Technician, Quality
West Pharmaceutical Services · Grand Rapids, MI · 3 wk ago
EngineeringFull-time
Job Summary
Performs receiving inspections, start-up inspections, in-process and final inspections. Completes documentation & reviews production records. Performs analytical testing on various materials. Troubleshoots and solves technical problems. Programs and operates automated inspection equipment. Prepares shipping documentation & documentation audits.
Essential Duties and Responsibilities
- Inspects and release incoming materials. May perform analytical testing, evaluates, records and reports on the chemical and physical properties of various substances and materials to determine product release approval status.
- Review and approve Batch Production Records from each job.
- Compose Non-Conformance Report (NCR), Document Change Notices (DCN), Out of Specification (OOS), Work Instructions, Incoming Quality Control (IQC) forms and Engineering Change Requests (ECR’s).
- Assists in the design & drawing reviews and make recommendations for improvements, clarification, and correctness as needed.
- Assists shift personnel with quality issues and/or measurement techniques.
- Input incoming lots into expiration/retest database.
- Maintain expiration/retest date database for incoming materials. Review retest dates and arrange for testing of materials for retest. Review expiration dates and arrange for disposal of expiring materials.
- Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
- Provides a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
- Maintains a clean, orderly, and safe workstation and environment at all times.
- Other duties as assigned
Education
High School or equivalent
Work Experience
Less than 3 years of experience.
Preferred Knowledge, Skills and Abilities
- Knowledge and experience with FDA and ISO Quality Systems to include SPC and calibrations systems.
- Proficiency with PC and Microsoft Office; Knowledge of QMS Master Control, MeasureLink and other Quality systems is preferred.
- Experience with ISO 9000 standards and GMP’s
- 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.
Physical Requirements
While performing the duties of this job, the associate frequently is required to sit, walk, stand, balance, stoop, kneel, or crouch to support production needs. The associate may lift and/or move up to 25 pounds and occasionally lift and/or move more than 55 pounds.
Shift
Shift 4- Wednesday, Thursday, Friday, every other Saturday (5:45PM to 6:00AM)