Quality Specialists II’s & III’s (on-site only)
Excellent API Manufacturer in the beautiful Southeast is seeking QA Specialists II’s & III’s (Contract or FT). The client is a mid-sized biopharmaceutical organization manufacturing custom and generic products, on the fast-track to great success. They have doubled in size over the last 3 years and are expecting to go public in the coming year.
The ideal candidates will have a Bachelor’s Degree in Life Sciences or Engineering with a QA certification and 4 to 8 years of Quality Assurance experience.
- Thorough background and knowledge of relevant Pharma regulations/standards, i.e., GMP’s FDA 21CFR210/211, ICH Q7, FDA 21CFR1271, ISO9001 to enforce compliance
- Expertise with eQMS, to generate, review and approve documents, CAPA’s, reports, product reviews (APR’s) policies, procedures and controls to ensure Quality & Regulatory Compliance
- Expertise with hosting internal and external audits, interacting with regulatory entities, vendors, contract labs and suppliers
- Ability to monitor and control supplier, vendor, contract lab programs, and interact with leadership teams to effectively assess impact/risks, and deviations
This is the perfect time to join this biopharma organization. If qualified and interested, please submit your resume. This is a great growth opportunity, with a competitive salary and benefits.