Quality Assurance Specialist II - 2nd Shift
Core
Ensures quality and compliance in manufacturing operations through floor oversight, batch disposition, and regulatory documentation review.
Role type
Quality Assurance Specialist (Manufacturing)
Builds
Pharmaceutical/biologics manufacturing processes
Domain
Life Sciences / Biopharmaceutical Manufacturing
Deliverable
client delivery
Required skills
cGMP compliance, batch record review, deviation investigation, CAPA management, change control, GMP documentation, cleanroom gowning (Level 3), cross-functional collaboration
Preferred skills
Life Sciences or Engineering degree, experience with ISO standards, familiarity with quality systems, proficiency with documentation systems
Technologies
Documentation systems, standard office software
Responsibilities
Review and approve GMP documentation including batch records and QC testing records; Provide QA oversight on the manufacturing floor including walkthroughs and line clearances; Perform QA walkthroughs to resolve quality issues; Ensure compliance with cGMP, ISO standards, and internal quality systems; Support deviations, CAPAs, change controls, and investigations; Maintain and track quality records for audit readiness; Support on-the-floor activities including Level 3 gowning for critical operations
Seniority
Mid-level IC
