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

Serán BioScience • Bend, OR

4d • Onsite

About The Position

Serán BioScience is hiring a scientist to support pharmaceutical drug-product manufacturing in its In-Process Control group. The role works with scientists and operators in the Quality Control department to help ensure product quality by testing raw materials and production equipment in GMP manufacturing and laboratory environments. Candidates should have laboratory experience and be able to use specialized laboratory equipment, techniques, and methodologies for technical assessments and data analysis. GMP experience and pharmaceutical-industry technical data review experience are preferred. The role may expand in scope to align with company initiatives.

Requirements

• Bachelor's degree in a related scientific discipline.
• At least 3 years of hands-on laboratory experience.
• At least 2 years of GMP experience to be considered for Scientist II.
• Hands-on laboratory experience with HPLC, GC-HS, TOC, and FT-IR.
• Hands-on laboratory experience with raw-material testing.
• Strong verbal and written communication skills.
• Ability to collaborate and work in cross-functional teams.
• Strong organizational skills and attention to detail.
• Ability to follow detailed written and oral instructions.
• Strong time-management skills and ability to meet variable and competing deadlines.
• Strong analytical and problem-solving skills.
• Ability to communicate effectively and maintain productive relationships with coworkers, clients, and other external contacts.
• Ability to multitask and adjust priorities in a fast-paced environment while maintaining focus and managing disruptions or unexpected needs.
• Ability to accept feedback from a variety of sources and constructively manage conflict.
• Ability to prioritize tasks and keep leadership informed about performance against timelines.
• Ability to function in a high-paced and sometimes stressful environment.
• Proficiency with Microsoft Office Suite or related software.
• Ability to lift up to 25 pounds at times.
• Motor skills required for basic laboratory operations.
• Predictable in-person attendance.

Nice To Haves

• GMP experience is preferred.
• Experience with technical data review in the pharmaceutical industry is preferred.

Responsibilities

• Adhere to Standard Operating Procedures, cGMPs, the Quality Manual, and company policies.
• Perform routine testing using analytical equipment, including HPLC, GC, KFC, and dissolution equipment.
• Conduct appearance testing, solution preparation, raw-material sampling, and pH measurement.
• Draft stability tables, set up stability studies, and log in samples and standards.
• Clean the laboratory and glassware, and dispose of analytical waste appropriately.
• Participate in process improvement and other non-routine projects.
• Enter clean spaces wearing appropriate PPE to collect samples.
• Conduct peer reviews of routine testing at the discretion of the relevant supervisor.
• Prepare technical writing and reports, including incident reports, laboratory investigations, CAPAs, SOPs, trend reports, and risk assessments.
• Perform hypothesis testing or investigative work for OOS results under management and subject-matter-expert guidance.
• Provide cross-functional support to other QC teams.
• Perform other related duties as assigned.

Benefits

• More than four weeks of paid time off accrued annually.
• Employer retirement-account contributions begin after 90 days and require no employee match or vesting period; the posting also describes a 5% 401(k) contribution.
• Health plans with minimal employee contributions.
• Basic life and long-term disability coverage, with the option to increase or add coverage.
• Employee Assistance Program.
• Access to pet insurance.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level