Sr. Scientist, QC Systems (Validation)
Phoenix Metro Area, AZ
CORE JOB FUNCTIONS:
Perform validation/qualification on laboratory equipment and utilities, including but
not limited to HPLC, GC, FTIR, PSA, and ICP under GMP guidelines.
Write and review IQ, OQ, PQ and validation protocols including summary reports for new and
existing laboratory equipment.
Write, update, review, and approve SOPs for new and existing
Perform technical review of documents to ensure compliance with applicable regulations.
Repair and maintain labortory equipment in a validated state.
Bachelor s degree required, preferable in Science.
5 years relevant work experience required, preferably in a regulated environment.
An equivalent combination of education and experience may substitute.
REQUIRES Knowledge of USP, EP, JP and cGMP guidelines.
Advanced knowledge, operational skill, and troubleshooting of pharmaceutical laboratory
equipment (e.g., HPLC, GC, PSA, FTIR, TOC, ICP).
Advanced understanding of an instrument calibration program in a regulated environment.
Ability to write and execute instrument qualifications/validations and maintain appropriate
Advanced skills in managing complex projects.
Advanced ability to interact with internal resources, contractors and vendors to justify new
Intermediate knowledge of budgeting, sourcing and acquiring new capital equipment.
Ability to interact with regulatory auditors as Subject Matter Expert (SME) for laboratory
Advanced ability to train and coach others in laboratory maintenance.
Ability to communicate effectively with peers, department management, cross-functional peers
and global teams.
Advanced knowledge of cGMP, JP, USP and EP.
Advanced strategic thinking and ability to work independently.