Quality Control Supervisor - Carmel, IN
2 days ago
Job description
Aegis Worldwide
Quality Control Supervisor
3rd SHIFT/$90-$110k/Full-Time
Carmel, IN
Overview:
Aegis is currently partnered with a bio medical manufacturer.
Responsibilities
- Ensure compliance with all applicable US and international regulatory standards including FDA, EU, ISO, USP, NRC, and cGMP guidelines.
- Coordinate cross-functionally to align QC testing schedules with production plans and ensure all testing and maintenance activities are completed on time.
- Perform and oversee testing of finished product, raw materials, components, stability samples, validation batches, and experimental samples.
- Review, approve, and maintain controlled documents within area of responsibility.
- Lead and support investigations related to deviations, product failures, and customer complaints. Author and review quality and safety reports and drive timely corrective actions.
- Ensure safe handling of radioactive materials and maintain exposure levels As Low As Reasonably Achievable (ALARA).
- Coach, develop, and manage team performance while aligning goals with site objectives and KPIs. Conduct daily huddles and communicate performance metrics.
- Manage department overtime, maintain 5S standards, and ensure training and qualification compliance.
Requirements
- Bachelor's degree in Chemistry, Science, or related field required. Relevant experience may be considered in lieu of degree.
- 10+ years of relevant experience required with prior supervisory experience preferred.
- Strong knowledge of cGMP laboratory operations and major laboratory instrumentation.
- Ability to interpret laboratory data and make sound compliance decisions.
- Proven leadership, communication, coaching, and conflict management skills.
- Strong analytical, problem-solving, and decision-making abilities with capacity to manage multiple priorities.
- Ability to work in a radioactive manufacturing environment and meet physical demands including lifting up to 70 pounds, wearing PPE, standing for extended periods, and working off-shift, weekends, or holidays as needed.
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