Quality Control Supervisor
Harba5 months ago
Indianapolis, IN, United States
On-site
Full-time
Junior Level (1-3 years)
Job Description
Job Responsibilities:
- Ensure all operations comply with applicable domestic and international regulatory standards, including FDA, ISO, USP, cGMP, and other industry requirements.
- Collaborate across departments to coordinate laboratory testing schedules and support ongoing production timelines.
- Perform and oversee analytical and quality control testing activities as needed.
- Coordinate testing for raw materials, finished products, stability samples, validation studies, and investigational samples.
- Review and maintain controlled documentation, updating procedures and records when necessary to ensure accuracy and compliance.
- Maintain adherence to company policies, quality systems, safety procedures, and operational standards.
- Assist with investigations related to product deviations, process issues, and customer concerns, including preparation and review of investigation documentation.
- Track and ensure timely completion of corrective and preventive actions (CAPAs).
- Promote safe handling practices in regulated laboratory environments, including maintaining exposure levels within established safety guidelines.
- Lead, mentor, and develop team members while promoting accountability, collaboration, and continuous improvement.
- Communicate departmental goals and align team objectives with broader organizational priorities.
- Provide ongoing coaching, training, and performance feedback to support employee growth and operational success.
- Facilitate daily team meetings to review priorities, communicate updates, and monitor performance metrics.
- Monitor team productivity and communicate progress toward operational goals and key performance indicators.
- Manage staffing needs and overtime requirements while ensuring proper documentation and reporting.
- Support workplace organization, cleanliness, and continuous improvement initiatives within the department.
- Ensure all personnel training and qualification requirements remain current and compliant.
Qualifications:
- Bachelor’s degree in Chemistry, Life Sciences, or a related discipline preferred; equivalent industry experience may be considered.
- Extensive experience in regulated laboratory or quality environments, including prior leadership or supervisory responsibilities.
- Strong background in cGMP laboratory operations and analytical instrumentation.
Required Skills
Quality Control
Continuous Improvement
Documentation Management
FDA Standards
Training and Development
cGMP
Laboratory Safety
Corrective and Preventive Actions (CAPA)
ISO Standards
Regulatory Compliance
Performance Monitoring
Investigations
Mentoring
Analytical Testing
Team Leadership