Note: This a M-W overnight 13hr. shift pattern, typical hours are 8pm to 4:30am. This position is eligible for sign on bonus and shift differential.
Will supervise the exciting and fast paced cobas® Liat filling and pouching operations at RMD Branchburg. This includes leading a highly engaged team of 40+ operators working in a GMP manufacturing environment responsible for the filling, labeling and pouching of cobas® Liat assay tubes. Manages the schedule and work assignments for the team and the automated Filling and Pouching equipment to meet production goals.
• Drive right first time production by ensuring the team has what they need to operate in a manner compliant with Master Records and associated SOPs. Resolves scheduling conflicts and production issues quickly and compliantly to ensure demands are met on time and in full.
• Ensures operators perform work according to established internal safety guidelines and procedures, and as specified by appropriate external regulatory agencies (e.g., OSHA, FDA, ISO).
• Works with support functions to control and improve equipment efficiencies while minimizing downtime and repair expenses. Implements cost effective systems around this as necessary.
• Serves as an expert for the cobas® Liat filling and pouching process. Must be able to explain the process in detail from start to finish supporting process improvements, technical transfers and resolving deviations. Takes an active leadership role in design and implementation of continuous improvement tools to drive success.
• Leads project-based activities and process improvements to support departmental and company goals. Provides support for timely achievement of overall product or project goals and the expeditious transfer of technologies.
• Collaborate with Quality teams to ensure manufacturing areas maintain compliance and good documentation practices are in effect.
• Writes and/or revises documents (e.g., SOPs, Variances, Rework Orders, Change Requests) to comply with cGMP/ QSR practices.
• Responsible for providing appropriate training on job-specific SOPs and development opportunities to staff in order to achieve their highest potential. Provide timely feedback, both positive and constructive, to ensure on-going progress towards goals and expectations. Set team goals aligned with the company’s objectives.
• Live the RMS Cultural Dimensions and encourage employees to speak up and bring ideas forward.
• Operate with a Servant Leadership mindset. Role modeling standards and behaviors that drive employee engagement and continuous improvement
• Participates in routine training activities to maintain/enhance own technical skill level and supervisory abilities. Seeks and acts on feedback to ensure progress towards goals and expectations.
• Perform any and all additional tasks relating to the operation and success of the manufacturing department as requested.
• Maintains control of work group expenses within limits of DOA.
• Other duties as assigned by management.
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.
Associate's Degree Required
Bachelor's Degree Preferred
4 years of relevant experience in production, manufacturing or related field
Supervisory/management or leading/directing people
Knowledge, Skills and Abilities
In-depth understanding of filling, environmental monitoring, GMP, ISO, QSR requirements.
Excellent critical thinking and problem-solving skills
Ability to communicate effectively and build collaborative relationships
Ability to summarize complex information and present to senior management
Strong knowledge of Trackwise, ERP and MES