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The Role
The Quality Assurance Associate supports quality systems in a GMP facility, managing programs, audits, and documentation. Responsibilities include training oversight, risk analyses, internal audits, and supporting quality improvement initiatives.
Summary Generated by Built In
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.
Duties and Responsibilities
- 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
Required Skills and Abilities
- 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
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 and/or SAP 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
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
Skills Required
- Minimum of a Bachelor's Degree, preferably in a scientific discipline
- 3+ years previous manufacturing, quality control, or quality assurance experience
- Knowledge of GMP and FDA regulations for clinical trial materials
- Working knowledge of Veeva and/or SAP
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The Company
What We Do
Serán Bioscience is a contract development and manufacturing organization (CDMO) that provides comprehensive pharmaceutical support for small and large molecule drug development. They offer services ranging from discovery to clinical manufacturing, including formulation design, spray drying, and analytical quality control, with a science-first approach aimed at helping clients advance medicines to the clinic efficiently.
