Quality Assurance (Levels I,II,III)
The Quality Assurance Specialist is to review batch-related documentation and ensure resolution of issues to ensure timely release of final product. The QA is also to work with Manufacturing, Clinical Development and Quality Control, as area Quality Assurance (QA) representative.
- Work as part of a small team to ensure manufacturing is performed using GCP and GMP standards.
- Maintain and audit log books, per established procedures ensuring accuracy and timely completion.
- Flexible and adaptable to schedule procedural changes to ensure timely preparation of products with highest quality.
- Possible contact with 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 a highly preferred.
- Experience in identifying, writing, evaluating and closing investigations. Experience with investigations, deviations, 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.
- Shift and/or weekend work may be required
Benefits & Perks
- Competitive compensation
- Medical, Dental and Vision Insurance
- Business casual work attire
- Fully stocked kitchen and much more!