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.
                                                       

    

Responsibilities

● 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.                      
                                                       

    

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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