Microbiology Associate II

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Job Details

We are currently seeking an Microbiology Associate II. 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.

Work Hours: 1st shift 7:00am-4:30pm or 2nd shift 2:00pm-10:30pm

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’s cultural values and aligns daily actions with department goals and company culture.
  
  

Requirements

• High School Diploma required. Bachelor’s degree in a Life Sciences discipline preferred.
• 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.
  
  

The base salary/hourly range for this position is $23.22 - $30.48 USD plus annual performance bonus eligibility. Final offer amounts are determined by multiple factors including and not limited to specific and relevant experience, credentials, geography and subject matter expertise.

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

Equal Employment Opportunity (EEO) Statement

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

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