The Role
The Quality Control Scientist performs sample testing activities in the QC laboratory, adhering to GMP practices while ensuring timely client deliverables.
Summary Generated by Built In
Serán BioScience provides custom formulation, process development and clinical manufacturing services for a variety of pharmaceutical clients. Our Quality Control Department is seeking a Quality Control Scientist level I or II who performs and supports sample testing activities in the Quality Control laboratory, upholding GMP practices and timely completion of client deliverables.
Duties and Responsibilities
- Adheres to Standard Operating Procedures, cGMPs, Quality Manual, and company policies.
- Performs routine extractions for dissolution, assay, and impurities testing.
- Performs routine testing using analytical equipment including but not limited to KFC, dissolution apparatus, water activity, FTIR, etc.
- Conducts appearance testing, raw materials sampling, solution preparation, and pH measurements.
- 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.
- Conducts peer review of routine testing at the discretion of management.
- Performs hypothesis testing or investigative work for OOS results under management and SME guidance.
- Trains and mentors staff on established processes and procedures.
- Demonstrates cross-functional support capabilities with other QC teams.
- Adheres to consistent and predictable in-person attendance.
- Responsibilities may increase in scope to align with company initiatives.
Required Skills and Abilities
- Hands-on lab experience.
- Communicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside the Company.
- Follow detailed written and oral instructions.
- Demonstrated ability to collaborate and work in cross-functional teams.
- Strong organizational skills and attention to detail.
- Multitasks and adjusts priorities in a fast-paced environment, while maintaining focus and managing disruption and/or unexpected needs.
- Strong analytical and problem-solving skills.
- Accepts feedback from a variety of sources and constructively manages conflict.
- Ability to prioritize tasks and to keep leadership apprised of performance to timelines.
- Proficient with Microsoft Office Suite or related software.
Education and Experience
All levels: Bachelor’s degree in a scientific discipline or related field.
For a level I applicant, we are seeking 2 years of dedicated lab experience in addition to the science education. GMP setting experience not required but preferable.
For a level II applicant, we are seeking 3 years of dedicated lab experience (including 2 years in a GMP setting) in addition to the science education.
Benefits
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
Skills Required
- Bachelor's degree in a scientific discipline or related field
- 2 years of dedicated lab experience for level I
- 3 years of lab experience for level II, including 2 years in a GMP setting
- Hands-on lab experience
- Ability to communicate effectively
- Strong organizational skills and attention to detail
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The Company
What We Do
Serán Bioscience is a contract development and manufacturing organization (CDMO) that provides comprehensive pharmaceutical support for small and large molecule drug development. They offer services ranging from discovery to clinical manufacturing, including formulation design, spray drying, and analytical quality control, with a science-first approach aimed at helping clients advance medicines to the clinic efficiently.
