Quality Assurance Associate, Alternative Shift

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 (clinical and eventually commercial). Tasks include production record review, analytical data review, internal QA 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/inspections. 

There is no better way to enjoy everything that Central Oregon has to offer than having a work schedule that allows you recreation access mid-week. Serán BioScience is expanding its Quality Assurance team to allow for additional manufacturing of pharmaceutical products. Alternative shift consists of a Friday through Monday schedule working four 10-hour shift. Salary shift differential will be applied after site-specific training is complete and shift is adopted. Submit your resume to learn more!

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 is required, commercial
    • 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
    • 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 

Physical Requirements

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