QA Senior Specialist – QA for QC | Just. – Redmond, WA
Just is seeking a highly motivated and self-directed Quality professional who desires a significant opportunity to improve worldwide access to biotherapeutics. In this position, you will work as a member of a small highly experienced and innovative team to ensure high quality standards for the safe and reliable production of biological products. The Senior QA Specialist works cross-functionally to ensure compliance in operations to cGMP expectations and company SOPs. The Sr. Specialist is responsible for increasingly complex records and tasks, as well as training of junior personnel. The responsibilities of the employee is based on the assigned QA organization as outlined below.
Responsibilities:
- Review the QC testing and method transfer documents to ensure compliance with all regulatory requirements, company policies, values, and goals.
- Review QC owned quality records such as CAPAs, Stability protocols/reports, and other quality documents as required.
- Lead process improvements within the QA for QC.
- Support/drive cross-training across QC Labs.
- Audit/inspection support for QA QC Site department as required.
- Partners with other QA peers to ensure consistency and efficiency within the QA department.
- Alert senior management of significant quality, compliance, supply, and safety risks.
Qualifications
- Bachelor’s degree in biological or engineering science
- Minimum of 5 years relevant experience in a biopharmaceutical/Pharmaceutical cGMP manufacturing or similar environment.
- Ability to collaborate and communicate cross-functionally.
- Proven attention to detail
Preferred Qualifications:
- Quality Control working experience – preferably in documents revision and approval level.
- OOS and investigation experience
- Experience in helping to build and maintain a Quality infrastructure in a fast-paced growing company.
- Comprehensive understanding of biologics regulatory requirements, risk management principles, and science-based decision making.
- Experience in laboratory testing such as: SEC UHPLC, Potency and Residual Protein (ELISA), Osmolality, Solo VPE, Capillary Electrophoresis (SDS/rCE-SDS), Assay (icIEF),
- Experience in release testing, stability testing, equipment qualification, and method qualification
- Experience in tools, concepts, and methodologies of QA
- Strong computer skills including Microsoft Office and eQMS databases, including LIMS, CMMS, MES
- Key competencies in verbal and written communication; attention to detail; data collection, management, and analysis; judgement and decision making; and building teams.
This job description is intended to describe the general content of the job, and to identify the essential functions of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Because job requirements evolve with the changing needs of Just-Evotec Biologics business, this description is subject to change and may be modified at any time, whether formally or informally.
The base pay range for this position at commencement of employment is expected to be $91,560 to $123,350; Base salary offered may vary depending on the individual’s skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits.
Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.
Top Skills
What We Do
Evotec is a biotechnology company that is committed to advancing drug discovery and development. Through flexible business models, we collaborate with pharmaceutical companies, biotechs, foundations, and government agencies on a substantial scale. We believe that by working together, we can make a difference in the lives of patients.
Our Pipeline Co-Creation model represents our adaptable, multi-modality, fully integrated end-to-end approach to drive collaborations and services across all phases of drug discovery and development – from discovery of novel targets to achieving Proof of Concept in the clinic and into commercial manufacturing.
We aspire to contribute data-driven disease understanding and early disease relevance in humans to bring the probability of success up. We select the right modality, which is then propelled forward on our platforms by our passionate people striving for the fastest and most effective ways towards patient impact. This is enabled by convergence of human ingenuity with data and AI.
We also offer specific solutions, products, and CRO/CDMO-like services, always in support of the Biopharma R&D innovator. Our more than 4,000 scientists work closely with numerous partners concurrently, delivering fully integrated research and development portfolios or individual projects with the highest quality standards and efficiency, coupled with great science, passion, engagement, and communication.
