Role Summary
Operations Supervisor β Visual Inspection (Night Shift) oversees visual inspection lines, leads on-floor operations, supports commissioning and site readiness, and ensures staffing, safety, and cGMP compliance on a 12-hour night rotation.
Responsibilities
- Lead shift operations for multiple drug product inspection lines, developing technical expertise among manufacturing employees and ensuring adequately staffed, trained personnel.
- Support commissioning/qualification activities to bring automated and semiautomated inspection lines into service and assist with site operational readiness.
- Maintain adherence to safety and quality rules and procedures; act as administrator and technical leader for operations with demonstrated knowledge of procedures and quality systems.
- Coach, develop, and evaluate operators/technicians; originate/investigate deviations or operational quality issues; collaborate with support functions to resolve unexpected manufacturing events.
- Communicate quality, equipment, and operational issues to the area Manager and drive continuous improvement for manufacturing lines.
- Oversee shop floor execution in alignment with the business plan and current Good Manufacturing Practice (cGMP) conformance.
Qualifications
- Required: High School Diploma or equivalent
- 2+ years of experience in operations or directly supporting a pharmaceutical manufacturing operation
- Demonstrated leadership with respect for people; strong communication and interpersonal skills
- Ability to provide/receive feedback and create development plans; strong organizational skills
- Basic computer skills (desktop software); strong understanding of FDA guidelines and cGMP requirements
- Ability to work overtime as required; ability to travel; legally eligible to work in the United States
Education
- Preferred: Bachelorβs Degree in science, engineering, or a technical field
Skills
- Strong technical aptitude and ability to train and mentor others
- Experience with automated, semiautomated, and manual visual inspection processes/equipment
- Experience with Manufacturing Execution Systems and electronic batch release
- Root cause analysis/technical writing; lean manufacturing principles
Additional Requirements
- Position may include short duration assignments in Indianapolis or internationally to establish process knowledge and provide production support
- Ability to wear safety equipment (safety glasses, safety shoes, gloves, etc.)