GMP QA Associate: Compliance, Audits & Improvement

Medium; Bend (OR); On-site; USD 65,000 - 85,000; Full time

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.

Duties and 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.

Required Skills and Abilities

• Knowledge of GMP and FDA regulations for drug manufacturing (21CFR 210-211).
• Excellent verbal and written communication skills.
• Excellent time management skills with 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 to delegate them when appropriate.

Education and Experience

• Minimum of a Bachelor's Degree, preferably in a scientific discipline.
• 3+ years previous manufacturing, quality control, or quality assurance experience.
• Working knowledge of Veeva preferred.

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.
• 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.

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.