Senior Manufacturing QA & Compliance Specialist

Kindeva-Drug-Delivery-Careers; Lexington (KY); On-site; USD 65,000 - 90,000; Full time

Job summary

Kindeva Drug Delivery is seeking a QA Specialist to support on-shift manufacturing operations, review cGMP documentation, and oversee quality during all stages of production and testing.

You will participate in audits, manage deviations and CAPAs, and collaborate with internal teams and external suppliers to ensure regulatory compliance and product quality. The role requires attention to detail and strong writing skills in a fast-paced GMP environment.

Qualifications

• Bachelor's degree in a scientific discipline; 3+ years of cGMP pharmaceutical/medical device quality experience.
• Knowledge of ALCOA+ data integrity and 21 CFR Part 11 for electronic records.
• Knowledge of HPLC principles and ability to review data for accuracy.
• Knowledge of microbiological testing principles and data review.
• Ability to assess problems, plan and implement changes.
• Quality systems auditing experience preferred.
• Familiarity with electronic QMS platforms (TrackWise, MasterControl).
• Experience with aseptically filled, sterile products preferred.
• Advanced knowledge of cGMP regulations and validation (FDA 21 CFR Part 820, ISO 13485).
• Strong teamwork, communication, and technical writing skills.
• Qualified to work with controlled substances.
• Experience in deviation investigations and CAPA implementation.

Responsibilities

• Supports on-shift manufacturing operations and audits batch records, sampling, AQLs, and line clearances.
• Supports development and maintenance of Quality Systems.
• Leads continuous improvement to assure DEA/FDA compliance.
• Advises senior management on audit findings and recommendations.
• Manages deviation, OOS, CAPA, and Change Control Systems.
• Evaluates proposed process/equipment/documentation changes for regulatory compliance; participates in investigations and root cause analysis.
• Ensures timely CAPA implementation and effectiveness checks.
• Reviews and approves cGMP documentation including procedures, batch records, validation protocols, etc.
• Develops and maintains metrics and trending reports for compliance activities.
• Reviews and approves product complaint investigations.
• Performs project-related activities from participation to project management.
• Collaborates with departments and external suppliers on quality concerns.
• Coordinates Compliance Assessments (GxP, 21 CFR Part 11).
• Supports regulatory inspections and customer audits; assists the Manager with daily activities.
• Performs other duties as assigned.

Skills

ALCOA+ data integrity

cGMP knowledge

HPLC knowledge

Microbiological testing

Regulatory compliance

Quality systems auditing

QMS (TrackWise/MasterControl)

Sterile products understanding

Documentation writing

Team collaboration

Education

Bachelor's degree in science

Job description

Kindeva Drug Delivery is seeking a QA Specialist to support on-shift manufacturing operations, review cGMP documentation, and oversee quality during all stages of production and testing.

You will participate in audits, manage deviations and CAPAs, and collaborate with internal teams and external suppliers to ensure regulatory compliance and product quality. The role requires attention to detail and strong writing skills in a fast-paced GMP environment.