Quality Control Scientist I/II, In-Process Control- Day Shift

United States·BendFull-time Exemptmid

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Quick Summary

Requirements Summary

incident reporting, laboratory investigations, CAPAs, SOPs, trend reports, risk assessments, etc.

Technical Tools

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Serán BioScience is looking for a scientist with laboratory experience to support manufacturing of pharmaceutical drug products within our In-Process Control group. As a scientist within the Quality Control department you will work alongside a team of scientists and operators to ensure the highest quality product by testing raw materials and production equipment within GMP manufacturing and laboratory environments. Qualified candidates will demonstrate expertise in utilizing specialized laboratory equipment, techniques, and methodologies for technical assessments and data analysis purposes. Preference will be given to those with experience in GMP environments and technical data review specific to the pharmaceutical industry.

Serán BioScience develops and manufactures novel drug products for a variety of pharmaceutical applications. We aim to build a workforce that is collaborative, creative, and kind. In addition to the skills required of the role, qualified candidates will approach their work with integrity and enthusiasm to promote a positive work culture. Employees are awarded generous PTO accrual, low-cost health benefits, and a 5% 401(k) contribution that does not require an employee match or vesting. Want to learn more about what we do, who we are, and how you can contribute? We look forward to seeing your application.

Adheres to Standard Operating Procedures, cGMPs, Quality Manual, and company policies

Performs routine testing using analytical equipment including but not limited to HPLC, GC, KFC, Disso, etc.

Conducts appearance testing, solution preparation, raw material sampling, and pH measurement

Drafts stability tables, sets-up stability studies, logs-in samples and standards

Cleans lab and glassware and disposes of analytical waste appropriately

Participates in process improvement and other non-routine projects

Enters clean spaces with appropriate PPE to collect various samples

Is familiar with introductory analytical equipment (e.g., HPLC, GC-HS, TOC, FT-IR)

Is familiar with raw materials testing requirements (compendial and client testing)

Conducts peer review of routine testing at the discretion of the relevant supervisor

Performs technical writing and reporting including but not limited to: incident reporting, laboratory investigations, CAPAs, SOPs, trend reports, risk assessments, etc.

Performs hypothesis testing or investigative work for OOS results under management and SME guidance

Demonstrates cross-functional support capabilities with other QC teams

Responsibilities may increase in scope to align with company initiatives

All other related duties as assigned

Hands-on lab experience in HPLC, CG-HS, TOC, FT-IR

Hands-on lab experience with raw materials testing

Strong verbal and written communication skills

Demonstrated ability to collaborate and work in cross-functional teams

Strong organizational skills and attention to detail

Follows detailed written and oral instructions

Strong time management skills with a proven ability to meet variable and competing deadlines

Strong analytical and problem-solving skills

Communicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside the Company

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

Ability to prioritize tasks and to keep leadership apprised of performance to timelines

Ability to function well in a high-paced and at times stressful environment

Proficient with Microsoft Office Suite or related software

Bachelor's degree in related scientific discipline

3 years of hands-on laboratory experience required, cGMP preferred

Minimum of 2 years of GMP experience required to be considered for Scientist II

Prolonged periods of sitting or standing at a desk and working on a computer

Prolonged periods of sitting or standing in laboratory environment

Must be able to lift up to 25 pounds at times

Adheres to predicable in-person attendance

Motor skills required for basic laboratory operations

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.

Applicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

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