Compliance Specialist

2 weeks ago


Eugene, Oregon, United States Kelly Science, Engineering, Technology & Telecom Full time
Compliance Specialist Job Description

Kelly Science & Clinical is seeking a highly skilled Compliance Specialist to join our team in Eugene, OR. As a Compliance Specialist, you will play a critical role in ensuring our company's dietary supplement compliance through the management of the document control library, Master Manufacturing Records (MMRs), and Batch Production Records (BPRs) according to identified policies and procedures.

Key Responsibilities:

  • Manage the Document Control Library containing SOPs, forms, and Work Instructions for all Operations Departments
  • Oversee and validate department training with respect to SOPs, continuous improvement, and corrective action reporting
  • Facilitate review process of existing SOPs, work instructions, etc. to validate documents are still current within 2-year review period
  • Maintain SOP training logs
  • Work with lab personnel, R&D, and operations people to ensure revisions made to the master manufacturing documents in Exact are reflected in the hard copies maintained in the Document Control office
  • Track and file completed Intermediate batch production records and Finished Goods batch production records
  • Oversight Responsibilities: tracking and maintenance of calibration data records, tracking and maintenance of routing forms, facility, process, and equipment change control, ongoing review of production floor & sanitation and maintenance logs, review of training matrix, and overall document control

Requirements:

  • Bachelor's/associate's degree in chemistry, food science, or related discipline preferred
  • 3+ years of experience in quality
  • 2+ years of experience in document control in a regulated/ISO manufacturing environment
  • Basic Document Control Systems for Regulated Industries
  • Knowledge of 21 CFR Part 110 cGMP in Manufacturing, Packaging, or Holding Human Food
  • 21 CFR Part 111 cGMP in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements

What We Offer:

Kelly Science & Clinical offers a competitive hourly rate of $27-30/hour and a dynamic work environment with opportunities for career advancement. If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, we encourage you to apply.


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