Overview
QA Senior Specialist – Site Jobs in Seattle, Washington, USA at Evotec
Position: QA Senior Specialist – Site Based, Redmond, WA
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.
#J-18808-Ljbffr
Title: QA Senior Specialist – Site
Company: Evotec
Location: Seattle, Washington, USA
Category: Quality Assurance – QA/QC (QA Specialist / Manager, Quality Control / Manager, Quality Engineering)
