Quality Technician

 

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?  

 

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.  

 

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.  

Job Summary

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.

Essential Duties and Responsibilities

• Point of QA contact in the Phoenix / Rockford location.  This position is assigned to the Phoenix location with occasionals 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.
• Conducts review of batch documentation for GMP Compliance. Works with production personnel to resolve GMP discrepancies. Establishes files for batch documentation.
• Works with databases to collect information and data pertaining to batch documentation.
• Performs QA release of finished product for acceptable materials.
• Disposition NC material in the Bond Room and dispositions NC material per procedures and MRB reviews.
• Assists with the calibration process by recording calibration frequencies, due dates, suppliers, and other calibration duties as required. Maintains organization of calibration activities.
• Store, record and maintain electronic and hard copies of controlled documents and records.
• Performs QA document control functions and upload records in Master Control.
• Coordinates 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.
• Performs other duties as assigned by the Quality Supervisor or Manager.
• Promotes and supports a Lean environment.
• Conforms with and abides by all corporate and site-specific regulations, policies, work procedures, instruction, and all safety rules
• Exhibits regular, reliable, punctual and predictable attendance
• Other duties as assigned

Additional Responsibilities

• Proficiency with PC and Microsoft Office; Knowledge of QMS Master Control, MeasureLink 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

Education

• Bachelor's Degree Technical Studies or Science or equivalent experience preferred

Work Experience

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