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Quality Training Manager - Washington, United States - Selkirk Pharma
1 week ago
Description
Selkirk Pharma is seeking a proactive, quality-driven individual for our Quality Training Manager role.The right candidate has experience in Biotech/Pharma cGMP with an emphasis in a regulated training environment as this role supports the development of the Training program for purposes of compliance.
This position provides 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 role is highly collaborative, enabling you to put your educator and compliance skills to use.This is a great position for someone who enjoys working cross functionally to develop departmental training curricula and has acted as the administrator for an electronic learning management system.
This is anon-site,
full-time, exempt position, located in Spokane, WA.
Selkirk Pharma offers a comprehensive benefits package that includes medical, dental, vision, life, AD&D, and FSA for health and dependent care and 401k.
Selkirk Pharma offers vacation, sick, and parental leave. Please read more on the job tasks and requirements below. Qualified candidates should apply todayStarting /Hiring Wag
e:
$92,000 - $115,000 annually. See full list of benefits below for our complete compensation package.
Full Wage Rang
e:
$92,000 - $138,000 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.
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.
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.
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.
Requirements
Education and/or Experienc
e:
To perform this job successfully, an individual must hav
e:
Bachelor's degree in science or relevant field or equivalent experience.
Seven (7) 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 (ie:
FDA, EU, ICH, ISO), and handling of regulatory inspections.
Experience in technical writing background and reading/analyzing/interpreting common scientific/technical documents.
Excellent written/verbal communications with ability to influence effectively at all levels within organization.
Contract Manufacturing experience preferred.
Experience working with biologics preferred.
Computer Skills:
Proficient in the use of Microsoft Word, Excel, PowerPoint, Visio, MS Project and Outlook.
Experience utilizing software programs:
learning management systems (LMS), quality management systems (QMS),
FULL-TIME BENEFITS:
Medical (two medical plans offered)-PLAN 1: Company pays 90% of employee premiums; 75% of dependent premiums.
PLAN 2:
HDHP- Company pays 100% of employee premiums; 100% of dependent premiums.
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.
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.
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