On-Shift QA & Compliance Specialist (Pharma)

Kindeva; Lexington (KY); On-site; USD 85,000 - 110,000; Full time

Job summary

Kindeva is seeking a Quality Assurance professional to provide on-shift quality oversight across manufacturing, development, and testing. You will review cGMP documentation, participate in raw material and product release, and audit facilities and records for compliance.

You will lead investigations into deviations, OOS results, and CAPA implementations, ensuring timely corrective actions and effective change control, while collaborating with internal teams and suppliers.

Qualifications

• Bachelor's degree in a scientific discipline and 3+ years cGMP quality experience.
• Knowledge of ALCOA+ data integrity and 21 CFR Part 11.
• Experience with HPLC and microbiological testing data.
• Experience conducting internal/external quality audits.

Responsibilities

• Supports on-shift manufacturing operations with batch record audits and line clearances.
• Maintains and improves Quality Systems and tracks metrics.
• Leads continuous improvement to ensure DEA/FDA regulatory compliance.
• Manages deviation, OOS, CAPA, and Change Control investigations.
• Reviews cGMP documentation including batch records and specifications.

Skills

Bachelor's degree

cGMP knowledge

Data integrity ALCOA+

HPLC knowledge

Strong communication

Education

Bachelor's degree in a scientific discipline

Tools

TrackWise

MasterControl

QMS software

Job description

Kindeva is seeking a Quality Assurance professional to provide on-shift quality oversight across manufacturing, development, and testing. You will review cGMP documentation, participate in raw material and product release, and audit facilities and records for compliance.

You will lead investigations into deviations, OOS results, and CAPA implementations, ensuring timely corrective actions and effective change control, while collaborating with internal teams and suppliers.