Incoming Quality Auditor

Incoming Quality Auditor

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 onsite 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.

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.
• 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.
• Provide assistance 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.
• Assist Quality management in the creation of procedures and conduct internal audits as required.

Additional Responsibilities

• Participate in special project teams as assigned.
• Performs other duties as assigned based on business needs.
• Conforms with and abides by all laws, regulations, safety rules, policies, and work procedures, and all instructions.
• Exhibits regular, reliable, punctual and predictable attendance.

Education: High School Diploma or equivalent required.

Work Experience: Minimum 2 years previous/related experience in Quality Assurance/Quality Control required Preferred Knowledge, Skills and Abilities: Previous experience in Quality Assurance/Quality Control preferred. Experience in FDA regulated environment, pertinent to ISO 13485 is preferred. 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 in Lean Sigma programs and activities towards delivery of the set target.

Physical Requirements: Medium-Exerting up to 50lb/22kg of force occasionally and/or up to 20lbs/9kg of force frequently, and/or up to 10lbs/4kgs of force constantly to move objects.

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 and with customers. 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. This requires that the individual have normal hearing ability. The employee must be able to maintain concentration and visual acuity on tasks for extended periods. The employee must occasionally lift and/or move up to 35 pounds. 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. Required to work 40 hours a week and some overtime. Must be familiar and proficient with computers and various software programs such as: Microsoft Word, Microsoft Excel, Master Control, and SAP.

Shift: Monday - Friday - 1st Shift

West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. 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.