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Manufacturing Quality Assurance Specialist

2 months ago

Lee, Massachusetts, United States BERKSHIRE STERILE MANUFACTURING LLC Full time
Job Overview

Position Summary

The Manufacturing Compliance Specialist I is responsible for examining process discrepancies, proposing and executing effective Corrective and Preventive Actions (CAPA), conducting on-site batch record evaluations, and overseeing the continuous performance of manufacturing quality systems.

Key Responsibilities

  • Identify and analyze root causes of deviations
  • Lead investigations to ensure successful outcomes
  • Foster strong collaborative relationships across departments
  • Monitor CAPA and deviation assignments to guarantee timely completion
  • Generate reports and track metrics related to open manufacturing deviations, investigations, excursions, and CAPA
  • Maintain various quality and efficiency metrics as directed by manufacturing leadership
  • Ensure accurate and prompt completion of batch record reviews, adhering to company SOPs, cGMPs, and customer requirements
  • Assist in rectifying deficiencies identified in documentation
  • Engage in discussions regarding training adequacy and CAPA effectiveness
  • Perform additional duties as assigned by management

Regulatory Compliance

  • Conduct operations in accordance with all applicable state, OSHA, and HIPAA regulations
  • Maintain a thorough understanding of FDA, EU, and other regulatory agency requirements

Supervisory Role

  • N/A

Experience Requirements

  • A minimum of two (2) years of experience in pharmaceutical, IVD, or medical device cGMP manufacturing, with a focus on managing complex deviations using various root cause analysis methodologies preferred
  • Experience with equipment calibration and investigation of out-of-tolerance (OOT) conditions preferred
  • Prior experience with batch records is preferred
  • Relevant education may be considered in lieu of experience

Educational Background

  • Associate's degree is preferred

Knowledge, Skills & Abilities

  • Comprehensive knowledge of FDA regulations and cGMP systems
  • Applied understanding of quality by design, six-sigma, and operational excellence methodologies for creating efficient, high-quality processes and products
  • Exceptional oral and written communication skills
  • Strong technical writing capabilities
  • Familiarity with manufacturing batch records
  • Able to work independently with minimal supervision
  • Proficient in computer systems, including MS Office (Outlook, Word, and Excel)

Physical Demands

  • Regular standing and walking throughout the facility
  • Periods of sitting and typing
  • Must possess satisfactory audio-visual acuity