and EM, and 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 procedures for health, safety, and environmental compliance and support the Quality management team as needed.

• Bachelor's Degree in physical or biological sciences or related scientific field preferred.
• 1 year of Quality Assurance or Environmental monitoring experience performing quality related activities within a pharmaceutical manufacturing environment.
• 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 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.