QC Microbiology Specialist II

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Position Title: QC Microbiology Specialist II

Location: Bedford, New Hampshire

Department: Quality Control (QC)

Reporting To: QC Supervisor

Shift: Monday - Friday

Hours: 8:00am-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
• Authors, reviews, and edits documents and study protocols
• 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
• Acts as project leader for projects in the lab and department
• Leads audit readiness and participates/supports for the team
• Performs other duties, as assigned

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.

• Exceptional organizational skills, detail oriented

• Strong ability to plan and prioritize complex activities to meet goals and objectives

• Strong analytical skills to identify risks and prepare balanced decisions

• Ability to work varied hours as required by the production schedule

• People management skills
• Professional verbal communication skills required
• Solid computer skills
• Working/theoretical knowledge of lab equipment
• Ability to identify process improvements

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Required to stand; walk; sit; use hands to finger, handle or feel objects, tools or controls; reach with hands and arms; balance; talk and hear
• Ability to sit or stand for prolonged periods of time
• Must be able to walk and drive between locations
• Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves 
• Must be able to occasionally lift and/or move up to 50 pounds
• Must pass eye exam
• Comfortable with working/handling of hazardous materials

• Follow written instructions.  Perform independent troubleshooting of common issues. Provide expertise for response to complex issues.
• Able to work in a highly complex environment with competing demands and priorities

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• High school Diploma, GED, or equivalent credential required;  AS degree or BS degree in Microbiology or related scientific field preferred.
• 7-9 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.