Sr. QA Compliance Specialist

DescriptionThis position is primarily responsible for adherence to defined timelines as related to the development, support and execution of Quality Assurance Supplier Quality and Compliance programs/governing procedures. This includes management and execution of programs such as supplier quality management, quality agreements, internal audits, client/regulatory audits, management review, quality risk management, and driving site inspection readiness. Secondary support with execution of Selkirk’s regulatory strategy may be required. This role works closely with all functions across the organization and parallel quality functions.About UsAt 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 goalsEnthusiasm:

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 DoManage and execute the Supplier Quality program by conducting external audits, evaluating supplier risk assessments, complaints and change notifications, and/or associated approvals. Establishes and maintains requalification schedule and updates approved supplier database.Manage and execute the Compliance program by conducting internal audits, hosting client audits and regulatory inspections, and leading / supporting management review and risk management.Manage and execute site inspection readiness by conducting preparation sessions, mock inspections, developing and maintaining storyboards, and management of compliance data.Develop, plan, and conduct internal audits of Selkirk’s functional areas ensuring compliance to regulatory requirements, expectations and internal processes and programs, write audit reports, review and track corrective actions and audit closures with escalation as necessary. Establishes and maintains internal audit schedule.Serve as a cGMP consultant to internal and external clients and provides researched and supported opinions on complex compliance issues which will provide guidance to less experienced staff members.Manage, support, and participate in regulatory agency inspections and client audits and lead cross functional teams to develop responses to observations and track the commitments to completion.Support quality functions including Deviations, CAPAs, Change controls, development of key performance indicators, and continuous improvement initiatives.Work cross functionally with all functional areas and provides support and guidance to ensure the site meets applicable global regulatory, cGMP and company requirements.Support execution of Selkirk’s regulatory strategy including Compliance, Operations, and Surveillance functions.We’re Looking for Someone who Has:Bachelor’s degree in science or relevant field.Seven (7) years’ related experience in Quality Unit functions within a government regulated industry (FDA pharmaceutical manufacturing environment preferred), or an equivalent combination of education and experience.Experience developing, executing, and managing Supplier Quality and Compliance programs.Experience facilitating client and regulatory inspections, inspection readiness, and development and tracking of responses and commitments to regulatory observations.Extensive knowledge of industry guidelines including cGMP and regulatory guidelines (i.e. FDA, EU, ICH, ISO).Experience in quality of aseptic processes Grade A through Grade D production areas and knowledge of isolation technology with filling operations experience highly desired.Professional ASQ Certified Quality Auditor certification preferred, or willingness to obtain.Proficient in the use of Microsoft Office Suite including Word, Excel, PowerPoint, and Outlook.Experience utilizing QMS software preferred, such as Trackwise, Master control, Vevva, etQ Reliance, Dot Compliance.Working knowledge of Virtual Manufacturing Software preferred, such as ModaES, Master Control, Syncade, Detla V, and Electronic Batch Records.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 - 119,000 annually. Midpoint and above is reserved for employees who have longevity with Selkirk and consistently exhibits outstanding performance over a period of time in the roleWhat 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 holidaysBereavement Leave:

5 days per eventExpand your Family:

Paid Maternity/Paternity Leave – 160 hours per occurrenceHealth Benefits:

Medical with HSA and FSA options, dental, vision, LTD, and Life and AD&DEmployee Assistance Plan:

Counseling sessions, legal services, financial services, and morePrepare 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

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