Quality Control Quality Checker 3rd Shift

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. How will yours help write our future?

Job Summary This role is essential in ensuring customer specifications and timelines are met and is accountable for in-process quality control services and support. The Quality Specialist role will be responsible for materials acceptance activities, provide additional quality inspection, quality control testing, sampling inspection and documentation control activities within the Quality team. The Quality Specialist will handle projects and tasks in support of product development and will play an active role to ensure products meet quality standards consistent with internal procedures and acceptance criteria, while meeting company and regulatory requirements.

Shift Days and Nights (12-hr on 2, 2, 3 rotation)

#Onsite Essential Duties And Responsibilities Provide guidance on documentation structures and format to ensure compliance to procedures, relevant regulations and standards.

Inspects in-process production by confirming specifications, conducting Visual, Dimensional and Functional tests, and communicating required adjustments to required personnel. May lead the process for raw materials acceptance activities including issuance of Certificate of Compliance.

Support batch release by completing batch card review and provide quality document control oversight on documentation and reports.

Approve batch records against approved specifications, quality standards, company procedures and regulatory filings for release of product to market.

Collaborate with teams on the development of product development DHF documents, specifically in regard to facilitating document control activities.

Calibrates all equipment gauges, measuring devices, weighing devices and hand-held gauging devices.

Work collaboratively with internal customers to refine and optimize analysis and reporting criteria as well as manage expectations around analysis delivery timelines and output capabilities.

Leading the process of the approval of all graphic and label related raw material.

Establish routine communication strategies for project tracking and prioritization.

Drive continuous quality improvement efforts to reduce scrap, cycle times, improve efficiency, and eliminate waste.

Responsible for conducting Production floor GEMBA walks.

Compliance to all Environmental, Health and Safety regulations.

Compliance to all company policies, procedures, and corporate policies.

Education High school diploma or GED required.

Bachelor's degree, vocational or technical training or degree with emphasis in Quality Control preferred.

Work Experience No minimum required.

2+ years of experience in regulated Quality Assurance/Quality Control preferred.

2+ years of experience in medical devices or pharmaceuticals industry preferred.

Effectively communicate and interface with various levels internally and with customers.

Experience with managing Document Control activities within a regulated industry.

Proficient in Windows OS, Microsoft Office Suite including Word, Excel, and PowerPoint.

Familiarity with Master Control, SAP/ERP system and SharePoint.

Travel Requirements None: No travel required

West embraces diversity and equality of opportunity. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening.

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