Quality Associate-Quality Operations
Core
Supports daily QA and production activities in pharmaceutical distribution, ensuring compliance and accuracy in packaging and serialization.
Role type
Quality Associate (Production Support)
Builds
Compliant pharmaceutical packaging batches and serialized products for distribution
Domain
Pharmaceutical distribution / Quality Operations
Required skills
cGMP compliance knowledge, batch record auditing, serialization management, deviation handling, root cause analysis, SOP creation/review, specific gravity testing, TOC analysis, cleaning validation swabbing, ERP system usage, mathematical skills, problem-solving
Preferred skills
None stated
Technologies
ERP Systems, Microsoft Office (Outlook, Word, Excel)
Responsibilities
Audit production batch records for accuracy and compliance; perform serialization activities (print, release, suspend, clone work orders); verify and correct product/packaging discrepancies; ensure deviations and documentation are provided in batch records; perform in-process quality checks; conduct Specific Gravity testing and TOC analysis; perform cleaning validation swabbing; create, review, and update Work Instructions (WIs) and SOPs; escalate non-conformance issues and lead root cause analysis; participate in internal audits; engage in continuous improvement activities.
Seniority
Entry-level, hands-on IC
