What are the responsibilities and job description for the Quality Assurance Specialist II position at TalentBurst, an Inc 5000 company?
Title: Quality Assurance Specialist II
Duration: 9 Months
Location: Newark Ca
**Onsite in Newark CA**
Description
The Quality Assurance Specialist II is an intermediate level position with hands-on QA experience. Under supervision, the individual will be working in the Product Quality Assurance team, primarily providing quality oversight and support to internal and external drug substance and drug product production and lot disposition. This role will be interacting with cross-functional groups such as Quality Control, Manufacturing, MSAT, Facilities, Supply Chain, and Regulatory Affairs.
Perform a wide variety of quality assurance activities to ensure compliance procedures, applicable US and international regulatory requirements for biologic drug substances and drug products.
Coordinate and perform area approvals and product inspection
Review documents such as standard operating procedures, master batch records, and packaging and labeling records
Review executed production batch records and associated documentation, including any deviations related to batch disposition, for internal manufacturing and external CMO
Perform retain sampling and maintain reserve sample program
Act as a compliance resource to provide guidance and assistance towards resolution of issues under guidance
Perform review and disposition of incoming raw materials
Continuously improve quality operation processes; author/revise existing procedures and forms
Assist in data verification for regulatory submissions
Assist with inspection preparation/strategy in internal compliance audits, regulatory agency inspections, or third-party audits
Update department databases to ensure accurate reporting of quarterly metrics
Skills
Excellent interpersonal, verbal, and written communication skills
Uses experience, knowledge, and judgement to resolve simple issues
Ability to organize and multi-task in a fast-paced environment
Good working knowledge of cGMP standards applicable to commercial biologics
Specific vision abilities required by this job include passing a visual acuity test
Prior experience with regulatory inspections and Veeva is desired
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