NCBiotech
Supervisor - Operations Visual Inspection
NCBiotech, Durham, North Carolina, United States, 27703
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life‑changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
Organization Overview At Lilly, we serve an extraordinary purpose. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world’s greatest health challenges.
Lilly is expanding its new state‑of‑the‑art Parenteral, Device Assembly, and Packaging Facility in Raleigh‑Durham North Carolina. This is an exciting opportunity to help drive excellence in a state‑of‑the‑art facility and Quality System.
Responsibilities This position will start on an 8‑hour M‑F shift for orientation. Incumbent will then transition to a 12‑hour, 2‑2‑3 rotating day schedule within 2‑3 weeks. During the project phase, the Operations Supervisor – Visual Inspection will support commissioning/qualification activities required to bring automated and semiautomated inspection lines into service, as well as supporting site operational readiness activities. This role is expected to be an on‑the‑floor leader and will be a subject matter expert for the visual inspection process. This role will have the opportunity to be directly involved with hiring team members.
Concurrent with the project phase, the Operations Supervisor – Visual Inspection is responsible for shift leadership for multiple drug product inspection lines within the area, as well as developing technical expertise of manufacturing employees. This individual must ensure that the manufacturing lines are adequately staffed with trained/qualified employees. Strict adherence to safety and quality rules and procedures is required. This is direct line supervision for line leaders and operators on a 12‑hour shift rotation schedule.
Key Objectives
Support Site Leadership to build a diverse, inclusive, and capable site organization by delivering area operational procedures, quality processes and controls for Parenteral areas
Responsible for hiring/managing 10+ direct reports working across multiple manufacturing lines
Responsible for maintaining a safe work environment, working safely, and accountable for supporting all HSE goals
Ensures qualified/trained staffing for operators working on the manufacturing lines
Communicate with the area Manager on quality, equipment, and operational issues and areas for improvement
Responsible for the coaching, development, and performance evaluation of operators/technicians
Originate/Investigate deviations or operational quality issues
Collaborate with support functions to achieve a consensus for unexpected events during manufacturing
Act as both administrator and technical leader for operations, setting a good example through demonstrated knowledge of procedures, compliance with quality systems and use of proper technique
Responsible for shop floor execution as it relates to business plan and current Good Manufacturing Practice (cGMP) conformance
Basic Requirements
High School Diploma or equivalent
2+ years previous experience in operations or directly supporting a pharmaceutical manufacturing operation
Demonstrated leadership experience with an emphasis on respect for people
Skills in providing/receiving feedback and creating employee development plans
Basic computer skills (desktop software) are required
Strong understanding of FDA guidelines and cGMP requirements
Excellent interpersonal, written and oral communication skills
Strong organizational skills and ability to handle and prioritize multiple requests
Strong technical aptitude and ability to train and mentor others
Ability to work overtime as required
Ability to travel
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H‑1B or TN status) for this employment position
Additional Skills/Preferences
Bachelor’s Degree in science, engineering, or technical field
Previous experience with automated, semiautomated, and manual visual inspection processes/equipment
Previous experience in facility/area start‑up environments
Previous experience with Manufacturing Execution Systems and electronic batch release
Experience with root cause analysis/technical writing
#J-18808-Ljbffr
Organization Overview At Lilly, we serve an extraordinary purpose. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world’s greatest health challenges.
Lilly is expanding its new state‑of‑the‑art Parenteral, Device Assembly, and Packaging Facility in Raleigh‑Durham North Carolina. This is an exciting opportunity to help drive excellence in a state‑of‑the‑art facility and Quality System.
Responsibilities This position will start on an 8‑hour M‑F shift for orientation. Incumbent will then transition to a 12‑hour, 2‑2‑3 rotating day schedule within 2‑3 weeks. During the project phase, the Operations Supervisor – Visual Inspection will support commissioning/qualification activities required to bring automated and semiautomated inspection lines into service, as well as supporting site operational readiness activities. This role is expected to be an on‑the‑floor leader and will be a subject matter expert for the visual inspection process. This role will have the opportunity to be directly involved with hiring team members.
Concurrent with the project phase, the Operations Supervisor – Visual Inspection is responsible for shift leadership for multiple drug product inspection lines within the area, as well as developing technical expertise of manufacturing employees. This individual must ensure that the manufacturing lines are adequately staffed with trained/qualified employees. Strict adherence to safety and quality rules and procedures is required. This is direct line supervision for line leaders and operators on a 12‑hour shift rotation schedule.
Key Objectives
Support Site Leadership to build a diverse, inclusive, and capable site organization by delivering area operational procedures, quality processes and controls for Parenteral areas
Responsible for hiring/managing 10+ direct reports working across multiple manufacturing lines
Responsible for maintaining a safe work environment, working safely, and accountable for supporting all HSE goals
Ensures qualified/trained staffing for operators working on the manufacturing lines
Communicate with the area Manager on quality, equipment, and operational issues and areas for improvement
Responsible for the coaching, development, and performance evaluation of operators/technicians
Originate/Investigate deviations or operational quality issues
Collaborate with support functions to achieve a consensus for unexpected events during manufacturing
Act as both administrator and technical leader for operations, setting a good example through demonstrated knowledge of procedures, compliance with quality systems and use of proper technique
Responsible for shop floor execution as it relates to business plan and current Good Manufacturing Practice (cGMP) conformance
Basic Requirements
High School Diploma or equivalent
2+ years previous experience in operations or directly supporting a pharmaceutical manufacturing operation
Demonstrated leadership experience with an emphasis on respect for people
Skills in providing/receiving feedback and creating employee development plans
Basic computer skills (desktop software) are required
Strong understanding of FDA guidelines and cGMP requirements
Excellent interpersonal, written and oral communication skills
Strong organizational skills and ability to handle and prioritize multiple requests
Strong technical aptitude and ability to train and mentor others
Ability to work overtime as required
Ability to travel
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H‑1B or TN status) for this employment position
Additional Skills/Preferences
Bachelor’s Degree in science, engineering, or technical field
Previous experience with automated, semiautomated, and manual visual inspection processes/equipment
Previous experience in facility/area start‑up environments
Previous experience with Manufacturing Execution Systems and electronic batch release
Experience with root cause analysis/technical writing
#J-18808-Ljbffr