Title:  Document Control Specialist

Job Summary

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, and Manage the final batch review and release process. 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.

Essential Duties and Responsibilities

• Assist in managing and maintaining 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.
• Provides a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
• Assist in maintaining 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.
• Serve as System Sub-administrator of the document management system.
• Makes periodic clean-out of records and samples exceeding minimum retention requirements as per West procedures.
• Manage the final batch review and release process to ensure all batches meet defined specifications, GDP, ALCOA++, etc.
• Provide batch release documentation (COC/COA documents) to internal and external customers.
• Perform data entry tasks in support of Quality System data analysis activities/ KPIs.
• 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.

Education

• Preferred: Associate degree in technical or business-related field.

Work Experience

• Preferred: 3-5 years’ work experience in regulated Quality Control and/or Medical Device or Pharmaceutical Manufacturing Environment.
• 3+ years Document Control management activities
• 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

Preferred Knowledge, Skills and Abilities

• 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.
• Support and contribute to 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.

Travel Requirements

Physical Requirements