Senior QA Specialist - Quality Systems & Compliance Lead

Kindeva; Brentwood (MO); Sur place; USD 90 000 - 120 000; Plein temps

Résumé du poste

Kindeva is seeking a Senior QA Specialist to provide strategic quality oversight and lead projects that enhance compliance and efficiency in manufacturing and testing. You will manage investigations, change control, and product release while driving continuous improvement initiatives.

You will collaborate across functions, lead QA activities, and ensure alignment with regulatory requirements, applying advanced judgment in a fast-paced environment.

Qualifications

• Bachelor’s degree in a science field or 5+ years in pharma.
• Experience in Batch Record Review/Audit/Disposition.
• Knowledge of cGMPs (USFDA, Health Canada, PIC/S and/or Eudralex).
• Demonstrated decision-making in incident investigations and CAPAs.
• Project management experience.
• Strong written and oral communication.
• Certified Quality Auditor (CQA) Certification preferred.

Responsabilités

• Lead and approve complex document reviews to ensure manufacturing and testing processes comply with approved batch/testing records, SOPs, and cGMP standards.
• Provide strategic QA oversight and guidance for manufacturing and testing activities, including shop floor support and deviation investigations.
• Identify, resolve, and influence corrective actions for non-conformances; drive systemic improvements.
• Review and decide batch acceptability and product disposition for high-impact decisions.
• Collaborate cross-functionally to lead quality initiatives under short timelines.
• Collect, analyze, and interpret data to identify trends and improve quality systems.

Connaissances

Batch record review

Audit

Disposition

cGMP knowledge

Project management

Decision making

Communication skills

Data analysis

Team collaboration

Quality improvement

Formation

Bachelor’s degree in Chemistry, Biology, Microbiology, Pharmacy, Engineering, or related science

Description du poste

Kindeva is seeking a Senior QA Specialist to provide strategic quality oversight and lead projects that enhance compliance and efficiency in manufacturing and testing. You will manage investigations, change control, and product release while driving continuous improvement initiatives.

You will collaborate across functions, lead QA activities, and ensure alignment with regulatory requirements, applying advanced judgment in a fast-paced environment.