Quality Assurance Associate I/II
Bend, Oregon
Quality – Quality Assurance /
Full-time Exempt /
On-site
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 production record review, analytical data review, internal Quality Assurance document review, and support of the production floor. 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
- Document authorship, review, and approval of SOPs, production, and quality control records including batch records, certificates of analysis, method validations, and equipment qualifications
- 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
- Ability to function well in a high-paced and at times stressful environment
- 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
- Ability to prioritize tasks and to delegate them when appropriate
Education and Experience
- Minimum of a Bachelor's Degree, preferably in a scientific discipline
- 2+ years previous manufacturing, quality control, or quality assurance experience
- Working knowledge of Veeva and/or SAP 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.
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. Serán fully funds employees and their household with dental, vision and one medical plan option. 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.
