QC Microbiology Specialist I

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

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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 Microbiology Specialist I

Location: Bedford, New Hampshire

Department: Quality Control (QC)

Reporting To: QC Supervisor

Shift: Wednesday - Saturday

Hours: 6:00am-4:30pm

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

• •Performs non-routine complex testing, identifies requirements and executes actions as part of change control process.
• •Assists and guides others in the lab with routine testing
• •Performs high throughput, right-first time work to meet production schedules and project milestones with minimal/no supervision
• •Leads qualification and study directed testing activities
• •Reviews and evaluates advanced lab testing results
• •Acts a qualified trainer and Subject Matter Expert (SME) of multiple tests
• •Supports intermediate investigations of OOS assays and events
• •Ensures compliance with cGMP and participates in audits and inspections
• •Supports laboratory management and mentors’ others on the team, as needed
• •Leads LEAN lab and six sigma principles and applies them to laboratory processes
• •Leads audit readiness and participates/supports for the team
• •Performs other duties, as assigned

Qualifications: .

High school Diploma, GED, or equivalent credential required; AS degree or BS degree in Microbiology or related scientific field preferred.

5-7 years’ experience in a cGMP environment; equivalent combination of education and experience will be considered.

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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.