Sr. MQC Scientist

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Job Type

Full-time

Description

We're looking for a Sr. MQC team to join our team! In this role, you will be primarily responsible for performing Microbiological testing and environmental monitoring of the facility. Other responsibilities include supporting analytical instrument qualification, method validation and troubleshooting, authoring and reviewing various types of documents, and maintaining laboratories in an audit ready and cGMP compliant manner.

About Us

At Selkirk, our mission is simple: we want to be the world's most reliable manufacturer of injectable drug products. As a new 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.

No matter your role at Selkirk Pharma, successful team members champion our values:

• Sincerity: We can work through anything if we are totally honest with ourselves and each other.

• Gratitude: So many good things come from gratitude: Dedication. Patience. Positivity. Kindness. We try to be actively grateful every day.

• Humility: To achieve greatness, we must be humble and self-aware in pursuit of our goals

• Enthusiasm: We intentionally bring an uncommon energy to every aspect of our work.

• Team: Our team is the nucleus around which everything else in our company is built.

What You'll Do

• Perform Microbiological testing and environmental monitoring activities as assigned.

• Accurately documents execution of testing and monitoring activities and reports results per appropriate procedures.

• Support execution of laboratory investigations for invalid, out-of-specification, and out-of-expectation results.

• Identify and handle deviations per standard operating procedures.

• Support implementation of CAPA action plans as assigned.

• Draw conclusions from data, observations, deviations and collaborate with other key stakeholders in other departments as necessary to implement resolutions.

• Develop, validate, and trouble shoot test methods to certify the acceptability of raw materials, in-process products, or finished good product for human use.

• Support commissioning and qualification of MQC equipment and systems, including writing protocols and acceptance reports, and protocol execution.

• Remain up to date on industry practices, trends, and regulations while sharing information with colleagues and recommend continuous improvement ideas.

• Draft, review, and approve procedures, specifications, forms, and other documents as required.

• As an MQC subject matter expert, may provide technical expertise to support operations with projects, investigations, risk assessments, audits or other ad hoc activities which require in-depth understanding of microbiology.

• Interact with clients and regulatory authorities in audits and discussions supporting the facility, manufacture of client owned products and commercialization of client owned products.

• Mentor junior level MQC Scientists to support their technical and professional development.

• Support a culture of safety by adhering to Selkirk safety policies and procedures and properly uses Personal Protective Equipment when required

• Develop strong working relationships through all levels of the organization.

We're Looking for Someone who Has:

• Bachelor's degree in Microbiology, Biology, or other related scientific discipline or a combination of bachelor's degree and pertinent, progressive experience in pharmaceutical industry.

• Five (5) years' experience in Microbiological Quality Control activities including instrument qualification and method validation activities.

• Two (2) years' GMP experience or regulated industry.

• Knowledge and experience in 21 CFR Part 210 and Part 211, and Part 11. Knowledge of FDA cGMP, GAMP 5, Eudralex Volume 4 Annex 1, USP, EP, and other industry related guidance documents.

• Mastery of microbiological test methods and best practices. High familiarity with isolate identification, bioburden testing, endotoxin analysis, sterility testing in isolator, and other microbiological assays required for sterile injectable drug product testing.

• Proficient with good documentation practices and general laboratory best practices.

• Experience participating in regulatory agency audits (FDA, EMA, ANVISA, PMDA, etc).

• Demonstrated ability to interact, communicate and collaborate effectively with colleagues, clients, auditors, regulatory representatives, and consultants.

• Proficient in the use of Microsoft Office Suite including: Word, Excel, PowerPoint, and Outlook.

• Experience utilizing LIMS software, ERP software, and QMS software.

This is an on-site, full-time, exempt position, located in Spokane, WA.

Hiring Wage: $79,000- $99,000 annually. See full list of benefits below for our complete compensation package.

Full Wage Range: $79,000-99,000 annually. Midpoint and above is reserved for employees who have longevity with Selkirk and consistently exhibit outstanding performance over a period of time in the role

Learn more about living in the beautiful PNW: https://www.visitspokane.com/

What You'll Love About Us

• Company 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 holidays

• Bereavement Leave: 5 days per event

• Expand your Family: Paid Maternity/Paternity Leave - 160 hours per occurrence

• Health Benefits: Medical with HSA and FSA options, dental, vision, LTD, and Life and AD&D

• Employee Assistance Plan: Counseling sessions, legal services, financial services, and more

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

• When Duty Calls: Jury Duty that is. We offer up to 10 days per event.

• Cell Phone Stipend: $10 per month