This is a 3rd shift position (11:00pm-7:30am) with overtime required per business need.
Coordinates the production activities for filling and packaging lines. Operates filling and packaging equipment. Receives direction from Team/Group Leader on production plan. This position requires Aseptic Gowning certification (where applicable), QC certification, ERPLx certification, Visual Inspection certification, and Line Clearance/LOTO certification. Evaluates quality issues with the quality representative. Assumes responsibility for the GMP, ISO, environmental health and safety procedure awareness, and compliance within the respective area. Participates in improvements for material variance, quality indicators, and line efficiencies. Provides feedback to team/group leaders regarding associate performance and behaviors.
Assigns tasks for manufacturing operations and support associates. Coordinates and performs the set-up and changeover of manufacturing equipment. Verifies component readiness, line clearances, and product returns. Maintains equipment and line cleanliness and compliance (audits).
Operates filling and packaging equipment for the manufacturing of drug product.
Completes all documentation accurately (review batch records/ERPLx transactions).
Performs initial and ongoing training and development of associates.
Accountable for the operations occurring in the line(s) assigned.
HS Diploma/GED required or BA/S preferred
Leadership experience preferred. Basic math skills, detail oriented, excellent communication skills and demonstrated leadership ability. Ability to effectively work with different department supervisors. Ability to operate manufacturing equipment. Strong knowledge of the manufacturing process as well as manufacturing performance and financial attributes such as material variance, yield, and efficiencies.
Must be able to read, write and speak English and possess basic math skills.