Quality Assurance Associate II/III

Seranbio; Bend (OR); On-site; USD 60,000 - 80,000; Full time

Benefits offered by this job

Paid time off

Health plans

Retirement contributions

Employee Assistance Program

Pet insurance

Job summary

Serán BioScience in Bend, Oregon, is looking for a Quality Assurance Associate to support regulatory compliance in drug manufacturing. The role involves tasks like auditing, risk management, and quality systems oversight. Candidates should have a Bachelor’s degree and a minimum of 3 years in quality assurance or related experience.

Serán offers benefits including over four weeks of paid time off, retirement contributions, and health plan options to meet diverse needs. Join us to contribute to high-quality pharmaceutical products!

Qualifications

• Minimum of 3 years of quality assurance experience.
• Ability to lift up to 15 pounds and wear PPE.
• Collaborative and cross-functional teamwork experience.

Responsibilities

• Participates in internal and third-party audits.
• Supports client audits and regulatory inspections.
• Assists in the oversight of the company’s quality systems.

Skills

Knowledge of GMP and FDA regulations for drug manufacturing

Excellent verbal and written communication skills

Time management skills

Organizational skills and attention to detail

Analytical and problem-solving skills

Education

Bachelor’s Degree in a scientific discipline

Tools

Veeva

Job description

Serán BioScience is searching for an experienced Quality Assurance Associate to aid in regulatory compliance for the manufacturing of oral solid dosage drug products. As a Quality Assurance Associate, you will be responsible for performing the day‑to‑day tasks of the QA Department supporting a GMP facility manufacturing and testing pharmaceutical products. Tasks include auditing and audit support, supplier quality management, and continuous improvement. Additional responsibilities include Quality Management System, risk analyses, change management and investigations/CAPA. Preference will be given to candidates with Quality Assurance experience in the pharmaceutical industry, while those with quality oversight experience are encouraged to apply.

Responsibilities

• Participates in internal and third‑party audits.
• Supports client audits and regulatory inspections.
• Supports company’s supplier quality program.
• Assists in the oversight and implementation of continuous improvement of the company’s quality systems.
• Supports the risk management program and conducts risk assessments.
• Document authorship, review, and approval of SOPs, reports, and quality records.
• Other related duties as assigned.

Qualifications and Requirements

• Knowledge of GMP and FDA regulations for drug manufacturing (21CFR 210-211).
• Excellent verbal and written communication skills.
• Excellent time management skills and a proven ability to meet deadlines.
• Excellent organizational skills and attention to detail.
• Demonstrated ability to collaborate and work in cross‑functional teams.
• Scientific curiosity and willingness to learn.
• Strong analytical and problem‑solving skills.
• Ability to prioritize tasks and delegate when appropriate.
• Minimum of a Bachelor’s Degree, preferably in a scientific discipline.
• 3+ years of previous manufacturing, quality control, or quality assurance experience.
• Working knowledge of Veeva preferred.
• 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.
• Ability to wear required personal protective equipment (PPE) including safety glasses, hearing protection, hard hat, and safety shoes.
• Adheres to consistent and predictable in‑person attendance.

Application Requirements

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.

Additional Information

Visit https://www.seranbio.com/careers to learn more about company culture and the community of Bend, Oregon.

Location

The Corporate Headquarters of Serán BioScience are located at 63047 Layton Ave, Bend, OR 97701.

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.