QA Operations & Inspection Specialist

Description

We’re seeking a QA Operations & Inspections Specialist to join our team! In this position, you will be responsible for performing QA on the floor inspections, raw material receipt and release, sampling inspections of filled vial products. The right individual posses a quality mindset, the eye for detail and to perform all tasks with integrity. This is an on-site, full-time, non-exempt position, located in Spokane, WA.

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

• Conduct inspection activities to determine product acceptance of components while assuring compliance with written procedures: visual inspection, sampling per inspection plan requirements, master set test kits.
• Conducts material receipt inspection and release while assuring compliance with written procedures: performs sampling, review of COAs, utilizes the ERP system
• Conduct QA on the floor activities while assuring compliance with written procedures: area clearance of GMP areas, audit manufacturing processes including documents and batch reviews. Handles deviations and assists in investigations.
• Perform job functions in compliance with established work instructions and adherence with SOPs.
• Read and interpret specifications and/or component prints.
• Ensure calibration and maintenance is performed on inspection equipment.
• Report any Non-Conforming Materials/Processes.
• Provide knowledge and expertise for the department.
• Work with the Quality Unit and Supply Chain to resolve issues in materials received from suppliers.
• Assist with facility qualification activities as required.
• Remain up to date on industry practices, trends, and regulations while sharing information with colleagues and drive change where warranted.
• Draft and reviews SOPs, Specifications, Policies, and other documents as required.
• Develop strong working relationships throughout all levels of the organization.
  
  

Requirements

Role Requirements & Compensation

Specialist I: Hiring range $25.00 – 29.00 per hour. Full range: $25.00 - $31.00 per hour.

• Associate degree in science or related field, or High School diploma or a General Education Degree with 2 years equivalent experience.
• Two (2) years related experience in a Biotech/Pharma cGMP Manufacturing / Quality Operations or regulated environment preferred.
• 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 preferred.
• Proficient in the use of Microsoft Office Suite including Word, Excel, PowerPoint, and Outlook.
• Experience utilizing ERP, EAM and QMS software preferred.
• One (1) years’ experience vial inspection is preferred.
  
  

Specialist II: Hiring range $29.00 – 36.00 per hour. Full range: $29.00 – 43.00 per hour

• Associate degree in science or related field, or High School diploma or a General Education Degree with 2 years’ equivalent experience.
• Five (5) years’ related experience in a Biotech/Pharma cGMP Manufacturing / Quality Operations environment.
• Two (2) years’ experience vial inspection.
• Knowledge and experience in 21 CFR Part 211. Knowledge of FDA cGMP, GAMP 5, Eudralex Volume 4 Annex 1, USP, EP, and other industry related guidance documents.
• Proficient in the use of Microsoft Office Suite including Word, Excel, PowerPoint, and Outlook.
• Experience utilizing ERP, EAM and QMS software.
  
  

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
  
  

How To Apply

If you meet our qualifications and you are motivated by working in a highly energetic, collaborative environment, we invite you to apply for this position. We invite you to apply for this position no matter what your identity is; you will be welcome here.

All qualified individuals will receive consideration for employment. We are an equal opportunity employer.

Selkirk does not engage with recruitment services. All resumes / cover letters / applications / etc. sent to Selkirk are considered a direct application without representation. Selkirk does not compensate for recruitment services.