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.
\n Duties and Responsibilities Write, revise, review, and approve SOPs, validation protocols, validations reports, and test methodsParticipate in audits and inspectionsAssist in forecasting and scheduling analytical validations with Project Management and Quality Control Management teamsConduct scientific/technical reviews of analytical validations, reports, test methods, and SOPs, as neededAuthors investigations, CAPA's Impact Assessments, Risk Assessments, Validation DiscrepancyReports, as requiredAdheres to consistent and predictable in-person attendanceResponsibilities may increase in scope to align with company initiatives? All other duties as assigned Required Skills and AbilitiesExcellent verbal and written communication skillsExcellent interpersonal and leadership skillsExcellent organizational skills and attention to detailCommunicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside the CompanyExcellent time management skills with a proven ability to meet deadlines and motivate teamsDemonstrates the ability to collaborate and work in cross-functional teamsFollow detailed written and oral instructionsMultitasks and adjusts priorities in a fast-paced environment, while maintaining focus and managing disruption and/or unexpected needsAccepts feedback from a variety of sources and constructively manages conflictProficient with Microsoft Office Suite or related software Education and ExperienceBachelor's degree in chemistry, physics, engineering, or related scientific disciplineRequires 3 years of GMP experienceAt least 2 years of GMP laboratory experience; heavy focus on document authoring and review Physical Requirements Prolonged periods of sitting at a desk and working on a computerMust be able to lift up to 25 pounds at times
\nCompensation 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.