Lead Quality Coordinator

Lead Quality Coordinator West Pharmaceutical Services - 3.4 Walker, MI Job Details 1 day ago Qualifications Microsoft Word Finished product defect inspection Document review (document control) Microsoft Excel Laboratory equipment maintenance Calibration Inventory management ISO standards 5 years Internal compliance auditing Corrective and preventive actions (CAPA) GMP Mid-level High school diploma or GED Material testing Staff training Laboratory quality control Batch records QA/QC Cleaning Fourier-transform infrared (FTIR) spectroscopy Quality audits Training & development Quality assurance within manufacturing Root cause analysis SAP ERP Implementing lean manufacturing processes Cross-functional communication FDA regulations Measurement (quality control)

Full Job Description Requisition ID:

73987

Date:

Apr 23, 2026

Location:

Walker, MI, US, 49534

Department:

Quality 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 In this role, you will support Incoming Quality functions and inspections for purchased components, raw materials, and finished goods to ensure that all received products meet quality standards and specification requirements. You will monitor and control the daily activities of quality inspection, testing, documentation review, and calibration in support of Operations and product release. You will assist the QA Supervisor in the daily scheduling, operation, evaluation and training of QA employees. Essential Duties and Responsibilities Coordinate the receipt, sampling, and inspection of incoming materials and goods Perform visual, variable, and functional inspections/testing of incoming materials to verify adherence to specification requirements and enter results within the ERP system Review supplier documentation, packaging, labels, and physical product against specifications and purchase requirements to ensure completeness and accuracy of orders Compose Non-Conformance Report (NCR) Deviations, Document Change Notices (DCN), Out of Specification (OOS), WorkInstructions, Incoming Quality Control (IQC) forms and Engineering Change Requests (ECR's). Works independently to identify Quality issues, initiate nonconformance reports, and recommend corrective actions Determine product acceptability by performing various types of inspections and measurements utilizing varying equipment, such as light inspection booth, color spectrophotometer, FTIR, gages, etc. Create, utilize, and maintain testing result forms Aid in the development of sampling plans and activities, as required Cleaning and maintaining Incoming Quality lab equipment as defined in local procedures and/or instructions Support review of batch production records and perform review, approval, and release of product and materials within the inventory management/ERP system Ensures compliance with quality system documents, cGMPs, ISO standards and FDA regulations. Work with technical staff in performing root cause failure analysis and implementing corrective and preventive actions to eliminate recurrence. Assist Quality management in the creation of procedures and conduct internal audits as required Education High School Diploma for Equivalent Work Experience Minimum 5 years previous experience in Quality Assurance/Quality Control Preferred Knowledge, Skills and Abilities Must be familiar and proficient with computers and various software programs such as Microsoft Word, Microsoft Excel, Master-control, SAP Experience with

ISO 9000

standards and GMP's Able to comply with the company's safety policy at all times Able to comply with the company's quality policy at all times. Support and contribute to Lean Sigma programs and activities towards delivery of the set target Motivated self-starter with ability to work independently on multiple assignments in a team environment Travel Requirements Physical Requirements Additional Requirements Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays, or unexpected events. Maintain high attention to detail, accuracy, and overall quality of work. Effectively communicate and interface with various levels internally. Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description. Performing the duties of this job involves the employee walking, standing on concrete floor, sitting for extended periods, lifting of cartons, containers, or bags of product, using hands and fingers to touch or feel materials or products, and listening for audible tones of equipment. The employee must be able to maintain concentration and visual acuity on tasks for extended periods. The employee must perform visual inspection of product, color standards, raw materials, and graphics. Specific vision abilities required to perform these tasks include close vision, color vision, peripheral vision, depth perception, and the ability to focus when viewing items through magnification. 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. If you have a special need that requires accommodation in order to apply to West, please send an email to . 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.

Nearest Major Market:

Grand Rapids