QC Microbiology Specialist II

PCI NH Lyophilization Services of New England; Bedford (NH); On-site; USD 80,000 - 105,000; Full time

Benefits offered by this job

null

Job summary

PCI Pharma Services in Bedford, New Hampshire, is seeking a QC Microbiology Specialist II to perform complex microbiology testing and support change control processes. The role emphasizes leadership in lab activities, cGMP compliance, and mentoring teammates in a high-throughput environment.

The candidate will participate in audits, document review, and training, while ensuring accuracy, quality, and timely project milestones within a Monday–Friday 8:00am–4:30pm shift.

Qualifications

• High school Diploma or GED required; AS/BS in Microbiology or related field preferred.
• 7–9 years in a cGMP environment or equivalent experience.
• Experience with routine and non-routine testing, change control, and study-directed testing.

Responsibilities

• Performs non-routine complex testing and supports change control.
• Guides others in routine testing and ensures compliance with cGMP.
• Leads qualification and study directed testing activities and audits.
• Mentors team members and supports LEAN lab initiatives and six sigma principles.

Skills

Analytical skills

People management

Verbal communication

Organizational skills

Detail oriented

Planning & prioritization

Lab equipment knowledge

Process improvements

Education

High school Diploma/GED

AS/BS in Microbiology or related field

Tools

Laboratory equipment

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 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

• 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 as 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

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

• 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.

#LI-CW1 Join us and be part of building the bridge between life changing therapies and patients. Lets talk future

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, 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.