Quality Assurance Associate II/III -Quality Management System

United States·BendFull-time Exemptmid

OtherQuality Assurance Associate

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Overview

Serán BioScience is searching for an experienced Quality Assurance Associate to support quality systems programs. As a Quality Assurance Associate,

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OtherQuality Assurance Associate

Serán BioScience is searching for an experienced Quality Assurance Associate to support quality systems programs. As a Quality Assurance Associate, you will be responsible for performing the day-to-day tasks of the QA Department in a GMP facility manufacturing pharmaceutical products. Tasks include supporting quality system programs such as document management, training, and quality event programs. Additional responsibilities include assisting in the maintenance of the electronic Quality Management System, conducting risk analyses and investigations, and participating in audits and inspections. Preference will be given to candidates within the pharmaceutical industry, while those with Quality oversight experience encouraged to apply.

Supports the implementation and continuous improvement of the company’s Quality systems

Assists in monitoring of Serán quality systems through trending and metrics analysis

Supports the management of Serán’s quality systems through program oversight and eQMS administrative functions.

Document authorship, review, and approval of SOPs, reports, and quality records

Oversight of investigation and CAPA program management

Supports internal audits, client audits and regulatory inspections, as needed

Other related duties as assigned

Knowledge of GMP and FDA regulations for clinical trial materials preferred

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

Demonstrated experience in characterization and analytical techniques relevant to the pharmaceutical industry

Demonstrated experience with advanced laboratory and data analysis skills preferred

Strong analytical and problem-solving skills

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 and/or SAP 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

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