West Pharma Document Control Specialist 

United States, Pennsylvania, Williamsport 

5219114

In this role, you will support the 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 maintain customer documentation. This role will also be responsible for executing transactions in relevant GMP systems (MasterControl, SAP, Share Point) and other quality functions as applicable including site audit support.

• • Manage and maintain traceable, accountable, password protected, documentation system in compliance with site and corporate guidelines to handle the needs of the facility for WKIs, SOPs, ESOPs, validations, training, and other various documentation.
  • Provide instruction on documentation structures and format to ensure compliance to procedures, relevant regulations and standards.
  • Performs document control functions, including document review, editing, tracking, processing, approval, distributing, issuance and archiving in compliance to internal and external requirements.
  • Interface with department(s) SMEs with the development and documentation of problem statements, containment, implementation, correction, root cause, action plan, risk management and effective monitoring with NCRs, Issue Reviews, Complaints, and CAPAs.
  • Provide support with the customer change notification and calibration process, internal/external audits, document and record control, batch review, issue reviews, complaints, CAPAs, and shipment requirements.
  • Provides a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
  • Maintain documentation to ensure compliance with internal procedures and regulatory requirements.
  • Maintain electronic document control system to ensure prompt retrieval of documents.
  • Review documentation for accuracy and conformance to established guidelines, policies, and practices.
  • Conducts periodic reviews of all documents to maintain consistency alignment to customer, corporate, regulatory, or standard requirements.
  • Write or assist with the development of procedures and work instructions.
  • Prepares and generates reports related to document control by collecting, analyzing and summarizing data.
  • Use independent judgment, as necessary, in developing systems/processes for use within Quality Systems.
  • Serve as System Sub-administrator of the document management system.
  • Develop training material and perform training for document and record control.
  • Provide support with the internal/external audits to include monitoring audit findings.
  • Audit facilities/departments for compliance to the documented QMS and cGMP requirements.
  • Contributes to continuous process improvement efforts.
  • Other duties as assigned.

• Associate's Degree in technical or business-related field required and
• Bachelor's Degree preferred

• Minimum 3 years of experience in regulated Quality Assurance / Quality Control required and
• Relevant work history and/or experience may be considered in lieu of degree required and
• Experience with managing Document Control activities within a regulated industry required and
• Experience with quality systems such as ISO 9001, ISO 13485, 21 CFR 820 preferred and
• Experience with MasterControl (preferred) or electronic document management systems

• A thorough working knowledge of quality systems and Good Manufacturing Practices including Good Documentation Practices.
• Experience in Quality Systems Auditing against recognized Medical Device/Pharmaceutical Manufacturing Standards.
• Experience in supporting regulatory audits from US Regulatory Authorities.
• Experience with MasterControl, SAP, Share Point, Teamcenter, eCTR.
• Must have effective problem solving and interpersonal skills.
• Ability to read, write and follow verbal and written instructions.
• Ability to work independently, multi-task and thrive in fast-paced environment.
• Excellent written and verbal communication skills.
• Proficient in statistical software, Windows OS, Microsoft Office Suite including Word, Excel, and Power Point.
• Ability to make and implement decisions based on experience and facts as well as provide direction to peers or less experienced team members.
• Must have excellent communication and written skills.
• Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description.