Senior Specialist, Quality Assurance

Resilience-posted 3 months ago
$70,000 - $115,000/Yr
Full-time • Mid Level
Chemical Manufacturing
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This position is responsible for all QA activities that directly support execution of the process both within the Operations Teams and in assigned areas outside of Operations. These activities may include, but are not limited to, batch release, change control and documentation, SOPs, supplier management, distribution center management, and regulatory interactions.

  • Maintain a high level of understanding of relevant production processes and quality systems.
  • Perform the QA review and approval of GMP documentation that has direct impact on the activities performed by, and facilities utilized in their corresponding areas.
  • Accountable for disposition (release or rejection) of semi-finished and finished packaged product.
  • Collaborate with and influence other Quality professionals across the organization to ensure consistent application and execution of key quality systems.
  • Execute QA processes including batch record review, product disposition, and quality issue resolution to maintain the flow of products and documents to meet site objectives.
  • Interface with applicable site support groups on projects that impact the Operations/assigned area, ensuring GMP compliance.
  • Collaborate in data analysis and report creation on quality metrics and key performance indicators.
  • Train and mentor junior members of the QA organization and provide QA coaching to other non-QA employees.
  • Prior experience in either the pharmaceutical industry, an operations environment, or Quality Assurance.
  • Strong demonstrated knowledge of cGMPs, Quality Systems, and the pharmaceutical supply chain environment.
  • Excellent oral and written communication skills.
  • Strong ability and motivation to learn.
  • Strong problem-solving skills.
  • Bachelor's degree or master's degree in quality assurance /regulatory affairs.
  • Previous experience in a Lean, process-centric organization with emphasis on continuous improvement.
  • Multi-site / multi-functional experience.
  • Annual cash bonus program.
  • 401(k) plan with a generous company match.
  • Healthcare benefits including medical, dental, and vision.
  • Family building benefits.
  • Life and disability insurance.
  • Flexible time off.
  • Paid holidays.
  • Other paid leaves of absence.
  • Tuition reimbursement.
  • Support for caregiving needs.
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