QC Environmental Monitoring Analyst II

PCI Pharma Services; Bedford (NH); On-site; USD 65,000 - 90,000; Full time

Job summary

PCI Pharma Services in Bedford, NH is seeking a QC Environmental Monitoring Analyst II to join the Quality Control team. This role focuses on routine environmental monitoring of classified clean rooms, sampling water systems, and ensuring compliance with cGMP standards.

The 12-hour rotating shift and AM hours support continuous manufacturing operations. Ideal candidates hold a high school diploma or degree in microbiology or related field, with 5–7 years in a cGMP environment and strong

Qualifications

• High school Diploma, GED, or equivalent; AS/BS in Microbiology preferred.
• 5-7 years in a cGMP environment; combination of education and experience considered.
• Detail-oriented with strong organizational skills and accuracy.
• Adaptable to changing priorities and deadlines; professional verbal communication.
• Excellent computer skills; ability to learn new software quickly.
• Ability to work varied hours as production requires and gown to ISO standards.
• Experience with lab equipment and analytical methods may be required.
• Ability to identify and implement process improvements.
• Knowledge of ISO-8 to ISO-5 gowning for controlled environments.
• Strong documentation and SOP adherence.
• Comfort with hazardous materials and safety procedures.
• Ability to collaborate across teams and train staff.

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.
• Executes protocols/experiments/SOPs under minimal supervision.
• Reviews work of peers and SOP document changes under minimal supervision.
• Assists senior staff in preparation of investigations, reports and execution of complex protocols.
• Assists in authoring and collaborating on SOP creation and updates.
• Conducts visual inspection of media fill vials and plates.
• Trains staff in routine processes.
• Performs general lab maintenance/housekeeping.
• All other duties as assigned.

Skills

Detail-oriented

Verbal communication

Computer skills

Lab instrumentation knowledge

Troubleshooting

Process improvements

Adaptability

Time management

Education

BS degree in Microbiology or related field

High school Diploma, GED, or equivalent

Tools

Laboratory instrumentation

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 II

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.
• Executes protocols/experiments/SOPs under minimal supervision.
• Reviews work of peers and SOP document changes under minimal supervision.
• Assists senior staff in preparation of investigations, reports and execution of complex protocols.
• Assists in authoring and collaborating on SOP creation and updates.
• Conducts visual inspection of media fill vials and plates.
• Trains staff in routine processes.
• Performs general lab maintenance/housekeeping.
• 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 accommodation 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.
• 5-7 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

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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.