What are the responsibilities and job description for the QA Specialist position at Actalent?
Our rapidly growing CMO client is looking to bring on a QA specislit to join their organzation on a full time basis. If you are interested, please apply and send your resume to marcmill@actalentservices.com
Top Skills' Details
CAPA
Audits
Deviations
QA
SOP
SOP Writing
Risk Assessment
Quality control
Description:
Develop, review, and approve Quality System SOPs
Review technical data in support of GLP/GMP operations
Execute and track Quality System Events (e.g., deviations, CAPAs, risk assessments, and change controls)
Participate in root cause analysis investigations to identify, mitigate, and prevent nonconformances
Review and approve master batch records for GMP Tissue Foundry processes
Own the document control and issuance processes
Perform line clearances of manufacturing spaces
Ensure site readiness for audits and regulatory inspections
Additional Skills & Qualifications:
Bachelor of Science Degree in life sciences or engineering discipline
Minimum of 2 years of direct work experience in of experience in GMP biotech/pharmaceutical Quality
Knowledge of FDA regulations, especially 21 CFR Part 210 and 211
Comfortable executing multiple quality system efforts in a fast-paced, dynamic, and highly collaborative team environment
Proficient with Microsoft software products, especially formatting within MS Word
About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Salary : $70,000 - $90,000
