Senior Quality Assurance Lead Technical Operations Specialist

1 day ago


Devens, Massachusetts, United States Katalyst Healthcares & Life Sciences Full time

We are seeking a highly skilled Senior Quality Assurance Lead Technical Operations Specialist to join our team at Katalyst Healthcares & Life Sciences. As a key member of our organization, you will play a crucial role in ensuring the quality and compliance of our products.

About Us

Katalyst Healthcares & Life Sciences is a leading healthcare company dedicated to delivering innovative solutions for patients around the world. We are committed to excellence and strive to make a positive impact on people's lives.

Salary: $120,000 - $180,000 per year

This is a highly competitive salary range that reflects the value we place on your expertise and experience. Your compensation package will also include additional benefits and perks tailored to support your success.

Job Description

In this senior role, you will be responsible for providing quality assurance support to Devens Site and reporting managers through quality review and approval of Investigations and Corrective Actions. You will use your deep understanding of Quality Systems Regulatory expectations to make informed decisions regarding non-conformance.

You will review and approve Quality, Quality Control, Validation, and Automation related documents, as well as Standard Operating Procedures (SOPs) and Validation related documentation such as risk assessments, protocols, and test scripts. Your ability to coach across different departments and self-manage multiple competing deliverables will be essential to your success.

This position requires strong technical writing and oral communication skills, as well as a background in problem-solving and data integrity principles. You should be comfortable working in an FDA-regulated environment and have knowledge of electronic systems, including SAP, LIMS, TrackWise, Veeva Vault, and batch records.

Required Skills and Qualifications
  • Bachelor's degree in biological science, engineering, biochemistry, or a related discipline; equivalent experience considered.
  • Advanced level of relevant experience in GMP, GCP, or GXP with at least 8 years focused on product quality; preferred active membership in ASQ or ISPE.
  • Prior experience with QC equipment qualification and project management.
  • Knowledge of biotech, bulk drug substance, or finished product manufacturing, medical device analytical testing highly desirable.
Benefits

We offer a comprehensive benefits package that includes health insurance, retirement plans, paid time off, and professional development opportunities. Our commitment to employee well-being and career growth is unwavering.



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