Senior QA Specialist - Aseptic GMP & Batch Release

Kindeva Drug Delivery; Missouri; On-site; USD 70,000 - 95,000; Full time

Job summary

Kindeva Drug Delivery is seeking a QA Specialist II to provide advanced quality oversight, lead investigations, and ensure timely product release. You will collaborate with cross‑functional teams to implement improvements and maintain regulatory compliance in a fast-paced manufacturing environment.

The role requires experience with batch record review, GMP practices, and aseptic processing, with a focus on continuous improvement and data-driven decision making.

Qualifications

• Bachelor's degree in a science discipline or 3+ years in pharma.
• Experience in Batch Record Review/Disposition.
• Knowledge of cGMPs and regulatory standards.
• Strong problem solving and communication skills.

Responsibilities

• Evaluate and approve batch documentation and determine product disposition per standards.
• Provide quality oversight for manufacturing and testing activities, including line clearance and investigations.
• Identify and resolve non-conformances; recommend corrective actions.
• Review batch acceptance decisions and ensure regulatory alignment.
• Collaborate across departments, apply judgment under tight timelines while upholding quality.

Skills

Batch record review

GMP compliance

Investigations

Change control

Deviation investigation

Quality assurance

Aseptic processing

Data analysis

Documentation

Communication skills

Education

Bachelor's degree in Chemistry, Biology, Microbiology, Pharmacy, Engineering, or related field

3+ years experience in Pharmaceutical industry

Tools

LIMS

ERP software

Job description

Kindeva Drug Delivery is seeking a QA Specialist II to provide advanced quality oversight, lead investigations, and ensure timely product release. You will collaborate with cross‑functional teams to implement improvements and maintain regulatory compliance in a fast-paced manufacturing environment.

The role requires experience with batch record review, GMP practices, and aseptic processing, with a focus on continuous improvement and data-driven decision making.