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Quality Assurance Specialist Lot Review

Job Summary

Overall responsibilities include reviewing completed batch records for compliance and accuracy; completing all customer questionnaires and surveys provided by SCN account managers and customer service; supporting internal customer and regulatory quality audits and assisting with the training for all employees through lot review.  Supports the Quality Assurance (QA) manager by assisting with various QA functions.

Duties and Responsibilities

  • Performs QA lot review and final approval of batch production records.
  • Review critical process steps within the batch production records.
  • Real time response to operational issues in order to prevent and avoid deviations, includes immediate response to questions from Operations personnel that could potentially lead to non-conformances and failures.
  • Facilitate resolution of potential nonconformance events by working with production, QA and other groups as applicable.
  • Ensure operational compliance by making sure policies and procedures are followed.
  • Complete all customer surveys and questionnaires supplied by the sales and marketing group.
  • Assist with managing internal customer and regulatory audits as needed.
  • Other duties as assigned.

 

Qualifications, Knowledge, Skills, & Abilities

  • Minimum AA in a science or related technical field (or equivalent work experience/education).
  • Understands the dietary supplement manufacturing environment.
  • Ability to interpret and apply current cGMP regulations consistently.
  • Experience with working alongside Operational staff to ensure cGMP compliance.
  • Ability to tolerate long hours of desk work.
  • Proficient in Word, Excel and Outlook.  Sharepoint and AMAPS or other inventory control system a plus.
  • Detail oriented and able to balance priorities.
  • Excellent written and verbal communication skills.

 

Physical Requirements

The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

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