QA PRODUCT RELEASE COMPLIANCE SPECIALIST

 

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 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 for this role.

 

POSITION OVERVIEW/KEY RESPONSIBILITIES:

  • Assess documentation for GMP compliance and product quality issues

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

  • Monitor manufacturing compliance via documentation review

  • Maintain compliance requirements for established quality system programs

  • Manage document change requests as assigned

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

  • Support the Product Complaint program                                  

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

  • Support regulatory inspections

 

DELIVERING TO CUSTOMERS:

  • Understand patient and customer needs and build relationships as required to meet manufacturing goals.  They create a vision for the organization while continuously improving operations by holding teams accountable to high standards of performance.

 

BASIC QUALIFICATIONS:

  • Bachelor’s degree in Science and 3-5 years of experience in a cGxP or other regulated environment, preferably in a Quality role

  • Knowledge of FDA regulations

  • 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

  • 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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