- Spokane, WA, USA
- Full Time
Selkirk Pharma invites employees to participate in a comprehensive benefits package that includes medical, dental, vision, life, AD&D, and FSA for health and dependent care and retirement plans.
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 an aseptic fill finish Contract Manufacturing Organization (CMO) designed specifically for the manufacture of parenteral drugs. The Technical Documentation Specialist is responsible for initiating the development of technical documents such as Standard Operating Procedures (SOPs), URS's (User Requirements Document), and the review of documents for improvement for the Engineering and Maintenance/Metrology departments. This role will work with all staff in the facility to ensure the Engineering and Maintenance/Metrology department's documents are well defined, understood and continue to evolve to reflect Selkirk's strategic direction. The successful candidate must be ethical, principled, knowledgeable, and adaptable.
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:
- Draft and revise Standard Operating Procedures associated with Engineering and Maintenance/Metrology operations within the electronic documentation system.
- Draft User Requirements Documents.
- Gather information from technical documents/documentation and/or other resources and develop Standard Operating Procedures and User Requirements Documents.
- Responsible for understanding the proper use of engineering and maintenance documentation.
- Address comments as provided by document reviewers.
- Leverage best practices and provide expertise to technicians and support groups, when reviewing draft SOPs and Form Preps.
- Coordinate with the Department Manager to ensure appropriate training materials are created with new or revised GMP documentation.
- Complete action items within the document management system prior to the due date.
- Support continuous improvement efforts to ensure documentation is efficient and compliant.
- Establish and maintain relationships with Engineering and Maintenance/Metrology staff and serve as a point of contact and expertise for developing high quality written documentation.
- Collaborate with Engineering and Maintenance/Metrology personnel to develop and execute written procedures necessary to maintain the facility in compliance with 21CFR210, 21CFR211, and 21CFR11.
To perform this job successfully, an individual must meet the minimum qualifications listed below. These qualifications are representative of the knowledge, skill and/or ability required to perform this job.
Education and/or Experience: To perform this job successfully, an individual must have:
- Minimum of 3 years related experience in Technical Writing or an equivalent combination of education and experience.
- Experience with GMP requirements preferred.
- An understanding of mechanical, electrical and control systems is a plus.
- Proficient in the use of (Microsoft Office Suite including: Word, Excel, PowerPoint, and Outlook.)
- Experience with technical documentation processes and CFR requirements.
- Working knowledge of electronic documentation systems, such as DOT Compliance, QAD and Blue Mountain Regulatory Asset Manager is a plus.
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. As a condition of employment, proof of full COVID-19 vaccination series is required.
Selkirk Pharma is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
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.