QC Chemist I

16h16 hours ago

PCI Pharma Services

Bedford, US · Full-time · $48,000 – $65,000

About this role

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 across our global network.

This position supports various activities in the Quality Control Laboratory, including testing R&D, in-process, finished product, stability, and raw materials samples. Duties include assisting in instrument validations, cleaning validations, and method qualifications as deemed appropriate by management.

Perform routine analytical testing of incoming raw materials, in-process production, finished product release, long term stability, and validation samples. Assist in deviation investigations, out-of-specification results, and process changes while documenting work in compliance with cGMP/GDP.

Work in a laboratory environment requiring ability to stand, walk, sit for prolonged periods, lift up to 50 pounds, and handle hazardous materials. Physically able to wear protective gowning, goggles, face shields, respirators, and gloves while maintaining a clean-shaven appearance.

Participate in communications between PCI, clients, and vendors for release testing, method transfers, and validations. Perform data generation, problem solving, and peer reviews to support team progress in pioneering the future of PCI.

Requirements

Ability to perform analytical testing on R&D, in-process, finished product, stability, and raw materials samples
Knowledge of cGMP/GDP requirements for documentation and laboratory work
Capability to assist in deviation investigations and out-of-specification results
Familiarity with analytical equipment validation, calibration, and preventive maintenance
Ability to stand, walk, sit for prolonged periods, reach with hands and arms, balance, talk and hear
Physically able to wear laboratory protective gowning, goggles, face shields, respirators, and protective gloves
Must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly
Comfortable with working/handling of hazardous materials and able to lift up to 50 pounds

Responsibilities

Perform routine analytical testing of samples supporting incoming raw materials, in-process production, finished product release, long term stability and validation samples
Assist in deviation investigation, out-of-specification or aberrant results and process changes
Assist in authoring and/or review of GMP documentation including test methods, protocols, reports and raw data
Perform analytical equipment validation, and ensure routine calibration and preventive maintenance is performed at the required intervals with support
Log and track samples and chemicals. Order chemicals and laboratory supplies as needed
Document/peer review laboratory work using laboratory notebooks/worksheets in compliance with cGMP/GDP requirements
Participate in communication between PCI, clients, and analytical testing vendors to support release testing, analytical methods transfer, qualification, validation and implementation
Perform routine data generation and problem solving