QA PRODUCT RELEASE COMPLIANCE SPECIALIST SENIOR

 

PTx is devoted to developing and commercializing cancer medicines and combination therapies that can make a meaningful difference in the lives of cancer patients. We are united in our passion for improving the treatment of cancer and our desire to make a meaningful contribution to outcomes. We believe that innovation is not enough. In today’s challenging healthcare climate, we strive to develop and assess our products based on the real-world impact they have in improving the quality and duration of our patients’ lives. We measure our success in the birthdays, anniversaries, and other important life moments that our patients are able to enjoy.

 

PTx has recently acquired global rights to Leukine (Sargramostim). Leukine is the only licensed FDA-approved GM-CSF, and PTx is investing in Leukine to position it for growth. With Leukine, PTx acquired its state-of-the-art manufacturing facility in Lynnwood and we are North of Seattle, just a few minutes from downtown (but far enough out of, traffic and high cost of living in the city!). We are an established team with a renewed energy to seize on an exciting opportunity. To get there we need outstanding people to join our team of talented, innovative and committed professionals.

 

The QA Product Release Compliance Specialist Senior helps ensure the safety, efficacy, purity, and quality of manufactured products through compliance with cGMPs, regulations and established procedures. The position supports raw material disposition, product disposition, product complaints and the periodic product review. NO DIRECT REPORTS.

 

POSITION OVERVIEW/KEY RESPONSIBILITIES:

  • Assess documentation for GMP compliance and product quality issues.

  • Review and support the disposition Raw Materials, Bulk Drug Substance (API), Drug Product and Finished Product

  • Contribute to the GxP oversight of Contract Manufacturing Organizations and business partners involved in the manufacture, testing, and transport of products

  • Ensure processes align with current good manufacturing practices and industry practices/regulatory requirements

  • Support the Product Complaint program

  • Maintain compliance requirements for established quality system programs

  • Assemble information for the Periodic Product Review and support the preparation of the annual PPR report                                     

  • Participate in investigation teams and teams to support the management of change control

 

BASIC QUALIFICATIONS:

  • Bachelor’s degree in Science and 6 years of experience in a cGxP or other regulated environment, to include 3+ years in a Quality role

  • Knowledge of FDA regulations and experience in commercial biologic product disposition

  • Proficiency in Microsoft PowerPoint, Word, Excel, and databases

  • Strong written and verbal communication skills

 

PREFERRED QUALIFICATIONS:

  • Experience with disposition of biologic bulk drug substance, drug product and raw materials

  • Product Complaint experience

  • Annual product review experience

 

Compensation and benefits are very competitive. They include a base salary, performance bonus, stock options and profit sharing. Our benefits include health, vision, dental and life INS, 401(k) with match & PTO

 

To be considered for the position, please send your resume to Brooklyn.borges@partnertherapeutics.com

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Lexington, MA 02421

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