Quality Assurance Specialist- Remote

Description:

The QA Specialist will perform activities related to preparation activities for regulatory pre-approval inspections. The specialist will support a QA GMP Lead in all activities including audit and reconciliation of documentation for manufacturing records from external manufacturing CMOs, method validations, change control, CAPA, deviations and investigations, and of compliance logs. They will interact with internal cross functional groups including Technical Operations, Regulatory Affairs, and Clinical Operations, as well as Contract Manufacturing Organizations and Analytical Laboratories.

Qualifications:

Must have Pharmaceutical QA Experience

•BA/BS in Biology or related Science preferred, or equivalent experience

•2-3 years of experience in Pharmaceutical ,

•2+ years of experience within Quality Systems

•Experience with batch records and Quality Events (Change control, deviations, investigations, CAPA) required

•Strong organizational, interpersonal and communication skills, and excellent written communication skills

•Able to communicate efficiently with Contract Manufacturing Organizations and with internal cross-functional teams

Skills:

batch record, gmp, Quality assurance, sop, document management, compliance

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.