Quality Technician

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At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life‑saving and life‑enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun.

A name started our story. How will yours help write our future?

The role is essential in ensuring in‑process and finished products meet customer specifications. This role provides total manufacturing quality inspection services including quality inspection, quality control, sampling inspection, documentation and record keeping. Adhering to Good Documentation Process (GDP) is essential to maintain all documentation necessary to ensure conformity to specifications and traceability of records. You will assist the QA group with their daily duties including inspection, batch records, document and record control, and shipping requirements.

Conduct trainings in NC material identification and disposition.

• Point of QA contact in the Phoenix / Rockford location. This position is assigned to the Phoenix location with occasional shifts at the Rockford location.
• Organize the QA lab work loads and drive performance across the 4 QA lab shifts.
• Perform and oversee component or product inspection, sampling, analyses following standard methods and procedures, and approval/release.
• Write, review, and revise procedures, work instructions, and any related forms for specific job‑related activities.
• Conduct review of batch documentation for GMP compliance. Work with production personnel to resolve GMP discrepancies. Establish files for batch documentation.
• Work with databases to collect information and data pertaining to batch documentation.
• Perform QA release of finished product for acceptable materials.
• Disposition NC material in the Bond Room and dispositions NC material per procedures and MRB reviews.
• Assist with the calibration process by recording calibration frequencies, due dates, suppliers, and other calibration duties as required. Maintain organization of calibration activities.
• Store, record and maintain electronic and hard copies of controlled documents and records.
• Perform QA document control functions and upload records in Master Control.
• Coordinate the revision, review, and approval of SOPs and other GMP documents.
• Train existing QA Techs to the material review process for business continuity, provide continued training, as required.
• Support Continuous Improvement program throughout West Phoenix.
• Supports internal / external audits and document control.
• Perform other duties as assigned by the Quality Supervisor or Manager.
• Promote and support a Lean environment.
• Conform with and abides by all corporate and site‑specific regulations, policies, work procedures, instructions, and all safety rules.
• Exhibit regular, reliable, punctual and predictable attendance.
• Other duties as assigned.

• Proficiency with PC and Microsoft Office; knowledge of QMS Master Control, Measure Link and other Quality systems is preferred.
• Must be able to prioritize and perform position responsibilities accurately and meet required deadlines.
• Strong attention to detail; strong problem identification/analysis and solving skills with hands‑on approach.
• Excellent verbal and written communication skills; maintain an organized and clean quality lab.
• Ability to multi‑task and prioritize in a fast‑paced environment; ability to interface with all personnel levels.
• Motivated self‑starter with ability to work independently on multiple assignments in a team environment.

• Bachelor’s Degree in Technical Studies or Science or equivalent experience preferred.

• 3 years of experience required.
• Minimum 2 years of cGMP experience preferred.

• Able to be aware of all relevant…