Quality Control Supervisor

Who We Are:

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate - which all help contribute to a Healthier World.

At West, we are by the side of patients. The work we do impacts patients' lives each and every day - our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA-our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

Job Summary:

In this role, you will monitor and control the daily activities of quality inspection, testing, and documentation review, 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.

• Facilitate the growth and development of direct reports by providing guidance, training, and mentorship.

• Implement strategies to build team cohesion, enhance skill sets, and foster a collaborative and productive work environment.

• 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, and documentation review 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 of 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 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.

• May own Non-Conformances, Audit Findings, CAPAs, CAPA Actions, Issue Review, and Deviations.

• Assist in developing documentation and procedures during the qualification of new equipment/inspection methods.

• Performs other duties as assigned based on business needs.

• Create and monitor KPIs relating to Quality Control.

• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.

• Exhibits regular, reliable, punctual and predictable attendance.

Basic Qualifications:

• Education: Bachelor of Science in related field or equivalent.

• Experience: 5-8 years of experience

• Supervisor experience 5+ years

Preferred Knowledge, Skills and Abilities:

• Metrology Equipment experience.

• ISO 1345 experience

• Technical writing experience

• Goals and objective setting experience

• Sampling plan experience (statistical)

• Incoming, In-Process, and Finished Goods batch release experience.

• Root Cause Analysis and problem-solving experience.

• Change control 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 to Lean Sigma programs and activities towards delivery of the set target

• Able to comply with the company's safety and quality policies at all times.

Travel Requirements:

• Must be able to travel up to a minimal amount of time.

Physical and Mental Requirements:

• Light - exerting up to 20lbs/9kg of force frequently, and/or negligible amount of force frequently constantly to move objects. If the use of arm and/or leg control requires exertion of force greater than that of sedentary work and if the worker sits most of the time, the job is considered light work.

• 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.

#LI-KR1

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.