Technician, Quality

RXinsider LTD.; Grand Rapids (MI); On-site; USD 24,796 - 38,572; Full time

Job summary

West Pharmaceutical Services in Michigan is seeking a qualified inspector to perform receiving, in-process and final inspections, review production records, and conduct analytical testing on various materials.

You will program and operate automated inspection equipment, prepare shipping documentation, and handle NCRs, DCNs, OOS, WIs, IQC forms and ECRs while maintaining compliance with FDA and ISO GMP standards. Shift 4 runs Wed, Thu, Fri, and every other Sat 5:45 PM–6:00 AM.

Qualifications

• Knowledge of FDA and ISO quality systems and GMPs.
• Experience with quality documentation and deviation handling.
• Proficiency with PC software and Microsoft Office.
• Familiarity with QMS Master Control and MeasureLink is a plus.
• Ability to prioritize and meet deadlines in a fast-paced environment.

Responsibilities

• Inspect and release incoming materials and perform analytical testing as needed.
• Review and approve Batch Production Records for each job.
• Prepare NCRs, DCNs, OOS, WIs, IQC forms and ECRs.
• Assist in design and drawing reviews and recommend improvements.
• Support shift personnel with quality issues and measurement techniques.

Skills

Quality Systems

FDA Knowledge

ISO Standards

GMPs

Attention to detail

Verbal Communication

Written Communication

Multitasking

Independent Work

Teamwork

Problem Solving

Education

High School or equivalent

Tools

Microsoft Office

QMS Master Control

MeasureLink

Job description

Description

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

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

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.

Travel Requirements

None: No travel required

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)

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status.

Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening.