COMPANY DESCRIPTION:

Selkirk Pharma is a new aseptic fill/finish contract manufacturer of sterile injectable products, located in Spokane, Washington. Every member of our highly dedicated team plays a critical and visible role in helping to manufacture and deliver life-saving drugs to patients. Our shared values of sincerity, gratitude, enthusiasm, humility and team guides us and enables us to deliver upon our vision of a world where safe and effective medication is accessible for every patient, every time it’s needed. At Selkirk, we enjoy our work, appreciate where we live and are grateful for the opportunity to be part of an industry that makes a difference in people’s lives.

Selkirk Pharma is looking for a Quality Training Manager to join our growing team. The right candidate has experience in Biotech/Pharma cGMP with an emphasis in a regulated training environment. This role will develop the quality training function as well as author, execute, and update governing training standard operating procedures (SOPs). If you are able to work cross functionally to develop departmental training curricula and have acted as the administrator for an electronic learning management system, and have developed training related Key Performance Indicators (KPIs), please read more regarding the role below. Qualified candidates should apply today!

Starting /Hiring Wage: $92,483 - $115,603 annually

See full list of benefits below for our complete compensation package.

Full Wage Range: $92,483 - $138,724 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.

POSITION SUMMARY:

This position is responsible for supporting the development of the Training program for purposes of compliance. This position will be responsible for providing personnel GMP qualification and training activities, including supporting SME’s in the development of training plans/curricula which define document, classroom, computer-assisted, or proficiency training required for personnel to execute their assigned duties. This position functions as an administrator for the digital learning management system within the electronic Quality Management System (eQMS). This role will be responsible for monitoring and reconciliation of completed training, as well as oversight of the development and provision of annual GMP/GDP training for all Selkirk personnel.

KEY or ESSENTIAL FUNCTIONS:
To perform this job successfully, an individual must be able to satisfactorily perform each of the essential duties/responsibilities listed below. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties/responsibilities of this job. The essential functions of the position include but are not limited to the following:

• Develops the Quality Training function, in support of the Pharmaceutical Quality System (PQS), for Selkirk.
• Works cross functionally with Selkirk Stakeholders to define phase appropriate scalable processes to support compliance related training needs.
• Authors, executes, and updates governing Training standard operating procedures (SOPs) to ensure compliance and good practices.
• Develops and provides annual GMP/GDP training content (e.g., consistent training plans for new hire GMP/GDP training, on-the-job training, compliance, etc.) for Selkirk.
• Works cross functionally with Selkirk Stakeholders to ensure training curricula are reviewed and approved for all job specific functions , and are properly assigned within the eQMS.
• Supports the Selkirk Training Program Manager with training activities of Selkirk personnel. This includes routine provision of learning management system training during new employee orientation.
• As Selkirk continues to grow, will eventually build, manage, and develop a team of Quality Training Specialists.
• Supports Quality Operation organization as necessary, including assisting with audits, regulatory inspections, procedure development, etc.
• Supports the development and reporting of Training related Key Performance Indicators (KPIs), which may include measurement of training effectiveness.
• Manages training related investigations and associated Corrective and Preventive Actions (CAPA).
• Stays well-informed of current regulatory and industry developments and standards sharing with teams as appropriate.

JOB REQUIREMENTS

Education and/or Experience: To perform this job successfully, an individual must have:

• Bachelor’s degree in science or relevant field or equivalent experience.
• 7 – 10 years’ applicable experience in Biotech/Pharma cGMP manufacturing environment required, with an emphasis in a regulated training environment being preferred.
• Working knowledge of industry guidelines including cGMP, regulatory guidelines (i.e.: FDA, EU, ICH, ISO), and handling of regulatory inspections.
• Experience with learning management software, or equivalent, required.
• Demonstrated ability to analyze, investigate and propose approaches to quality and regulatory issues.
• Technical writing background; able to read/analyze/interpret common scientific/technical documents.
• Solid judgment and decision making in complex situations.
• Highly ethical and transparent, with professional sensitivity and care for confidentiality.
• Excellent written/verbal communications with ability to influence effectively at all levels within organization.
• Prior Contract Manufacturing experience desired.
• Experience working with biologics desired.

Computer Skills:

• Excellent MS Office (Word, Microsoft Excel, and Power Point) required. Presentation skills required.

FULL-TIME BENEFITS:

• Medical, Dental and Vision - Company pays 90% of employee premiums; 75% of dependent premiums
• Company provided Basic Life & AD&D Insurance
• Voluntary Life & AD&D available for an employee to add additional coverage for themselves and dependents
• Voluntary Long-Term Disability available
• Employee Assistance Plan
• Flexible Spending Account: Health Care Reimbursement & Dependent Care Reimbursement
• Stock Options
• Vacation available– up to 160 hours per year, pro-rated based on hire date
• Sick leave available– up to 52 hours per year, pro-rated based on hire date. Additional leave based on overtime for non-exempt employees
• Bereavement Leave – 5 days per event
• Emergency Leave – 2 days per year, pro-rated based on hire date
• Parental Leave / Maternity and Paternity Leave – 160 hours per occurrence
• Jury Duty – up to 10 days per event
• Paid Company Holidays (major holidays)
• Cell Phone Stipend – $10 per month
• 401k Plan: Company Safe Harbor Matching Contributions equal to 100% of your contribution up to 3% and 50% of your contributions from 3-5%

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.