Analytical Scientist/AQC Scientist/Quality Control

DescriptionWe are seeking a highly motivated and experienced Analytical Quality Control (AQC) Scientist to join our team. As an AQC Scientist, you will be responsible for performing quality control testing and release of materials, excipients, and products to ensure the safety and quality of sterile medicine manufactured by Selkirk. You will also support the commissioning and qualification of the analytical quality control laboratory, including execution of analytical instrument qualification and method validation protocols for testing governed by federal regulations as applicable in the pharmaceutical industry.About UsAt Selkirk Pharma, our mission is simple: we want to be the world’s most reliable manufacturer of injectable drug products. As an aseptic fill/finish contract manufacturer in Spokane, WA, every team member plays a critical role in helping us reach our vision of a world where safe and effective medication is accessible for every patient, every time it’s needed.What You’ll DoExecute test methods to certify the acceptability of raw materials, in-process products, or finished goods product for human use.Assist in the execution of validation activities for analytical instruments and methods. Assist with facility qualification activities as required.Actively work with colleagues and peers to foster and grow as part of a collaborative team member capable of analytical quality control.Work with colleagues and peers to maintain a culture of quality, efficiency, and continued intellectual growth.Assist in the drafting and review of SOPs, Specifications, Policies, and other documents as required. Assists in development and delivery of AQC training curricula.Identify and support relevant deviations per standard operating procedures.Develop strong working relationships at all levels of the organization.Ensure laboratories are maintained in an audit ready and cGMP compliant manner.Remain up to date on industry practices, trends, and regulations while sharing information with colleagues and drive change where warranted.We're Looking for Someone Who Has:AQC Scientist IBachelor’s degree in Chemistry, Biology, or other related scientific discipline or a combination of bachelor’s degree and pertinent, progressive experience in pharmaceutical industry.Experience in pharmaceutical quality control is desired.Familiarity with 21 CFR Part 210 and Part 211, and Part 11; FDA cGMP; Eudralex Volume 4 Annex 1; ICH; and other industry-related guidance documents is desired.Proficient in the use of Microsoft Office Suite including: Word, Excel, PowerPoint, and Outlook.Experience utilizing LIMS software, ERP software, and QMS software is desired.AQC Scientist IIBachelor’s degree in Chemistry, Biology, or other related scientific discipline.Three (3) years’ relevant experience in pharmaceutical industry.Knowledge of 21 CFR Part 210 and Part 211, and Part 11; FDA cGMP; Eudralex Volume 4 Annex 1; ICH; and other industry-related guidance documents.Proficient in the use of Microsoft Office Suite including Word, Excel, PowerPoint, and Outlook.Experience utilizing LIMS software, ERP software, and QMS software is desired.Other combinations of education and experience may be considered.What You’ll Love About UsCompany Culture:

Did someone say Taco Bar? As food fanatics, we like to find any reason to enjoy some good food together.Rest and Relaxation:

160 hours of PTO (pro-rated based on hire date), 52 hours of sick time (pro-rated based on hire date), and 10 paid holidaysHealth Benefits:

Medical with HSA and FSA options, dental, vision, LTD, and Life and AD&DPrepare for the Future:

Stock options and 401(k) with no vesting period (100% match on the first 3% and 50% on the next 2%)

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