Senior QA Specialist – Batch & Compliance Expert

Kindeva; Maryland Heights (MO); On-site; USD 65,000 - 85,000; Full time

Job summary

Kindeva is seeking a QA Specialist II to provide advanced quality oversight in product disposition, investigations, and change control. This role applies specialized knowledge to resolve quality issues, lead investigations, and ensure timely product release while partnering with cross-functional teams.

The position requires experience with batch record review, cGMPs, aseptic processing, and internal GMP audits; willingness to work weekends; strong communication; and ability to operate under

Qualifications

• Bachelor's degree in science or 3+ years in pharma or related industry.
• Experience in Batch Record Review/Audit/Disposition.
• Knowledge of cGMPs (USFDA, Health Canada, PIC/S and/or Eudralex).
• Decision making for Incident Investigation and CAPA focus.
• Strong written and oral communication skills.
• Certified Quality Auditor (CQA) certification preferred.

Responsibilities

• Evaluate and approve batch documentation and determine product disposition.
• Provide QA oversight for manufacturing and testing activities, including investigations and change control.
• Independently identify and resolve non-conformances; recommend corrective actions.
• Review SOPs, Forms, Logbooks, and Master Batch Records for accuracy.
• Participate in internal GMP audits and support customer/regulatory audits.
• Perform ERP transactions to ensure documentation integrity.
• Willing to work weekends and holidays as needed.
• Other tasks assigned by management requiring quality expertise.

Skills

Batch record review

cGMPs knowledge

Data analysis

Communication skills

Teamwork

Decision making

Aseptic processing

SOP mastery

Quality audits

Problem solving

Education

Bachelor's in science or 3+ years pharma experience

Tools

ERP transactions

Job description

Kindeva is seeking a QA Specialist II to provide advanced quality oversight in product disposition, investigations, and change control. This role applies specialized knowledge to resolve quality issues, lead investigations, and ensure timely product release while partnering with cross-functional teams.

The position requires experience with batch record review, cGMPs, aseptic processing, and internal GMP audits; willingness to work weekends; strong communication; and ability to operate under