QC Environmental Monitoring Analyst III Lead

PCI NH Lyophilization Services of New England; Bedford (NH); On-site; USD 75,000 - 110,000; Full time

Benefits offered by this job

Competitive rewards program

Job summary

PCI Pharma Services in Bedford, New Hampshire is seeking a QC Environmental Monitoring Analyst III to join the Quality Control team. The role focuses on environmental monitoring of classified clean rooms, utility sampling, and data review in a cGMP environment.

The position requires gown qualification, strong documentation skills, and the ability to support cross-functional teams. This is a full-time, on-site role with a 12-hour rotating shift schedule.

Qualifications

• AS/BS in Microbiology or related field (preferred).
• 7–9 years in a cGMP environment or equivalent.
• Gown qualification and ability to work in ISO-8 to ISO-5 environments.
• Strong attention to detail and organizational skills.
• Proficient in data review and documentation practices (GDP/ALCOA+).

Responsibilities

• Performs routine Environmental Monitoring of the classified clean rooms.
• Performs routine utility sampling and analysis of Water for Injection Systems, RO/DI, USP Purified water systems, and Clean Steam systems.
• Monitors classified clean rooms during manufacturing operations; must be gown qualified.
• Performs routine monitoring and analysis of the Clean Compressed Air System.
• Writes and executes protocols, experiments, and notebook studies.
• Reviews work of peers for GDP and ALCOA+.
• Performs data review of paper and electronic records.
• Handles preparation of investigations, reports and execution of complex protocols.
• Conducts visual inspection of media fill vials and plates.

Skills

Environmental Monitoring

cGMP knowledge

Gown qualification

Data analysis

Laboratory equipment

Education

BS in Microbiology or related field

AS/2-year degree in Microbiology or related field

High school Diploma or GED

Tools

LIMS

Microsoft Excel

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 Environmental Monitoring Analyst III

Lead

Location: Bedford, New Hampshire

Department: Quality Control (QC)

Reporting To: QC Supervisor

Shift: 12 hour rotating (2,2,3)

Hours: AM

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 routine Environmental Monitoring of the classified clean rooms.
• Performs routine utility sampling and analysis of Water for Injection Systems, RO/DI, USP Purified water systems, and Clean Steam systems.
• Monitors classified clean rooms during manufacturing operations; must be gown qualified.
• Performs routine monitoring and analysis of the Clean Compressed Air System.
• Writes and executes protocols, experiments, and notebook studies.
• Authors and collaborates on SOP creation and updates.
• Reviews work of peers for GDP and ALCOA+.
• Performs data review of paper and electronic records.
• Handles preparation of investigations, reports and execution of complex protocols.
• Conducts visual inspection of media fill vials and plates.
• Assists with scheduling routine work and support coverage.
• Performs general lab maintenance/housekeeping.
• Trains staff in routine and advanced processes.
• Attends and contributes to cross-functional meetings as needed.
• All 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.

• 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.
• 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.
• Highly detail-oriented
• Easily adaptable to changing priorities and deadlines
• Exceptional organizational skills
• Professional verbal communication skills required
• Excellent computer skills; the ability to learn new software
• Ability to work varied hours as required by the production schedule
• Working/theoretical knowledge of lab equipment
• Ability to identify and execute process improvements
• Ability to gown to work in an ISO-8 through ISO-5 environment

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

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.