Document Control Manager/Sr. Specialist

This position is 100% onsite, not remote. Document Control Manager/Sr. Specialist, you will report to the Director of Quality and help lead the company’s document management and Quality compliance record keeping. You will play a crucial role in defining, executing, and improving the organization’s document management strategy. You will work closely across all aspects of laboratory work, process, and personnel to ensure excellence and compliance.
                                                       

● Lead day-to-day Document Control activities including processing Document Change Orders (DCO) and Change Requests (CR); creating, revising, review, tracking and releasing Standard Operating Procedures (SOP), Batch Production Records (BPRs), Work Instructions (WI), and other controlled documents in a timely manner while ensuring compliance with all Quality, Regulatory (21 CRF Part 11) and company standards.
● Serve as point-person/system admin for the company's electronic Document Management Systems (eDMS).
● Collaborate with cross-functional departments to ensure timely implementation of changes to controlled documents.
● Print, compile and issue all lot related documentation (batch records, forms, labels, sample plans, specifications, etc.).
● Manage paper and electronic documentation storage and retrieval processes and systems for archiving and retention of controlled documents.
● Provide support to company wide users and training of new hires and partners in Document Control processes.
● Track KPIs/metrics and report progress during Quality management reviews.
● Assist with incident investigations against lot/batch documentation and records issuance
system.
● Support internal and external audits and inspections with documentation preparation and
addressing pertinent observations/findings, as applicable.