Description
The Quality Control (QC) Specialist II provides Quality Control review and approval of internal and external testing activities, data and documentation to ensure compliance with company procedures. The Quality Control Specialist II also assists with tasks necessary to achieve QC departmental and company goals.
Reporting Relationship
- The Quality Control Specialist II is a Temporary role, roughly 6 months and will report directly to the Senior Director of Quality Control or designee.
About Ascend:
Ascend is pioneering the future of healthcare through relentless innovation, our forward-thinking company is on a mission to manufacture safe, efficacious, and scalable gene therapies. Our vision is to set a new standard for gene therapy manufacturing through continuous scientific and process innovation. Our teams, rooted in biopharma, possess regulatory knowledge and prioritize the quality and potency of manufacturing high-class products.Join us to pursue your passion and make a difference in the industry where there are no limits to what we can achieve.
Requirements
- Reviews data with a focus on internal testing, external contract test laboratory (CTL) testing certificates, Certificate of Analysis and/or Certificate of Test (COT and COA).
- Authors COT and COA within the electronic document management system (ZenQMS system).
- Revise Standard Operating Procedures and forms for QC as required.
- Review documentation, quality control test results and support resolution of Quality Issues (OOS’s, Deviations), as needed.
- Assist with the analysis of trends and metrics to ensure continuous quality improvements within QC.
- Provide data and make updates to QC data for Quality Management Review meetings.
- Other duties as assigned.
- This job description is subject to change at any time.
Educational Qualifications
- Level II - B.S. degree in a scientific discipline and at least five (3) years’ experience (5 preferred) in a cGMP environment, preferably in a biotechnology company
Additional Qualifications
- Understanding of cGMP (drugs and biologics) regulations, guidance documents, systems, processes and procedures (US FDA and EU EudraLex requirements).
- Great attention to detail and ability to review scientific data.
- Strong interpersonal skills to resolve documentation corrections.
- Excellent verbal and written communication skills and ability to communicate effectively with site personnel, peers and management.
- Solid time management skills and ability to handle multiple tasks and deliver high quality results within set timelines
