Supervisor, Manufacturing Quality AssuranceWest Pharmaceutical Services • United States
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Supervisor, Manufacturing Quality Assurance
West Pharmaceutical Services
- United States
- United States
About
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
As the Supervisor, Manufacturing Quality Assurance, you will monitor and control the daily activities of quality inspection, testing, documentation review, and calibration in support of Operations and product release. Essential Duties and Responsibilities
Provides direct supervision, resolves personnel issues, conducts performance evaluations and performs supervisory discipline as necessary. Exhibit a strong "quality first" mentality and ensure that product and process quality are held to the highest standard. Ensures compliance with quality system documents, cGMPs, ISO standards and FDA regulations. Schedule and prioritize quality inspection, testing, documentation review, and calibration to support Operations and release of product. Identifies and develops opportunities to improve existing processes and procedures. Support quality assurance improvement activities by evaluating products, processes or materials in order to develop control or improvement strategies intended to improve the customer's experience. Work with technical staff in performing root cause failure analysis and implementing corrective and preventive actions to eliminate recurrence. Assist in and manage the verbal communications and visual checks of work activity to ensure quality requirements are met. Ensure proper corrective actions, discrepancy reports and follow up activities are accomplished. Advise on equipment condition, test method, etc. to aid in the course of action when components do not meet specifications. Responsible for quality inspection and verification. Reviews documentation and records for accuracy. Determines if product is impacted, can be released, or if Non?Conformance Report is required. Assist in developing documentation and procedures during the qualification of new equipment/inspection methods. Performs other duties as assigned based on business needs. Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules. Exhibits regular, reliable, punctual and predictable attendance. Education
Education or Equivalent Experience: Associate's Degree in Technical or Engineering Work Experience
5-8 years of experience in the manufacturing industry 3+ years of Quality supervisory experience in the manufacturing industry Preferred Knowledge, Skills and Abilities
Medical Device experience preferred Metrology Equipment experience Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description Support and contribute in Lean Sigma programs and activities towards delivery of the set target Able to comply with the company's safety policy at all times Able to comply with the company's quality policy at all times Travel Requirements
Must be able to travel up to a minimal amount of the time. Physical Requirements
Must be able to work assigned shift(s) with overtime as required to complete assignments if necessary. Sitting and/or standing for extended periods may occur as well as getting to and from offices and building sites. If necessitated by customer requirements, must be able to see with or without corrective lenses and distinguish color differences for product and safety issues. Hearing ability should be sufficient to hear and react to audible alarms from distances up to 150 feet. The ability to be able to lift and carry various items up to 50 pounds for manufacturing positions or 30 pounds for administrative positions is required. 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 Apply.Accommodation@westpharma.com. 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 and/or a pre-employment drug screening.
Languages
- English
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