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Summary of Objective:

Conducts sampling of product environments, and/or facility clean utilities, as per approved procedures. Tests collected samples for the following: TOC/Conductivity, Bioburden, and Endotoxin. Performs quality control testing of in-process pharmaceutical products. Other laboratory testing as assigned.

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.

• Maintains and adheres to safe work habits and all applicable PCI safety procedures and guidelines. Is proactive in identifying safety risks and alerts management to take corrective action.

• Completes routine environmental monitoring of classified aseptic and non-aseptic areas within manufacturing facilities, as per approved procedures over multiple local production sites. Sampling includes viable and non-viable particulates, as well as contact plates.

• Completes environmental monitoring of clean rooms and operations personnel during manufacturing, as per approved procedures over multiple local production sites.

• Performs utility sampling, as per approved procedures over multiple local production sites- including purified water systems, water for injection systems, compressed air, and clean steam systems.

• Conducts coliform, bioburden, endotoxin, TOC, conductivity, and appearance testing for utility samples as well as pharmaceutical product samples.

• Performs lab maintenance tasks, such as routine cleaning of bench spaces and biological safety cabinets, stocking of supplies, and general organization.

• Completes daily and weekly assigned tasks in the Microbiology Laboratory, including product bioburdens, biological indicator testing, plate incubation and enumeration

• Performs growth promotion for media, and growth verification for prepared microorganism cultures.

• Prepares microbial growth for shipment and identification as required.

• Adheres to verbal instructions and written procedures in operating production equipment and performing processing steps; accurately completes appropriate production documentation in compliance with GDP guidelines.

• Records data and assay performance with a high attention to detail in either paper forms and/or electronic documentation systems.

• Completes data verification checks and/or inputs of trended data.

• Event reporting in the quality tracking system

• Review documentation for tasks performed by the QC department and resultant data for accuracy and traceability.

• 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.

• This position requires frequent movement between different buildings for various tasks and responsibilities.

• A key aspect of this role is the need for aseptic gowning and meticulous compliance with gowning procedures during clean room operations.

• This position is a mid-level position within the QC Microbiology group. Training team members with less experience will be encouraged for this role.

PHYSICAL REQUIREMENTS:

• Ability to wear personal protective equipment such as safety glasses/goggles, gloves and safety shoes.
• Ability to gown and gain entry to controlled manufacturing areas
• Ability to lift, pull or push equipment requiring up to 15-20 lbs of force
• Ability to stand for 6 hours in a production suite
• Ability to work any shift (up to 10 hours) as required dependent on business needs

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.

• Ability to work in a fast-paced environment
• Must be able to travel between multiple locations within Bedford and Manchester New Hampshire
• Resilient through operational change
• Able to work in a highly complex environment with competing demands and priorities
• Ability to work varied hours as required by the production schedul
• Willingness to contribute to a collaborative work environment

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.

• Exceptional organizational skills
• Following written instructions
• Detail oriented
• Ability to multi-task
• Word Processing, XL spreadsheets
• Competent in MS Office 
• Professional verbal and written communication skills required
• High school diploma with 1-2 years of experience in QC Microbiology or Environmental Monitoring, or a Bachelor’s degree in biology and 0-1 year of experience.

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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.