Operations Quality Manager

2 weeks ago


Devens, Massachusetts, United States Joulé Full time

Job Overview: We are seeking a highly skilled QA Operations Specialist to join our team at Joulé. This is a challenging and rewarding role that requires a strong background in quality assurance and manufacturing compliance.

Primary Responsibilities:

  • Perform quality assurance on floor activities and ensure manufacturing compliance with applicable procedures and batch records
  • Review manufacturing shop floor documentation to identify areas for improvement
  • Direct quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies
  • Routinely recognize and resolve quality issues; inform management of proposed solutions
  • Develop and revise procedures to align with industry best practices
  • Critically review investigations, interpret results, and generate technical conclusions consistent with Quality Risk Management principles

Requirements:

  • Relevant college or university degree required in a field related to quality assurance or a similar field
  • Minimum 4 years relevant work experience, with experience in a Quality Assurance role
  • Equivalent combination of education and experience acceptable
  • Action-oriented and skilled in decision-making, building relationships, problem-solving, conflict management, planning, and organizing, resource allocation, coaching others, and analytical thinking
  • Sound knowledge and experience in FDA regulated cGMP warehousing, Quality, and compliance environments
  • Preferably knowledgeable of GMP Manufacturing operations and processes

Salary Range: $80,000 - $110,000 per year based on qualifications and experience

Benefits:

  • Eligible employees receive comprehensive health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan


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