Quality Control Analyst I

  • Anywhere

Company :
Partner Therapeutics

Location :
Lynnwood, Washington

Expiry Date :
Sat, 19 Dec 2020 23:59:59 GMT

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Description :
QC ANALYST I METHOD DEVELOPMENT Partner Therapeutics/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 being a cancer company begins and ends with the patient. We strive to support patients throughout their treatment journey and offer therapy options that are right for them and their loved ones. PTx has acquired worldwide rights to Leukine (sargramostim). As the only FD approved GM-CSF available in the U.S., we believe Leukine offers important and differentiated benefits to cancer patients and are excited by the opportunity to effectively re-introduce it to the oncology community with its current label and future expansion indications. Despite no commercial support for over a decade, Leukine is currently used in academic centers and group practices throughout the country. There is significant scientific interest in Leukine with over 100 ongoing ISTs. POSITION DESCRIPTION and OVERVIEW Quality Control Biological and Facilities Testing group supports manufacturing activities at the Northpointe Facility by detecting, quantifying and identifying possible contaminants that may interfere with the quality of the product during the different stages of the manufacturing process. The group supports the environmental and critical utility monitoring program of the production facility and support areas. The QC BFT group also performs key microbiological assays supporting BDS, cell bank and drug product release. The quality control method development laboratory is a support function for the QC BFT laboratory. The primary function of this laboratory is to develop and validate new methods, optimize existing methods, and oversee the transfer of methods. The department provides SME support for investigations and projects. This individual will report to the QC Scientist Senior and will contribute to the general BFT operations, as well as testing for the QC microbiology method development laboratory. The QC Analyst works independently under general supervision, and will participate with the QC team to meet group goals. KEY RESPONSIBILITIES LABORATORY TESTING AND SUPPORT * Performs standard QC test procedures and method development, data processing, and analysis in compliance with cGMP regulations. * Perform environmental monitoring and critical utility monitoring. * Support general housekeeping activities to maintain laboratory (washing glassware, autoclaving, routine equipment maintenance, etc). * Initiates, completes, and helps maintain GMP documentation (i.e. SOPs, laboratory investigations, change controls, deviations, etc) * Work with management to troubleshoot and problem-solve laboratory, method, instrument, or deviation issues or investigations * Review laboratory assay documentation for accuracy and timeliness. * Participate in the qualification of equipment, methods, and processes * Assist in the development and optimization of testing methods * Assist in ALCM method assessment and method trending * Ensure labs are clean and safe (in compliance with CGMP) and properly stocked * Provides testing support in method validations or method transfers. * Perform other additional job related duties, as required. COMPLIANCE * Adheres to department standard operating procedures. * Maintains an awareness, responsibility and accountability for current GMP and SOP requirements. * Follows safety precautions in the laboratory. * Documents any deviations. Partners with management to analyze and resolve deviations. * Follows Skills Inventory system to meet current training requirements per the established schedule and train on new procedures/requirements as required. * Prepares/revises laboratory SOPs, test methods, protocols and change control documentation in cooperation with QC Laboratory Management and Compliance departments. * Demonstrate flexibility, adaptability and initiative with changing priorities QUALIFICATIONS * BA/BS Degree in Microbiology, Biology, Chemistry, Biochemistry or related life sciences discipline. * Preferred 1+ years of directly relevant quality control experience in a regulated and relevant environment with experience working in a cGMP lab environment. * Proficient in Microsoft Office Suite. * Strong communication skills both written and verbally. * Must be able to lift 40lbs. * Must be able to perform aseptic gowning and gain entry to manufacturing areas * Must be available to work some Sundays and occasional holidays To be considered for this role, please send a CV or a resume (cover letter optional) to . This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform that may be required either now or in the future. Partner Therapeutics offers a competitive compensation/benefits package in a friendly, collaborative culture that values employee engagement and ongoing career development. Partner Therapeutics is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, sex, age, national origin, veteran status, marital status, sexual orientation, gender identity, disability or any other category prohibited by local, state or federal law. This policy applies to all aspects of employment, including recruitment, placement, promotion, transfer, demotion, compensation, benefits, social and recreational activities, and termination. Show moreShow less