Senior Quality Assurance Associate

Bend, Oregon /
Quality – Quality Assurance /
Full-time Exempt
/ On-site
Serán BioScience seeks an experienced associate to join our Quality Assurance division. In this role you will support the implementation and continuous improvement of the quality system within the QA department by ensuring GMP regulations and internal SOPs are followed throughout the manufacturing process. You will be responsible for reviewing and approving production records, analytical data, and internal documentation as required. Additional responsibilities will include conducting risk analyses and investigations, authoring standard operating procedures, performing supplier qualification activities, and leading internal and external audits and inspections. Industry experience with GMP and FDA regulatory knowledge is required for this role. Preference will be given to those with greater years of experience, while various amounts of QA or QC work within a GMP environment are encouraged to apply.

Supervisory Responsibilities

    • Interviews, trains, and mentor’snew staff 
    • May have supervisory roles for projects or subgroups of QA department 
    • Initiates preventive and corrective actions 
    • Performs other related duties as assigned 

Duties and Responsibilities

    • Leads the implementation and continuous improvement of the company’s quality systems and onboarding of new projects/programs within the QA department 
    • Document authorship, review, and approval of SOPs, batch production and quality control (QC) records, certificates of analysis, method validations, and equipment qualifications 
    • Oversight ofinvestigations and supplier qualification 
    • Corrective and preventive actions (CAPA) program management 
    • Management of internal audits, client audits and regulatory inspections, as needed 
    • Responsible for controlled document issuance and archival 
    • Performs quality reviews independently 
    • Communicates quality-related information to internal team and external clients 
    • All other duties as assigned  

Required Skills and Responsibilities

    • Excellent verbal and written communication skills
    • Excellent interpersonal and customer service skills 
    • Excellent organizational skills and attention to detail 
    • Excellent time management skills with a proven ability to meet deadlines
    • Strong analytical and problem-solving skills
    • Ability to prioritize tasks and to delegate them when appropriate 
    • Ability to function well in a high-paced and at times stressful environment
    • Proficient with Microsoft Office Suite or related software
    • Advanced knowledge of GMP and FDA regulations for clinical trial and commercial materials 
    • Advanced understanding of change control procedures, CAPA program, investigation and root cause analysis, and good documentation practices 

Education and Experience

    • Minimum of a bachelor’s degree, preferably in a scientific discipline 
    • 4 years previous GMP experience in QC or QA roles, 5-10 years preferred  
    • Level/title and compensation will be commensurate with education and experience

Physical Requirements

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