Technical Operations Lead

7 days ago


Devens, Massachusetts, United States Joulé Full time

About Joulé

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Joulé, a forward-thinking company, offers a dynamic environment for professionals to thrive. As our ideal candidate, you will be part of a team that values expertise and innovation.

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Salary: $120,000 per annum

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We are seeking a highly skilled QA Technical Operations Lead to join our team in Devens, MA. This role is responsible for providing quality assurance support to the site and reporting manager through quality review and approval of investigations and corrective actions.

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Key Responsibilities:

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  • Decision making of non-conformance through a deep understanding of Quality Systems Regulatory expectations">
  • Reviews and approves Quality, Quality Control, Validation, and Automation related documents">
  • Review and approval of Validation related documentation such as risk assessments, protocols, and test scripts and summary reports">
  • Review and approval of change proposals as well as associated deliverables, ensuring the change deliverables meet external regulatory and internal WWQC guidelines and requirements">
  • Able to coach across different departments within the subject matter of Investigations, CAPAs, general risk assessments, and Validation">
  • Able to self-manage and prioritize work across multiple competing deliverables, in a remote working environment">
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Requirements:

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  • Knowledge of science generally attained through studies resulting in a B.S; in biological science, Engineering, biochemistry, or related discipline, or its equivalent is preferred">
  • Advanced Level of relevant experience in a GMP, GCP, or GXP with at least 8 years focused on product quality">
  • Preferred Active member of ASQ or ISPE">
  • Prior experience of QC equipment Qualification and some project management experience">
  • Knowledge of biotech, bulk drug substance or finished product manufacturing, medical device analytical testing is highly desirable">
  • Extensive knowledge of US and EU cGMP regulations and guidance and GAMP 5">
  • Knowledge of electronic systems including any of the following: SAP, LIMS, TrackWise, Veeva Vault and electronic or paper-based batch records desirable">
  • Excellent Technical writing and oral communication skills are required">
  • Background in problem solving">
  • Knowledge of Data integrity principles">
  • Proven attention to details">
  • Comfortable working in an FDA regulated environment">
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Benefits

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We offer eligible employees 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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About You

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You will be a strategic thinker with excellent leadership skills, capable of driving results-oriented teams. Your extensive industry experience and technical expertise will help us drive quality and excellence in our operations.

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Your success will be measured by your ability to make informed decisions, build strong relationships, and drive business growth while maintaining compliance and regulatory standards.



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