Quality Assurance Senior Specialist

Serán BioScience; Bend (OR); On-site; USD 90,000 - 125,000; Full time

Benefits offered by this job

Paid time off

Retirement plan

Health plans

Life insurance

Job summary

Serán BioScience in Bend, OR seeks a Quality Assurance Senior Specialist to lead day-to-day QA operations for a GMP facility involved in manufacturing, storing, and testing pharmaceutical products.

You will oversee audits, supplier quality, and the quality risk management program, driving CAPA and continuous improvement across QA systems and documentation.

Qualifications

• Bachelor's degree in a scientific discipline or equivalent required.
• 8+ years of quality assurance experience including auditing and supplier quality.
• Experience with GMP/Regulatory expectations for clinical and commercial materials preferred.

Responsibilities

• Perform internal and third-party audits and support regulatory inspections.
• Oversee supplier quality program including supplier qualification and audits (travel may be required).
• Develop and manage audit responses, CAPA plans, and effectiveness checks.
• Assist in quality systems improvement and risk management program administration.
• Document authorship, review, and approval of SOPs, reports, and quality records.

Skills

GMP knowledge

FDA/EMA knowledge

Communication

Time management

Organization

Cross-functional collaboration

Analytical skills

Prioritization & delegation

Scientific curiosity

Education

Bachelor's degree in a scientific discipline

Tools

Veeva

Job description

Serán is seeking a Quality Assurance Senior Specialist who will be responsible for performing the day-to-day tasks of the QA Department supporting a GMP facility manufacturing, storing, and testing pharmaceutical products. Primary responsibilities include overseeing Supplier Quality, Auditing (supporting regulatory and client audits, conducting internal and vendor audits), and managing the Quality Risk Management program. Tasks include audit management, audit response, facilitating audit related continuous improvements, negotiating/processing Quality Agreements and continuous improvement. Additional responsibilities include Quality Management System, risk analyses, change management and investigations/CAPA.

Duties & Responsibilities

• Performs internal and third-party audits.
• Supports regulatory inspections and client audits. Manages and improves audit program.

• Provides direction on audit operational activities and the development of audit responses, CAPA plans, and Effectiveness Checks.

• Oversees company’s supplier quality program including supplier qualification and audit (some travel required)
• Assists in the oversight, facilitation, and implementation of continuous improvement of the company’s quality systems
• Administers the quality risk management program and conducts risk assessments
• Document authorship, review, and approval of SOPs, reports, and quality records.

Required Skills & Abilities

• Knowledge of GMP and FDA regulations for drug manufacturing (21CFR 210-211).
• Knowledge of GMP, FDA, and EMA expectations for clinical trial and commercial materials, manufacturing, and testing
• 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 & Experience

• Minimum of a Bachelor's Degree, preferably in a scientific discipline
• 8+ years previous quality assurance experience including Auditing and Supplier Quality experience
• Working knowledge of Veeva preferred

Physical Requirements

• Prolonged periods of sitting at a desk and working on a computer
• Must be able to lift up to 15 pounds

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