Document Control Coordinator

TriLink BioTechnologies, a Maravai LifeSciences company, is seeking a Document Control Specialist to join our growing team. This role is Responsible for maintaining the document and record control systems to support Quality Management System requirements. Responsible for coordinating the issuance, revision, review, and approval of SOPs and other documents.

Responsibilities

• Management of document change orders, reviewing, routing and tracking of new and revised documents for approval, filing of controlled documents and other documentation provided to QA, and ensuring that all documents follow the change control procedure.
• Issuing controlled copies of released documents (forms, procedures, production batch records etc.).
• Review of documents for completeness, adherence to company guidelines for formatting, review of authorization for approvals.
• Communicates issues effectively and partners with cross-functional team members to meet deadlines.
• Monitoring of status of in-process document changes to ensure timely completion.
• Organization of filing systems for electronic and paper-based GMP/Research documents.
• Review and filing of Raw Material Inspection and Release forms.
• Assisting in internal audits.
• Support the establishment and improvement of quality systems and facilitate continuous improvements efforts of the Quality System.
• Assist in quality audits, including document preparation and record retrieval.
• Update and maintain quality metrics as needed.
• Performs other duties as assigned.

Qualifications

• BS Degree in scientific area preferred.
• Quality professional with a minimum of 3-5 years of hands on experience with document contol management, preferably in a life science industry.
• Experience with ISO 9001, ISO 13485, 21CFR820, 21CFR 211, or other regulated industry a plus. DocuSign Envelope ID: 5546BC1D-03E8-40F7-A5E2-C41A96DAE6D3
• Experience with MasterControl or other document management system a plus but not required.
• Good writing skills, high degree of organization and excellent attention to detail
• The successful candidate will also demonstrate an ability to work independently and as part of a team.
• Good computer skills with working knowledge of MS office suite and Adobe Acrobat.
• Self motivated and able to organize and prioritize mulitple tasks.

TriLink BioTechnologies is a rapidly growing biotech firm in San Diego, CA, that offers competitive wages and a full benefits package including medical, dental, vision, LTD, and a retirement plan.