Technical Writer II/III

Serán BioScience is searching for an experienced Technical Writer to support the Analytical Development team deliver accuracy and quality to clients within pharmaceutical development. The Technical Writer authors and reviews documents for Analytical Development and ensures GMP standards are implemented and executed. Examples of documents include protocols, reports, test methods, and SOPs. The selected candidate will work closely with Analytical Development managers to ensure that policies and procedures are followed as written and revised when necessary. Excellent communication skills and working industry knowledge are required, as this role will frequently communicate with clients, Project Management, Quality Assurance and other internal teams. Successful candidates will have at least two years of laboratory experience with a focus on document authoring and review, paired with at least three years of experience working within a GMP environment. Those with various educational backgrounds who have acquired the minimum requirements of industry experience are encouraged to apply.

• Write, revise, review, and approve SOPs, validation protocols, validations reports, and test methods
• Participate in audits and inspections
• Assist in forecasting and scheduling analytical validations with Project Management and Quality Control Management teams
• Conduct scientific/technical reviews of analytical validations, reports, test methods, and SOPs, as needed
• Authors investigations, CAPA’s Impact Assessments, Risk Assessments, Validation Discrepancy
• Reports, as required
• Adheres to consistent and predictable in-person attendance
• Responsibilities may increase in scope to align with company initiatives  
• All other duties as assigned

• Excellent verbal and written communication skills
• Excellent interpersonal and leadership skills
• Excellent organizational skills and attention to detail
• Communicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside the Company
• Excellent time management skills with a proven ability to meet deadlines and motivate teams
• Demonstrates the ability to collaborate and work in cross-functional teams
• Follow detailed written and oral instructions
• Multitasks and adjusts priorities in a fast-paced environment, while maintaining focus and managing disruption and/or unexpected needs
• Accepts feedback from a variety of sources and constructively manages conflict
• Proficient with Microsoft Office Suite or related software

• Bachelor’s degree in chemistry, physics, engineering, or related scientific discipline
• Requires 3 years of GMP experience
• At least 2 years of GMP laboratory experience; heavy focus on document authoring and review

• Prolonged periods of sitting at a desk and working on a computer
• Must be able to lift up to 25 pounds at times

Compensation correlates to skills and experience presented by selected candidate. Visit https://www.seranbio.com/careers to learn more about company culture and the community of Bend, Oregon.

Benefits Summary:

Serán employees accrue over four weeks of paid time off annually. Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period. Various health plans allow employees to find the best coverage for their individual or family needs with minimal employee contributions. Serán covers each employee with basic life and long-term disability, giving access to increase or add coverage. An Employee Assistance Program provides support for all things related to our employees’ wellbeing, along with access to pet insurance.

The Corporate Headquarters of Serán BioScience are located at 63047 Layton Ave, Bend, OR 97701