
Job Information
Sun Pharmaceuticals, Inc QA Specialist II in Billerica, Massachusetts
QA Specialist II
Location MA, Billerica
Job Category Quality Assurance
Employment Duration Full time
Executes all activities involving quality assurance and compliance utilizing Current Good Manufacturing Practices (cGMP) requirements for pharmaceuticals and medical devices. Responsible for providing Quality Assurance support to Manufacturing Operations relative to the production of commercial and/or clinical products.
Responsibilities
Review manufacturing batch records and quality control testing data for lot release and stability, ensuring conformance to approved procedures and cGMP
Review SOPs, logbooks, and other documentation related to daily QA activities including raw material release.
Perform QA coverage of GMP operations including manufacturing, labeling/packaging, QC testing, warehouse
Perform walkthroughs of GMP areas documenting observations and areas of concern.
Complete monthly QA metrics
Perform line clearances in manufacturing areas including labeling/packaging
Support internal audits of cGMP operating groups as necessary to ensure compliance to cGMP, internal procedures and policies
Write and/or review Standard Operating Procedures
Review and approve document change controls
Review and approve CAPA, PRA and non-conforming product reports
Execute continuous improvement projects as assigned
Other duties as assigned
Qualifications
Minimum 2-4 years related experience preferably in pharmaceutical (manufacturing) environment, Quality
BS in life science preferred or equivalent related experience
Works under limited supervision using independent judgment and exhibits strong attention to detail
Good verbal, written and interpersonal skills
Assurance, Quality Control and/or production, or FDA regulated industry
Working knowledge of cGMPs Standards
Experience in pharmaceutical environment (manufacturing and/or Quality)
Sun Pharmaceuticals, Inc
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