Environmental Monitoring Sampler

Environmental Monitoring Sampler

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Manufacturing Shared Services Environmental Monitoring Operations is responsible for the routine/non-routine Environmental Monitoring (EM Sampling) in GMP areas of Summit West CAR-T Manufacturing and Warehouses. EM Sampler will collect environmental monitoring samples for the controlled, non-classified areas as well as controlled non-aseptic and aseptic processing areas of manufacturing.

Shift Available:

• Sunday - Thursday, Onsite Night Shift, 4 a.m. – 12:00 p.m.

Responsibilities:

• Responsible for performing sample analysis, printing of batch labels, and creating EM sample plans.
• Responsible for retrieving sample plates, sanitization of EM equipment and documentation in logbooks.
• Responsible for collection of samples per sample plan.
• Responsible for delivery of samples to QC Microbiology.
• Responsible for working in compliance with established safe work practices and procedures; properly uses personal protection and safety equipment as required by Bristol Myers Squibb (BMS)
• Reports any injury or illness immediately and notifies BMS of any hazards, unsafe acts or conditions in the workplace
• Performs routine processes following written instructions (SOP's) in support of the production of pharmaceutical products with adherence to FDA or cGMP guidance.
• Work in an aseptic production environment.
• Must be able to wear appropriate clean room attire (i.e. surgical masks, sterile gown) and all Personal Protective Equipment (PPE).
• Responsible for accurate completion of all EM Sampling documentation.
• Operate and maintain equipment and work area to ensure cleanliness and safety following GMPs and SOPs.
• Ensure that materials and equipment in the Manufacturing area are maintained in accordance with GMPs and SOPs.
• Contribute to achieving continuous improvement.
• Must work independently with minimal supervision.
• Must successfully complete training on aseptic gowning procedures and demonstrate the ability to aseptically gown.
• Ensure compliance with current Good Manufacturing Procedures (cGMP), USP, EU, and other global regulatory requirements at all times.
• Follow directions properly and work cooperatively as an individual contributor and as a team member.
• Communicate effectively with Manufacturing Operations peers, cross-functional peers, and management.
• Assist in troubleshooting and solving problems that may come up in the day-to-day operation of the department.
• Perform Environmental Monitoring on a routine and non-routine basis for all S12, S6A & S16 GMP manufacturing and associated warehouse areas.
• Assist with investigations & CAPAs associated with EM excursions.
• Perform all other duties as assigned.
• Flexibility with the schedule (weekends, holidays, extended hours, and rotating/staggered shifts) is an absolute must.

Knowledge &

Skills:

• Experience with cold chain sample storage and transfer.
• Knowledge of cGMP/FDA regulated industry.
• Basic mathematical skills.
• General understanding of cGMPs.
• Technical writing capability.
• Proficient in MS Office applications.
• Inventory control and/or management.
• Background to include an understanding of biology, chemistry, medical or clinical practices.

Minimum Requirements:

• Requires a High School diploma or equivalent.
• 1-2 years of demonstrated work experience in a regulated industry

Working Conditions:

• Ability to independently don, doff, and wear required PPE (e.g., sterile scrubs, socks, gloves, safety glasses, safety shoes) for extended periods.
• Ability to safely lift, carry, and position portable monitoring equipment (~25 lbs), including transfer on/off carts and through pass-throughs.
• Ability to safely handle chemical disinfectants, flammable materials, and hazardous chemicals.
• Ability to push and maneuver…