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Title:  QA Supervisor

Requisition ID:  42942
Date:  Jun 23, 2022
Location: 

Kinston, North Carolina, US

Department:  Quality
Description: 

 

 

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.

 

Essential Duties and Responsibilities:.
•    Manage and support Document Control activities
•    Manage the CAPA process including the review and approval to open new CAPA as well as approving CAPA plans, timelines and verification of effectiveness plans to assure timely completion within the established goals.
•    Ensure deviation and nonconformance reports and OOS are completed properly, including root cause investigation (if required), effective correction(s) and corrective action(s) and closed within the established goal. 
•    Support Technology Transfer process as required.
•    Support validation of facilities and equipment and process.  Approve engineering studies and other protocols as required
•    Analyze data and provide reports and recommendations to management for continuous improvements
•    Ensure proper completion of Change Controls and monitor timely completion.  Approve Change Controls for QA. 
•    Manage and oversee calibration activities
•    Complete MSAs for critical measurement systems and provide recommendations for gauging improvements.
•    Review/approve customer specifications and ensure requirements are translated into site procedures and documentation.
•    Provide for quality planning by preparing control plans and inspection documentation
•    Define strategic plan to meet company and site goals
•    Submit periodic reports on the status of compliance to quality system requirements
•    Monitor and provide guidance to pest control service provider.  Communicate pest control issues and ensure resolution. 
•    Provide expertise and guidance for deployment of statistical methods in production.
•    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.


Basic Qualifications: 
•    Education: Bachelor's in Quality, Engineering or related degree
•    Demonstrated high degree of proficiency in MS Word, Excel and other Microsoft Office Programs required.
•    Demonstrated excellent communication skills both oral and written.
•    Demonstrated ability to investigate problems and issues in order to determine the root cause of failures. 
•    Experience: 3-5 years of experience
•    Minimum five (5) years in Quality Assurance/Quality Control
•    One (1) year managing others directly

 

Preferred Knowledge, Skills and Abilities:
•    Training in Six Sigma methodology
•    Working familiarity with Project Management tools and Quality Risk Management
•    Working knowledge of Pharmaceutical Industry requirements

 

Travel Requirements:
•    Must be able to travel up to 5 % of the time.
 

 

 

 

 

 

 

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.

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