QC Microbiologist I

Summary Of Objective

Conducts sampling and testing of production environments, and/or facility clean utilities, as per approved procedures. Performs Lab work and other tasks as assigned by management.

Essential Duties and Responsibilities

• Perform routine Environmental Monitoring of the classified clean rooms
• Monitor classified clean rooms during manufacturing operations, must gown qualify
• Sample and test the Water for Injection System, USP Purified Water systems and Clean Steam systems; perform and document plate reads for all environmental and utility testing with minimal supervision
• Write and execute protocols/experiments/SOPs under limited supervision
• Reviews work of peers and SOP document changes under limited supervision
• May assist senior staff in preparation of investigations, reports and execution of complex protocols
• Visual inspection of media fill vials and plates
• Perform general lab maintenance/housekeeping
• Training of staff in routine processes

Special Demands

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
• The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.

Qualifications

• A high school diploma, GED, or equivalent credential required; an AS degree or BS degree in Microbiology or related scientific field preferred.
• 3-5 years’ experience in a cGMP environment; equivalent combination of education and experience will be considered.
• Detail oriented
• Ability to multi-task
• Ability to gown to work in an ISO-5 environment
• Ability to work varied hours as required by the production schedule

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.