Sr. Associate, Document Control Lead

Who We Are:

 

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:

 

Support 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 maintain customer documentation.

 

Essential Duties and Responsibilities:

 

• Maintain documentation to ensure compliance with internal procedures and regulatory requirements.
• Maintain electronic document control system to ensure prompt retrieval of documents.
• Performs document control functions, including document review, editing, tracking, processing, approval, distributing, issuance and archiving in compliance to internal and external requirements.
• Maintain the review and follow through with electronic document packets for processing in MasterControl.
• Review documentation for accuracy and conformance to established guidelines, policies, and practices.
• Maintain control and confidentiality of documents and information.
• Conducts periodic reviews of all documents to maintain consistency to customer, corporate, regulatory, or standard requirements.
• Contributes to continuous process improvement efforts to reduce scrap, cycle times, improve efficiency, and eliminate waste.
• Write or assist with the development of procedures and work instructions.
• Provides a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
• Maintain filing, record retrieval, archival, and disposition.
• Generates reports related to document control, record retention, CCN’s, Deviations, Vals, DCN’s, NCRs, Issue Reviews, Complaints, and CAPAs etc.  Conduct review and approval of the IRs, Complaints, CAPAs, and NCRs with attention to detail, review for completeness, accuracy, effectivity, and timeliness to include extension requests.
• 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.
• Establish working relationships with document management coordinators locally and with other facilities.
• Serve as System Sub-administrator of the document management system.
• Support business unit and corporate harmonization initiatives per the quality management system.
• Use independent judgment, as necessary, in developing systems/processes for use within Quality Systems
• As appropriate, take initiatives to improve the effectiveness and/or efficiency of quality systems.
• Develop training material and perform training for document and record control.
• 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.
• 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.

 

Basic Qualifications: 

 

• Associate’s degree in technical or business related field. Bachelor’s degree preferred.

• Minimum 5 years of relevant experience with document management systems (e.g. MasterControl).
• Highly proficient in MS Office applications.
• Prior QA experience preferred. 

 

Preferred Knowledge, Skills and Abilities: