Will supervise the daily aseptic filling operations / packaging operation at RMD Branchburg. Supervises filling / packaging department with staff of 5-40 employees which conduct the filling and labeling and packaging of diagnostic reagents. Manages the schedule and work assignments for the filling / packaging and labeling areas. Manages the scheduling of automated Filling/ Packaging and labeling equipment so that it meets production demands.
- Resolves scheduling conflicts and production issues in order to meet production and replenishment demands. Leads project-based activities (e.g., new product transfers product validation activities) to support departmental and company goals. Maintains control of work group expenses within limits of DOA.
- Depending upon primary focus of position, supervises work groups which conduct aseptic filling operations, packaging, planning and logistics routine activities. Responsible for the accuracy, quality and timeliness of Filling / Packaging operations and product supply. Keeps manager informed of product and project status, particularly of significant observations and results in critical areas. Ensures that Filling / Packaging group performs work according to established internal safety guidelines and procedures, and as specified by appropriate external regulatory agencies (e.g., OSHA, FDA, ISO).
- Serves as a technical resource for the specific area of supervision assigned. Individual is a mentor to the members of the work group and resolves issues encountered in the logistics and planning processes to improve performance. Provides definition and plans for timely achievement of overall product or project goals and to the expeditious transfer of technologies.
- Leads investigations, write the investigation reports, and advance through the quality system. Makes recommendations, provides or implements process improvements and document improvements. Prepares complex reports, presentations, protocols and other documents.
- Coordinates with Environmental Monitoring Group to address excursions. Ensures all area personnel are trained in job specific SOPs and that all operations are performed in a manners compliant with Master Records and associated SOPs. Writes and/or revises documents (e.g., SOPs, Variances, Rework Orders, Change Requests) to comply with cGMP/ QSR practices.
- Defines and monitors project timelines, ensuring timely achievement of overall project goals and establishing priorities.
- Responsible for providing appropriate training and development opportunities for staff.
- Participates in routine training activities to maintain/enhance own technical skill level and supervisory abilities.
- Job requirement will include ability to perform in the aseptic environment. Wear personal protective equipment, such as eye, foot, lab coat, mask, gowning coveralls.
To perform this job successfully, an individual must be able to perform each responsibility satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the responsibilities.
Education Level Required: Associate's Degree
Preferred: Bachelor's Degree or Master's Degree
Required: 4 years of relevant experience in production, manufacturing or related field
Required: Supervisory/management or leading/directing people
Are equivalencies acceptable?
Yes. Equivalent combination of education and work-related experience.
Knowledge, Skills and Abilities
- In-depth understanding of aseptic filling, environmental monitoring, GMP, ISO, QSR requirements.
- Strong problem-solving skills
- Ability to communicate effectively in small group settings
- Ability to summarize complex information and present same to senior staff
Based on business needs