Senior QA Specialist: Elevate Quality & Compliance Pharma

Kindeva; Maryland Heights (MO); On-site; USD 70,000 - 100,000; Full time

Job summary

Kindeva is seeking a QA Specialist II to provide advanced quality oversight over batch disposition, investigations, and change control. This role applies specialized knowledge to resolve quality issues, lead investigations, and ensure timely product release.

QA Specialist II partners with cross-functional teams to implement improvements and maintain compliance with regulatory standards. You will review SOPs/master batch records, support line activities, and mentor QA colleagues while upholding

Qualifications

• Bachelor's degree in a science-related discipline or 3+ years in pharma/related industry.
• Experience in Batch Record Review/Audit/Disposition.
• Knowledge of cGMPs (USFDA, Health Canada, PIC/S and/or Eudralex).
• Decision making in incident investigations and CAPA with quality focus.
• Demonstrated ability to work in cross-functional teams under tight timelines.

Responsibilities

• Evaluate and approve batch documentation and determine product disposition per compliance standards.
• Provide QA oversight for manufacturing/testing activities and change control processes.
• Identify and resolve non-conformances; recommend CAPAs.
• Review batch acceptability and product disposition timely.
• Collaborate across departments and mentor QA colleagues.

Skills

Batch Record Review

GMP Compliance

Investigations

Quality Oversight

SOPs & Documentation

Aseptic Techniques

Data Analysis

Education

Bachelor's degree in Chemistry, Biology, Microbiology, Pharmacy, Engineering

Tools

LIMS

Job description

Kindeva is seeking a QA Specialist II to provide advanced quality oversight over batch disposition, investigations, and change control. This role applies specialized knowledge to resolve quality issues, lead investigations, and ensure timely product release.

QA Specialist II partners with cross-functional teams to implement improvements and maintain compliance with regulatory standards. You will review SOPs/master batch records, support line activities, and mentor QA colleagues while upholding