On-Site Senior QA Specialist: Batch Release & Compliance

Continental Manufacturing; Huxley (IA); Vor Ort; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

Continental Manufacturing in Huxley, IA, is seeking a Sr. Quality Assurance Specialist. This on-site role owns batch record review and product release, ensuring compliance with cGMP and ISO 22716 across pharma, cosmetic, and EPA-regulated lines.

Collaborate with QC, Production, and Regulatory teams to maintain the quality management system. The ideal candidate will lead investigations, manage change controls, and drive CAPA closure with minimal supervision, ensuring on-time product disposition

Qualifikationen

• Bachelor’s degree in Chemistry, Biology, Microbiology or related field.
• 3+ years of cGMP quality experience in QA/QC/Quality Engineering in pharma/cosmetic/regulated manufacturing.
• Proficiency with FDA cGMP (21 CFR Parts 210 & 211) and ISO 22716.
• Experience leading investigations (deviation, OOS) and CAPA closure.
• Experience with change controls and SOP/documentation management.
• Auditing of internal and supplier systems per schedule.
• Strong documentation and reporting skills; attention to detail.
• Proficiency in MS Office; familiarity with QA systems preferred.

Aufgaben

• Review and approve batch records to confirm SOP/compliance before disposition.
• Lead end-to-end batch record review and resolve discrepancies.
• Lead deviation and CAPA investigations and drive corrective actions.
• Manage change controls and assess regulatory impact before changes.
• Develop and maintain SOPs and quality documentation.
• Plan and conduct internal and supplier quality audits; track corrective actions.
• Support FDA, EPA, and customer audits with readiness activities.
• Prepare quality metrics and support management reviews.

Kenntnisse

Batch record review

CAPA investigations

FDA cGMP

Change controls

Quality documentation

Audits

Root cause analysis

Cross-functional collaboration

Ausbildung

Bachelor’s degree in Chemistry/ Biology/ Microbiology

Associates degree in Laboratory Technology

Related technical fields degree

Tools

Microsoft Office

Global Shop

SOP management software

Audit support tools

Jobbeschreibung

Continental Manufacturing in Huxley, IA, is seeking a Sr. Quality Assurance Specialist. This on-site role owns batch record review and product release, ensuring compliance with cGMP and ISO 22716 across pharma, cosmetic, and EPA-regulated lines.

Collaborate with QC, Production, and Regulatory teams to maintain the quality management system. The ideal candidate will lead investigations, manage change controls, and drive CAPA closure with minimal supervision, ensuring on-time product disposition