Manufacturing Compliance Specialist I (2nd shift)

SHARP STERILE MANUFACTURING LLC • Lee, MA

5d • Onsite

About The Position

Investigate process deviations, propose and implement effective CAPA, perform on the floor batch record review and monitor and measure ongoing performance of Manufacturing quality systems. Conduct business in a responsible manner that complies with all state, OSHA and HIPAA regulations. Maintain a detailed and comprehensive understanding of FDA, EU and other regulatory agency requirements.

Requirements

• In-depth knowledge of FDA regulations and cGMP systems
• Applied knowledge of quality by design, six-sigma, and operational excellence tools in creating efficient and high-quality processes and end products
• Excellent oral and written communication skills
• Strong technical writing ability
• Familiarity with manufacturing batch records
• Able to work independently with minimal supervision and direction
• Proficiency with computer systems including MS Office (Outlook, Word and Excel)

Nice To Haves

• Two (2) years of work experience in pharmaceutical, IVD or Medical Device based cGMP manufacturing operations owning/leading complex deviations utilizing various root cause analysis tools
• Experience with equipment calibration and investigation of out of tolerance (OOT)
• Prior batch record experience

Responsibilities

• Determine accurate root cause
• Drive investigations to successful resolution
• Cultivate strong interdepartmental working relationships
• Track CAPA/Deviation owners to ensure on time completion
• Issue reports and track metrics of all open manufacturing deviations, investigations, excursions, and corrective and preventative actions (CAPA)
• Keep various quality and efficiency metrics as directed by manufacturing management
• Facilitate the accurate and timely completion of manufacturing review of executed batch records, ensure batch records are completed in accordance with company SOPs, cGMPs, and customer specifications
• Assist in the correction of deficiencies found within the documentation reviewed
• Facilitate sound discussions on training adequacy and CAPA effectiveness
• Other duties as required by management

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree