Compliance Specialist

Kelly® Science & Clinical is seeking Compliance Specialist for a 6-12 contract position at a premier client in Eugene, OR. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Pay: $30-35/hour DOE+ 

Overview

This client’s mission is to be the best global wellbeing company enhancing the everyday life of humans.
This role will give you an opportunity to advance your career in food quality.

The Document Control Specialist maintains the company’s dietary supplement compliance through the management of the document control library, the Master Manufacturing Records (MMRs) and the Batch Production Records (BPRs) according to identified policies and procedures. This position maintains a centralized documentation system for all QA related manufacturing records, SOPs and forms, and keeps record of all document numbers, document versions, superseded documents and retired documents for reference. This role is also responsible for the effective filing and retrieval of current materials and the correct archiving of completed documents.

Schedule: Mon-Fri Day

Responsibilities:

SOP Document Control:

• Responsible for the effective management and maintenance of the Document Control Library containing SOP’s, forms, and Work Instructions for all Operations Departments
  

• Oversee and validate department training with respect to SOP’s, 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

Master Manufacturing Record:

• Work with lab personnel, R&D, and or 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.
  

• When changes are made to the MMR, ensure the new version is reviewed, approved, signed and dated.

Batch Production Records:

• Responsible for tracking and filing completed Intermediate batch production records
  

• Responsible for tracking and filing completed 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
  

• Overall document control (ensuring internal forms have doc control number identification)

Other Duties:

• Invest time in researching, identifying, and making proposals for document control tools which would enable the Company to adopt Best Practices.
  

• Conduct key administrative duties including adhering to all budget guidelines.

• Regulatory & third-party audit support.
  

• Assist with other quality management initiatives as assigned.

Qualifications:

• 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.
  

• A centralized document control system

What happens next:
 
Once you apply, you’ll proceed to next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.

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