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Title:  Document Control Supervisor

Requisition ID:  60180
Date:  Jan 26, 2023
Location: 

Tempe, Arizona, 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.

 

Job Summary:

 

The Quality Assurance Document Control Supervisor is responsible for managing the review, release and retention process for documentation relating to all current good manufacturing practice (cGMP), Standard Operating Procedures (SOP) and FDA Regulations/Guidelines. The Document Control Supervisor is also responsible to directly oversee the disposition/release of product to customers or market.

 

Essential Duties and Responsibilities:

  • Supervise the Document Control Department activities
  • Ensure document quality and compliance with established policy and procedural framework
  • Create and ensure an organized environment for easy access to all documents in a timely manner
  • Oversee periodic review of all documents to maintain consistency to customer requirements (e.g. SOPs, DOIs, QAIs, QAFs, 800 & 900 series).
  • Oversee completed product batch records for release and holds
  • Coordinate with cross functional teams to prioritize batch releases to meet customer delivery requirements
  • Support all audits including but not limited to Regulatory bodies (eg. FDA), Customer and Internal
  • Reviews findings, and monitors compliance trends related to procedural documents and communicates compliance issues/concerns to department manager.
  • Provide an interface with D&T for Document Control issues, which include process enhancements to existing software, developing recommendations for new hardware and/or software that may benefit the Document Control environment
  • Process map site procedure documents and identify improvement opportunities including procedural document consolidation, streamlining and simplification.
  • Develops direct report(s) through orientation, training, establishment of objectives, communication of rules and policies while building employee morale and motivation.
  • Communicates goals and objectives, applies company policy, administers discipline, insures positive employee relations and reviews the performance of direct reports.
  • Maintains time and attendance records for direct reports
  • Other continuous improvement projects and duties as assigned by Senior Management
  • Coordinate communications regarding documentation controls
  • Provides a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
  • Maintains a clean, orderly, and safe workstation and environment at all times.
  • Other duties as assigned

 

Education and Experience:

  • Education: College
  • Experience: Less than 3 years
  • Associate’s degree preferred. High school diploma or equivalent required
  • 1-2 years related experience with document management systems, preferably MasterControl.
  • Highly proficient in MS Office applications

 

Knowledge, Skills and Abilities:

  • Strong Good Documentation Practice and Good Manufacturing Practice skills
  • Ability to read and interpret FDA regulations and guidelines as they apply to documentation
  • Extensive knowledge of cGMPs
  • Proficiency in Microsoft Word, Excel, Outlook and graphs/charts and similar office applications
  • Ability to communicate effectively (in person and in writing), compile, manage and interpret data
  • Technical writing skills is preferred
  • Excellent organizational skills with close attention to detail and accuracy
  • 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.

 

 

 

 

 

 

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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