Microbiology Associate II

Job Summary This position supports manufacturing at PCI Pharma Services. The Microbiology Associate II focuses on routine analysis and testing according to standard operating procedures in areas such as Gram stain, endotoxin, total organic carbon, bioburden, conductivity, nitrates, biological indicator testing, growth promotion, product qualification, non‑viable particulate monitoring, viable air monitoring, surface viable monitoring, personnel monitoring, and enumeration. Key Responsibilities Perform routine environmental monitoring (EM) for manufacturing suites and sampling labs. Sample utilities including water, steam, and compressed gases. Use appropriate gowning technique for daily entry into aseptic environments. Compile and enter generated data into electronic databases. Review generated data as a technical expert. Conduct laboratory testing, including enumeration, subcultures, Gram stains of bacterial colonies, routine water testing, raw material and facility release testing, and product testing. Perform product qualification testing and compile reports. Assist in investigations to determine root causes, corrections, and preventive actions for deviations, excursions, and audit findings. Maintain laboratory area, including routine cleaning of benches, incubators, refrigerators, and BSCs. Ensure labs are audit‑ready. Follow SOPs to perform work in compliance with cGMPs. Train new associates on SOPs and assist in qualification tasks as assigned. Provide input into technical documents such as validations, SOPs, QC qualification reports, quality event investigations, audit responses, and trend reports. Suggest preventive and corrective measures to improve the department and work with senior team members to execute them. Assist in data gathering and compilation for facility trending. Generate batch release documentation and assist with lot release. Comply with training due dates and be accountable for training on various department functions. Maintain regular, reliable attendance on a full‑time basis in adherence with the posted schedule. Exhibit professional behavior with internal and external associates that reflects positively on the company and aligns with company policies. Embodies PCI Pharma Service’s cultural values and aligns daily actions with department goals and company culture. Education & Experience High School Diploma required; Bachelor’s degree in a life sciences discipline preferred. 2–4 years of relevant experience in a 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 part of a team. Demonstrated ability to follow detailed directions in a laboratory environment. Physical Demands Constantly required to sit and use computers and other office equipment. Constantly required to stand for extended periods, up to four hours at a time. Frequently required to lift up to 40 pounds. Constantly required to view objects at close and distant ranges with hand and eye coordination. Frequently required to communicate with others. Compensation and Benefits The hiring rate for this position is $26.73–$30.07 per hour, plus eligibility for an annual performance bonus. PCI offers full‑time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan. Equal Employment Opportunity 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, affectionate 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. #J-18808-Ljbffr PCI TRGR Penn Pharmaceutical Services Ltd