Quality Control Scientist II (Alternative Shift)

@ Serán BioScience

Quality Control Scientist II (Alternative Shift)

Posted today

About the job

Serán BioScience specializes in biopharmaceutical manufacturing. The QC Scientist II supports testing functions, focusing on in-process control lab methods, cGMP compliance, and process improvement within a dynamic environment.

Requirements

Proven analytical instrumentation experience
Strong organizational skills
Experience with Empower software
Ability to work in fast-paced environment
Effective communication skills

Qualifications

Bachelor’s degree in sciences
Minimum 3 years lab experience
2 years GMP experience
Proficient in MS Office
Cross-functional collaboration skills

Full job description

Serán BioScience is searching for an experienced Quality Control Scientist II to support an extended manufacturing schedule. This role would support all testing functions for Quality Control, primarily focused on in-process control lab methods to ensure manufacturing excellence. The Scientist II needs to exhibit experience and confidence within a cGMP laboratory with proficiency in analytical equipment operations and data record management.

The preferred schedule of this role is 11:00 am - 8:00 pm Monday - Friday. Specific schedule is negotiable in support of manufacturing swing shift operations.

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
Responsibilities may increase in scope to align with company initiatives
Performs other related duties as assigned

Required Skills and Abilities

Proven analytical instrumentation experience (preferably HPLC) with at least 1-2 years in a cGMP pharmaceutical industry laboratory
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
Experience with Empower preferred
Proficient with Microsoft Office Suite or related software

Education and Experience

Bachelor’s degree in a scientific discipline or related field
Minimum of 3 years of dedicated lab experience
Requires 2 years of GMP experience

Physical Responsibility

Prolonged periods of sitting or standing at a desk and working on a computer.
Prolonged periods of standing or sitting while monitoring laboratory equipment.
Must be able to lift up to 15 pounds at times.
Adheres to consistent and predictable in-person attendance.

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

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