Microbiology Associate II - 2nd Shift

We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. We are currently looking for Microbiology Associate II -2nd Shift. This position is responsible for supporting manufacturing in Environmental Monitoring at PCI Pharma Services.

Requirements

• Perform routine Environmental Monitoring (EM) for manufacturing suites and sampling labs
• Perform sampling of utilities including water, steam, and compressed gasses.
• Acceptable gowning technique for daily entry into aseptic environment
• Compiles and enters generated data into electronic databases.
• Review of generated data as a technical expert.
• Performs laboratory-testing including, but not limited to: enumeration, subcultures, Gram stains bacterial colonies, routine water testing, raw material and facility release testing and/or product testing.
• Perform product qualification testing and compiles reports.
• Assist in investigations for determination of root cause, corrections, and corrective/preventative actions for deviations, excursions and audit findings.
• Maintains lab area including routine cleaning of benches, incubators, refrigerators, and Biological Safety Cabinets.
• Ensure labs are operating in audit ready state.
• Follows Standard Operating Procedures (SOPs) to perform work in compliance with cGMPs.
• Trains new Associates on SOPs and assists in qualification tasks as assigned by senior team members.
• Provide input into technical documents such as validations, SOPs, Quality Control Qualification reports, Quality Event investigations, audit responses and trend reports with assistance from senior team members.
• Suggests possible preventative and corrective measures to improve department and works with senior team members to execute.
• Assists in data gathering and compilation for facility trending.
• Perform Batch release documentation generation and assist with lot release.
• Complies with training due dates and is accountable for training on various department functions.
• Regular and reliable attendance on a full time basis in adherence with posted schedule
• Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
• Embodies PCI Pharma Service’s cultural values and aligns daily actions with department goals and company culture.

Benefits

• Paid time off
• Health insurance coverage (including dental and vision)
• Flexible spending account
• 401(k) plan