• Job Description

  Req#: 503754

  
  

  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 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
  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 Responsibilities	N/A
  Experience	One (1) to three (3) years of experience working in a cGMP environment (preferably in a QA function)
  Education	Associate’s Degree (relevant experience may be substituted for degree)
  Knowledge, Skills & Abilities	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
  Physical Requirements	Ability to sit for prolonged periods of time Ability to lift up to 25lbs Ability to stand for prolonged periods of time

  
  

• About the company

  Industry leading sterile manufacturing CMO. Providing sterile fills for vials, cartridge, syringes, and lyophilized product, entirely within isolators.

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