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Scientist, Document Control

  • Location: Torrance, Los Angeles, California
  • Job Type:Contract

Posted about 1 month ago

  • Sector: Professional
  • Start Date: 2021-11-16
  • Job Ref: 21-23861
POSITION SUMMARY STATEMENT:

The Scientist, Document Control will be responsible for assuring that the existing as well as the proposed raw material specifications are in accordance with the and current regulatory requirements. The position will collaborate with cross functional teams to achieve timely approval of raw material changes.

DETAILED RESPONSIBILITIES/DUTIES:
Perform technical review of raw material documents for acceptability for Inner and/ or Outer Nutrition
Collaborate and provide guidance to Document Sourcing (Corporate and Regional) group when there are inquiries related to raw material specifications and documentation.
Collaborate and provide guidance to Document Sourcing (Corporate and Regional) group when there are inquiries related to raw material Agile processes.
Develop, review, and revise raw material specifications in Agile based on current requirements and regulations by collaborating with Research and Development (Tech Ops, Formulation), Global Regulatory Affairs and Product Compliance (Corporate and Regional), Quality Control (QC), Product Science, and Transportation to assure appropriateness.
Route raw material change requests and change orders in Agile by gathering approvals from different departments in a timely manner.
Review raw materials used in a new formula or formula revision assuring that the raw material and suppliers are approved for the contract manufacturers
Discuss specific country testing requirement with Global Regulatory Affairs and Product Compliance (Corporate and Regional), as needed.
Work with raw material suppliers or contract manufacturers (as needed) to resolve issues related to raw material specifications.
Support and provide guidance to Document Sourcing team
Inform contract manufacturers when there is a raw material specification change
Maintain all documents related to raw material
Perform other responsibilities as assigned

SUPERVISORY RESPONSIBILITIES:
None

Skills:
Basic knowledge in raw material documents and processes
High degree of attention to details to identify document acceptability
Results oriented to meet set expectations
Strong customer service and relationship
Excellent written and oral communication skills when collaborating with cross-functional teams
High analytical skills to execute changes
Excellent in planning and organization to manage multiple tasks
Proficiency in Microsoft Office
Team player
Flexible, comfortable adapting to changes
Experience:
4-5 years of experience in Quality Assurance or Quality Control in an FDA regulated industry (21-CFR- Food, Dietary Supplement or Drug)
Laboratory testing experience in (Food, Dietary Supplement, Pharmaceutical, Environmental)

Education:
Bachelors degree in a scientific field