Manufacturing Operations Specialist

Boston Competitive p/h Contract

Job Description: Technical Operations – Manufacturing Specialist

  • Responsible for authoring and updating MBRs and Work Instructions
  • Authors deviations, change controls and CAPAs associated with manufacturing
  • Manufacturing support for Lyndra’s novel extended release of drug delivery technology
  • Provide training support for on-boarding of new manufacturing personnel
  • Perform and manage the completion of technical review of executed batch records
  • Tracking and trending manufacturing KPIs such as batch yield, equipment failures , executed batch record technical review, and manufacturing associated quality systems

Experience and Skills

  • Minimum of 2 years working in a GMP manufacturing environment
  • High level of understanding and compliance with Clean Room Environment, Good Documentation Practices and Good Manufacturing Practices
  • Minimum of 1-2 years of experience with polymer extrusion processes
  • Working knowledge of Quality Systems
  • Strong oral and written communication skills
  • Ability to work in a fast-paced cross-functional work environment
  • Strong technical writing skills required to author/revise/review Standard Operating Procedures, Work Instructions, and Master Batch Records

 Excellent computer skills including Word, Excel, and Outlook

For more information about the role and to express your interest, you can reach out to our recruiter, Daniel, directly:

Email: drichey@harbasolutions.com

Phone: 857-232-0909

About Harba Solutions:

Harba Solutions is a leading scientific services Contact your Recruiter:

firm operating across a range of scientific industries including pharmaceuticals, biotechnology, medical devices, contract research organizations, and agricultural sciences. With a substantial network of qualified scientific candidates and ongoing interactions with emerging talents, we specialize in effectively placing scientific professionals in roles encompassing laboratories, chemistry, biology, and quality-focused disciplines, to name a few. Backed by strategic investors, our core values of commitment, work ethic, team and self-ownership, craft mastery, and pursuit of success shape our mission. Explore the opportunities at Harba Solutions and become part of the evolution of scientific services.

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