Quality Assurance Specialist II/III

Serán BioScience • Bend, OR

2d • Onsite

About The Position

Serán is seeking a Quality Assurance Specialist to support the daily activities of its Quality Assurance department and GMP clinical manufacturing operations. The role reviews and approves raw material and production records, investigations/CAPA, and change controls. It also provides support on the manufacturing floor and contributes to the continuous improvement of quality processes. Responsibilities may increase in scope to align with company initiatives.

Requirements

• Knowledge of GMP, FDA, and EMA regulations for clinical drug manufacturing.
• Knowledge of change control procedures, CAPA programs, investigations, 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 and a proven ability to meet deadlines.
• Strong analytical and problem-solving skills.
• Ability to prioritize tasks.
• Proficiency with Microsoft Office Suite or related software.
• Ability to communicate effectively and maintain productive relationships with coworkers, clients, and external contacts.
• At least 3 years of GMP manufacturing or QA experience.
• Must be authorized to work for an employer in the U.S.; Serán is unable to sponsor or take over sponsorship of an employment visa.

Nice To Haves

• Bachelor’s degree in a scientific discipline.

Responsibilities

• Implement and continuously improve the company’s quality systems.
• Author, review, and approve SOPs and associated documents.
• Review and approve master batch records.
• Review and release raw materials and products.
• Oversee, review, and approve investigations, CAPA, and change controls.
• Contribute to a culture of quality ownership, compliance, and continuous improvement.
• Communicate quality-related information to internal teams with guidance and recommendations.
• Support internal audits, client audits, and regulatory inspections as needed.
• Perform other duties as assigned.

Benefits

• Employees accrue over four weeks of paid time off annually.
• Employer contributions to a retirement account begin after 90 days and require no employee match or vesting period.
• Various health plans are available with minimal employee contributions.
• Basic life and long-term disability coverage, with the option to increase or add coverage.
• Employee Assistance Program for wellbeing support.
• Access to pet insurance.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed