QA Compliance Specialist I

SHARP STERILE MANUFACTURING LLC • Lee, MA

6h

About The Position

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.

Requirements

• One (1) to three (3) years of experience working in a cGMP environment (preferably in a QA function)
• Associate’s Degree (relevant experience may be substituted for degree)
• Skilled in the use of Microsoft office applications (Word, Excel, PowerPoint) and Adobe Acrobat
• High attention to detail
• Good writing, public speaking and presentation skills
• Ability to sit for prolonged periods of time
• Ability to lift up to 25lbs
• Ability to stand for prolonged periods of time

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
• Well-organized 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
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree
• Number of Employees: 1,001-5,000 employees