Microbiology Associate II

PCI Pharma Services•San Diego, CA

5d•Onsite

About The Position

This position is responsible for supporting manufacturing at PCI Pharma Services. The Microbiology Associate II may focus in a specialized area and provide routine analysis and testing according to standard operating procedures in any of the following areas: Gram stain, Endotoxin, Total Organic Carbon, Bioburden, Conductivity, Nitrates, Biological, Indicator Testing, Growth Promotion, Bioburden Product Qualification, Endotoxin Product Qualifications, Non-viable particulate monitoring, Viable Air Monitoring, Surface Viable Monitoring, Personnel Monitoring, and Enumeration.

Requirements

High School Diploma required.
Two to Four (2-4) years of relevant experience in cGMP/laboratory environment or equivalent.
Experience with aseptic techniques, troubleshooting, and data entry.
Ability to perform testing in a highly accurate and reproducible manner.
Proficiency with Microsoft Office applications.
Detail oriented with strong written and verbal communication skills.
Ability to work independently, within prescribed guidelines, or as a team member.
Demonstrated ability to follow detailed directions in a laboratory environment.

Nice To Haves

Bachelor’s degree in a Life Sciences discipline preferred.

Responsibilities

Performs routine Environmental Monitoring (EM) for manufacturing suites and sampling labs
Performs 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.