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Title:  Sr. Document Control Coordinator

Requisition ID:  55635
Date:  Sep 23, 2022
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:
In this role, you will support and maintain the cGMP controlled document system to ensure documentation and record keeping processes conform to regulatory requirements as well as internally approved procedures.  Distribute documentation necessary to perform cGMP activities and manage customer documentation.

 

Essential Duties and Responsibilities:

  • Manage documentation to ensure compliance with internal procedures and regulatory requirements
  • Maintain electronic document control system to ensure fast retrieval of documents
  • Coordinate the receiving and processing of controlled documents between West and Customer
  • Coordinate the edit, review, approval and issuance of controlled documents 
  • Coordinate the issuance of controlled copies to the production floor and throughout the site where required
  • Review and route electronic document packets for processing in MasterControl 
  • Review documentation packages for accuracy and conformance to established guidelines, polices, and practices
  • Scan documents accurately and review for completeness and correctness
  • Maintain control and confidentiality of documents and information
  • Develop and implement procedures and work instructions to support Document Control activities.
  • Adept at reviewing and editing documentation
  • Drive improvements to the the effectiveness and/or efficiency of quality systems
  • Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities
  • Ability to maintain attention to detail while executing multiple tasks
  • Assign and update training in the Learning Management System
  • Assign and update curriculum in the Learning Management System
  • Support external audits for customers and regulatory agencies
  • Ability to self-manage priorities based on business needs.
  • Contributes to continuous process improvement efforts to reduce scrap, cycle times, improve efficiency, and eliminate waste within the production environment.
  • Provides a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
  • Maintains a safe, clean, and orderly workstation and environment at all times. 
  • Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
  • Exhibits regular, reliable, punctual and predictable attendance. 
  • Performs other duties as assigned based on business needs.

 

Basic Qualifications

  • Education or Equivalent Experience: High School or equivalent
  • Experience: 3-5 years of experience
  • Experience with Microsoft Office

 

Preferred Knowledge, Skills and Abilities:

  • Experience working with customers
  • Familiarity with document retention databases such as MasterControl
  • Familiarity with training modules such as Learning Management System
  • Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description 
  • Experience in a cGMP environment
  • Able to comply with the company’s safety policy at all times
  • Able to comply with the company’s quality policy at all times. 
  • Training and experience as an Internal Auditor preferred.
  • ISO 13485:2016
  • 21CFR820

 

Travel Requirements:

  • Must be able to travel up to 0% of the time 

 

Physical & Mental Requirements:

  • Medical Device manufacturing requires strict adherence to standards. Working environment is a manufacturing facility, which houses plastic injection molding machines. Must tolerate fumes and particulate generated from various plastics. Work areas are equipped with adequate lighting, cooling/heating and equipment that are in a good working condition. Must work constructively in an environment that may be stressful due to competing resources while at all times maintaining company confidentiality. 
  • Must be able to work scheduled work week, plus overtime and/or irregular hours as required to complete assignments. May stand or sit for extended periods of time. Must transport oneself to and from other areas of the facility and travel to other divisions when necessary. Must have good visual acuity. If specifically necessitated by customer requirements, must be able to see with or without corrective lenses and distinguish color differences for product and safety issues.
  • Must be able to lift and carry 25 pounds for short distances. 


 

 

 

 

 

 

 

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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