https://nkgenbiotech.com/wp-content/uploads/2021/04/NKGen-Biotech-300x88.png 0 0 Denise Chua https://nkgenbiotech.com/wp-content/uploads/2021/04/NKGen-Biotech-300x88.png Denise Chua2019-11-07 10:34:292019-12-04 00:36:44Quality Assurance II – FT – Santa Ana, CA
Quality Assurance II – FT – Santa Ana, CA
- Review batch-related documentation and ensure resolution of issues to ensure timely release of final product.
- Ensure products are manufactured in compliance with regulatory and GMP guidelines.
- Work with Manufacturing, Clinical Development and Quality Control, as area Quality Assurance (QA) representative.
- Own and/or approve change controls to manage new materials and material changes.
- Develop and assist in maintaining the audit schedule and approved supplier list for assigned suppliers.
- Perform ongoing evaluation of quality systems, that include but are not limited to, the quality audit program, vendor qualification system & the corrective action program.
- Support inspection readiness plans and interact with regulatory agencies during inspections on quality related matters, as needed.
- Perform other duties as assigned.
- Work as part of a small team to ensure manufacturing is performed using GCP and GMP standards.
- Generates COAs for product release.
- Perform procedures and maintain accurate documentation in compliance with FDA’s Good Laboratory Practices, Good Clinical Practice, Good Manufacturing Practices.
- Maintain and audit log books, per established procedures ensuring accuracy and timely completion.
- Work in clean room environment that requires specialized gowning such as double gloves, hair net, masks, safety glasses, sterile jumpsuit and shoe covers.
- Must maintain and apply knowledge regarding patient information, screening and testing, labeling and product acceptability and release criteria.
- Flexible and adaptable to schedule procedural changes to ensure timely preparation of products with highest quality.
- Handle human blood and human blood base product.
- Other duties as assigned.
- Education: Bachelor’s degree in biochemistry or related biological field and minimum of 3-5 years progressive experience in a pharmaceutical, biotechnology, or biologics operation and/or equivalent education/work experience. Master’s degree in a related science for a minimum of 4 + years highly preferred.
- Experience in identifying, writing, evaluating and closing investigations. Experience with investigations, deviations, and CAPA as well as with internal and external audits.
- Working knowledge of and ability to apply Good Manufacturing Practice (GMP) in conformance to US FDA standards.
- Highly detail oriented and excellent interpersonal skills within collaborative work environment.
- If required, ability to work on weekend, off-shift and long hours.
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
- Strict adherence to SOP’s and cGMP regulations, the ability to accurately complete documentation associated with clinical manufacturing.
- Self-motivated and willing to accept responsibilities outside of initial job description.
- Ability to lift over 30lbs.
- Excellent technical skills; Microsoft Word, Excel and Data Analysis.
- Exceptional time management, problem solving and organization skills.
- Outstanding interpersonal skills, verbal and written communication, in collaborative work environment setting.