Production Supervisor, Cleanroom & GMP Operations

Vybond

Franklin, Northern (KY, KY)

Hybrid

USD 90,000 - 130,000

Full time

14 days+

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Job summary

Vybond, based in Franklin, KY, seeks an experienced production leader to supervise daily operations in a regulated manufacturing environment. You will ensure safety, quality, and productivity while guiding teams through training, performance management, and compliance activities.

Responsibilities include approving production records, leading investigations, and driving CAPA actions. Candidates should have strong leadership, ISO/FDA knowledge, and ERP/MRP experience to maintain schedule integrity

Qualifications

4 year degree or equivalent combination of education and experience preferred.
General manufacturing experience required.
Demonstrated ability to lead others.
Good interpersonal skills when dealing with tough employee issues.
Proficient in MS Suite, basic computer skills, typing and email etiquette skills required.
Experience working in a medical device, pharmaceutical, aerospace, or other regulated manufacturing environment preferred.
Knowledge of ISO 13485, FDA 21 CFR Part 820, GMP, or similar quality systems preferred.
Experience with ERP/MRP systems, MES, or electronic documentation systems.
Experience leading root cause analysis and corrective action efforts (5-Why, Fishbone, CAPA).
Ability to work in a controlled environment requiring attention to detail, procedural discipline, and consistent execution.

Responsibilities

Ensure compliance with cleanroom procedures, cGMP, ISO requirements, regulatory standards, company policies, and approved work instructions.
Supervise daily manufacturing operations to achieve safety, quality, productivity, delivery, and compliance objectives.
Promote a safe work environment and ensure timely escalation and resolution of safety, quality, equipment, and production issues.
Lead, coach, and develop employees through training, performance management, recognition, accountability, and corrective action when necessary.
Verify employee competency through training completion, skills assessments, qualifications, and certification requirements.
Review and approve production documentation and records to ensure completeness, accuracy, and regulatory compliance.
Partner with Quality Assurance and cross-functional teams to investigate quality issues, nonconformances, deviations, and customer complaints.
Lead containment activities, root cause investigations, corrective actions, and continuous improvement initiatives to improve performance and reduce waste.
Ensure proper handling of raw materials, medical components, and finished products to prevent damage, contamination, or product mix-ups.
Drive adherence to production schedules while maintaining product quality, documentation accuracy, and regulatory compliance.
Monitor, analyze, and communicate departmental performance metrics, including safety, quality, productivity, scrap, labor efficiency, cost, downtime, and on-time delivery.
Lead daily shift meetings to communicate priorities, performance expectations, safety topics, quality requirements, and production goals.
Collaborate with Quality, Engineering, Maintenance, Planning, and other support functions to achieve operational objectives.
Review and approve employee attendance, timekeeping, and time-off requests.