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) Deviations, Document Change Notices (DCN), Out of Specification (OOS), Work Instructions, Incoming Quality Control (IQC) forms and Engineering Change Requests (ECR’s).
- Assist 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
Basic Qualifications:
- High School or equivalent
- 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.
Travel Requirements:
- Minimal travel may be required.
Physical and Mental 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.