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Document Control Manager/Sr. Specialist

Employer
Mission Barns
Location
San Francisco, CA
Start date
Jan 19, 2022

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Discipline
Clinical, Clinical Medicine, Regulatory
Required Education
Masters Degree/MBA
Position Type
Full time
Hotbed
Biotech Bay
About Us

Mission Barns is where some of the world’s smartest, most passionate people are pioneering the future of food. We are scaling up and optimizing our process to provide sustainable, safe, and humane meat products to the world. 

We are a venture-backed startup with decades of experience in cell biology, tissue engineering, media development, food science, bioreactor design, and more. We’re united by our collective drive to solve difficult problems, ask tough questions, and apply cutting-edge science and engineering. At Mission Barns, you’ll have the freedom to dream big and do the best work of your life.

Note: This position is 100% onsite, not remote. Document Control Manager/Sr. Specialist at Mission Barns, 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.


About You
  • 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.

Mission Barns is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status or disability status.

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