1-617-500-6690 [email protected]

Company:  Confidential

Job Title: Document Control Manager/Sr. Specialist

Job Number: 30411

Location: Berkeley, CA

Job Description

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
● Support internal and external audits and inspections with documentation preparation and
addressing pertinent observations/findings, as applicable.                      


Required Skills

● Passionate about our goal of building a more sensible food system
● Bachelor’s degree and/or equivalent experience
● Minimum of 4 years of Quality document management experience in the
Biotech/Pharma/Medical Device or food tech industry preferred
● Proficient in MS Word, Excel, Power Point, Adobe Pro, and electronic document
management systems (Veeva, MasterControl, Trackwise, or equivalent).
● Solid understanding of document life cycle management and eDMS workflows.
● Working knowledge of FDA/USDA GMP requirements and ISO Standards
● Excellent organizational skills
● Strong verbal and written communication skills
● Ability to work both independently and collaboratively with scientific/technical personnel
in a fast-paced environment
● Education or training in a cell culture environment is a plus.

Full time employees enjoy medical, dental and vision coverage, flexible holiday and vacation time, stock options, and ample opportunity for career advancement as the company grows.


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