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QA Compliance Specialist I

3 months ago

Cape Coral, Florida, United States BERKSHIRE STERILE MANUFACTURING LLC Full time

Position Summary

  • The QA Compliance Specialist I is a quality professional who assists with compliance and quality activities at BSM. The QA Compliance Specialist assists with implementing cGMP and regulatory requirements at BSM. The QA Compliance Specialist is responsible for maintaining and improving the Quality Culture at BSM.

Duties and Responsibilities

  • Provide indirect oversight of cGMP operations at BSM
  • Work collaboratively within BSM's Quality Management System
  • Author, review and approve documentation required to comply with FDA regulations, EU regulations and other regulatory agencies as applicable
  • Author, review and approve change controls, deviations, CAPAs, work orders, and other GMP documents (will be the primary owner of the systems)
  • Perform/assist in internal audits and regular walkthrough visits to the manufacturing areas and author, review and approves associated reports
  • Work collaboratively with other departments in order to accomplish project goals
  • Assist in the execution of the Pest Control program
  • Wellorganized and proficient at reviewing and editing documentation
  • Ability to maintain attention to detail while executing multiple tasks
  • Ability to manage timelines to meet department goals
  • Maintain control and confidentiality of documents and information
  • Other duties as assigned by Manager

Regulatory Responsibilities

  • Exhibit a quality mindset
  • Conduct business in a responsible manner that complies with all state, OSHA and Federal regulations
  • Develop detailed and comprehensive understanding of FDA, EU and other regulatory agency requirements

Supervisory ResponsibilitiesN/A
ExperienceOne (1) to three (3) years of experience working in a cGMP environment (preferably in a QA function)
EducationAssociate's Degree (relevant experience may be substituted for degree)
Knowledge, Skills & Abilities

  • High attention to detail
  • Good writing, public speaking and presentation skills

Physical Requirements

  • Ability to sit for prolonged periods of time
  • Ability to lift up to 25lbs
  • Ability to stand for prolonged periods of time