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Documentation Specialist II

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Documentation Specialist II

  • 2021-23556
  • Richmond, California, United States

The documentation team is looking for new talent to join their multifunctional team to support manufacturing activities. The position involves creating/revising documentation (production procedure/QC procedure, label, MDG change, Insert etc) and logistical activities in the documentation group. The incumbent will execute core documents involving with chemical, biological, and plastic. Other duties would include assisting with laboratory and general maintenance documents to support compliance to ISO13485 regulation standards. The incumbent will ensure adherence to documentation requirements and interact with peers and collaborating departments as needed.

Responsibilities

  • Reviews documents for format, accuracy and compliance with existing procedures, providing feedback on content as appropriate in collaboration with area experts.
  • Maintains the Document Storage Area for all controlled documents.Collaborates with the Quality department to manage and track Change Requests.
  • Creates or revises new materials and new material specifications. Creates or Revises production procedure/QC procedures. Reviews documents for format, accuracy and compliance with existing procedures, providing feedback on content as appropriate in collaboration with area experts.
  • Creates and revises label specifications in Label Content Records (LCRs), templates and processes manufacturing updates through DIR workflow.
  • Participates in CR Meetings and NPIs as required to support creating and revising documents and ERP data. • May write and revise Standard Operating Procedures and Work Instructions.
  • May create and revise sustaining Engineering drawings using AutoCad/SolidWorks.
  • May participate or lead internal audits that relate to processes for which they are responsible including manufacturing documentation, change control processes and ERP data.
  • May perform required Product Lifecycle Management (PLM) System changes through document routing approval, Tier 2, and Engineering Records (ER) release as needed.
  • Possesses a positive attitude with ability to lead a team to achieve department goals and objectives. • Good problem solving, organization, multitasking skills, required.
  • General knowledge of Good Documentation Practices (GDP).
  • Works on special projects as assigned.
  • Ability to share knowledge and train employees as needed.
  • Ability to understand processes and systems and put them into written word.

Qualifications

  • BA/BS in Life Science (Candidates with masters' degrees in Life Science are highly preferred)
  • 3-5 years experience in documentation enviroment.
  • Experience with chemical or biological techniques is preferred.
  • Ability to work independently with minimal supervision after initial training on a process.
  • Ability to multitask and manage time effectively to work in a fast paced, dynamic environment.
  • Able to be flexible and adaptable to unexpected changes in schedules and deadlines.
  • Hands on experience with SAP ERP systems and ISO13485 regulations is desirable.
  • Proficient with Microsoft Word, Excel and Powerpoint.
  • Additional experience with statistics software.
  • Strong verbal and written communication skills.
  • Result-oriented with attention to detail preferred.

About Bio-Rad:

Bio-Rad is a global leader providing a broad array of clinical diagnostics and life science research products. With a team of more than 8,000 employees and a global network of operations serving our customers, we help people live longer, healthier lives.

Bio-Rad was founded over six decades ago and has continued to provide the healthcare industry with innovative and useful products that help life science researchers accelerate the discovery process and medical diagnostic labs obtain faster, better results.

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Agency Non-Solicitation: 

Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.

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