Quality Assurance Specialist II/III

About the role

Seran is seeking a Quality Assurance Specialist to support the daily activities of Serán's Quality Assurance department supporting GMP clinical manufacturing operations. This individual will be responsible for reviewing and approving raw material records, production records, investigations/CAPA, and change control. Additional responsibilities include manufacturing floor support and continuous improvement of quality processes.

Duties & Responsibilities

• Implementation and continuous improvement of the company's quality systems.
• Documents authorship, review, and approval of SOPs and associated documents.
• Reviews/approves master batch records
• Raw material and product review and release.
• Oversight, review, and approval of investigations, CAPA, and change controls.
• Contributes to a culture of quality ownership, compliance, and continuous improvement
• Communicates quality-related information to internal team with guidance and recommendations.
• Supports of internal audits, client audits and regulatory inspections, as needed.
• All other duties as assigned.
• Responsibilities may increase in scope to align with company initiatives.

Required Skills & Abilities

• Knowledge of GMP, FDA, and EMA regulations for clinical drug manufacturing.
• Knowledge of change control procedures, CAPA program, investigation, root cause analysis, and good documentation practices.
• Demonstrated ability to collaborate and work in cross-functional teams
• Excellent verbal and written communication skills.
• Excellent interpersonal and customer service skills.
• Excellent organizational skills and attention to detail.
• Excellent time management skills with a proven ability to meet deadlines.
• Strong analytical and problem-solving skills.
• Ability to prioritize tasks.
• Proficient with Microsoft Office Suite or related software.
• Communicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside the company.

Education & Experience

• Bachelor's degree in a scientific discipline preferred.
• 3+ years GMP manufacturing or QA experience.

Physical Requirements

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

Additional information

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