QUALITY CONTROL ANALYST I and II-RAW MATERIAL - PHARMA TESTING - CONTRACT 

 

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.

 

This position is responsible for the performance of standard quality control assays that may include in-process and release testing.  Additionally, this position is responsible for the timely performance of supporting laboratory functions, data processing, and documentation functions in compliance with procedures and cGMP regulations.

 

POSITION OVERVIEW/KEY RESPONSIBILITIES:

LABORATORY TESTING AND SUPPORT                                                             (75%)

 

  • Provides testing support for the release of raw materials

  • Provides testing support for the release of bulk drug substance and drug product

  • Provides testing support for the development of new quality control test methods

  • Provides testing support in method validations or method transfers

  • Performs standard QC procedures, data processing, and analysis in compliance with cGMP regulations

  • Assists in the qualification of critical reagents and instruments

  • Maintains inventory of critical reagents, chemical reagents and laboratory supplies

  • Provides efficient, effective and timely analytical support to both internal and external customers while prioritizing activities as necessary to meet the work schedule deadlines

  • Maintains laboratory, including, but not limited to: washing glassware, preparing buffers, and helping perform routine maintenance on equipment and instruments

  • Initiates, completes, and helps maintain GMP documentation (SOPs, laboratory investigations, change controls, deviations, etc)

  • Performs data entry and data review to support product release

  • Demonstrates skills in relevant scientific methodologies with some troubleshooting abilities

  • Partners with Engineering for instrument qualification and validation activities and performs special projects as required regarding various technical issues

  • Troubleshoots instruments and takes appropriate corrective actions to make sure laboratory instruments are qualified and validated

  • May cross-train in other areas within the Quality Control department

 

 

COMPLIANCE                                                                                                          (25%)

 

  • Maintains an awareness, responsibility and accountability for current GMP and SOP requirements

  • Follows safety precautions in the laboratory

  • Investigates and documents any deviations

  • Follows current training requirements per the established schedule and train on new procedures/requirements as required

  • Prepares and/or reviews laboratory SOPs, test methods, protocols and change control documentation in collaboration with QC Laboratory Management and Compliance departments

  • Maintains an awareness, responsibility and accountability for current GMP and SOP requirements

  • Partners with Supervisor to analyze and resolve investigations

  • Recognizes patterns/trends and proposes solutions to improve compliance

 

 

BASIC QUALIFICATIONS:

  • BA/BS Degree; Chemistry/Biochemistry

  • Minimum of 3 years of QC Chemistry/Analytical Lab experience preferable

 

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 Justin.Hoeker@partnertx.com

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