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.
Job Qualifications & Skills
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.