Qc Microbiologist I

PCI TRGR Penn Pharmaceutical Services Ltd; Bedford (NH); On-site; USD 60,000 - 75,000; Full time

Job summary

PCI Pharma Services in Bedford, New Hampshire, is seeking a QC Microbiologist to support environmental monitoring and utility testing in a cGMP setting. You will perform sampling, testing, and routine lab tasks in a fast-paced quality control lab.

The role requires 3–5 years of cGMP experience, a degree in Microbiology or related field, and the ability to write protocols and SOPs under limited supervision; shift is 1st, 8:30am–5:00pm, Monday–Friday.

Qualifications

• 3–5 years' experience in a cGMP environment; 2 years may be replaced by Associates/Non-Scientific Bachelor's degree.
• Four years of experience may be replaced with BS/BA degree in Microbiology or related field.
• Position requires ability to write and execute procedures under limited supervision.

Responsibilities

• Perform routine Environmental Monitoring of the classified clean rooms.
• Monitor classified clean rooms during manufacturing operations; gown qualify as required.
• Sample and test Water for Injection, USP Purified Water, and Clean Steam systems; perform plate reads with minimal supervision.
• Write and execute protocols/experiments/SOPs; review peers' work and SOP changes.
• Assist senior staff with investigations, reports, and complex protocols.
• Visually inspect media fill vials and plates; train staff in routine processes.

Skills

Environmental Monitoring

Gowning qualification

Laboratory testing

Protocol writing

SOP documentation

Education

BS/BA in Microbiology or related field

Associates or non-scientific Bachelor's degree acceptable with 2 years experience

Job description

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.

Position Title: QC Microbiologist

Location: Bedford, New Hampshire

Department: Quality Control (QC)

Reporting To: QC Supervisor

Shift: 1st (Monday - Friday)

Hours: 8:30am-5:00pm

Job Summary: 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
• Other duties as assigned

QUALIFICATIONS

Required: 3-5 years' experience in a cGMP environment. Two years of experience may be replaced by Associates/Non- Scientific Bachelor's degree. Four years of experience may be replaced with BS/BA degree in Microbiology or related scientific field.

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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.

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.