VBeyond Corporation
Job Title -Line Leader
Location -Central Islip, NY
Employment Type -Full Time
Work Hours/ Shift/ Remote -3:00pm -11:30 pm
Benefits In addition to a fulfilling career and competitive salary, the Company offers a comprehensive benefits package to include a 401(k) savings plan and matching, health insurance – medical/dental/vision, health savings account (HSA), flexible spending account (FSA), paid time off (PTO) – vacation/sick/flex time, paid holidays, short-term disability (STD), long-term disability (LTD), parental leave, paid and unpaid family leave, employee discounts, and other benefits.
Responsibilities/ Accountabilities Organize and oversee the activities related to the manufacturing of tablets and capsules to include delivery, in-process samples in a defined schedule. Review and compile the documents generated during the production of tablets and capsules such as Batch Manufacturing Record (BMR), PQ protocol. Perform SAP entry during and finish batches product. Make equipment part list required for machine, and support supervisor to order it Assign work to operators according to product schedule. Make sure to transfer request of product material batches from warehouse to Manufacturing and vice versa. Update attendance. Ensure and compliance with safety, quality, productivity, and performance expectations and execution of manufacturing operations. Review batch record after finishing each step for correctness. Provide support to the operators in regarding day-to-day production activities such as trouble shooting and other work tasks. Make sure correct ness of product log in and yield of product with BMR Correctness online. Schedule cleaning validation with request as required for equipment. Work with Integrated Product Development (IPD)/R&D on the execution of bio-batches (abbreviated new drug applications - ANDA) and validation batches. Support supervisor as needed to day-to-day activity to achieve productivity and compliance. Coordinate to implementation of current good manufacturing practices (cGMP) and safety practices in the operations and manufacturing of products. Ensure to maintain cleanliness working environment. Work closely with Manufacturing Supervisor for Driving operational excellence and flawless execution in order to achieve site quality and manufacturing objectives.
Education Qualifications High School Diploma (or equivalent experience)
Experience Minimum three years of direct work experience in pharmaceutical manufacturing. Preference will be given to candidates with experience in generic pharmaceutical manufacturing.
Skills/ Competencies Must have legible handwriting, and the ability to perform accurate documentation. Understanding of granulation, compression, coating, and encapsulation machines. Capable of conducting troubleshooting, investigations and root cause identification and analysis. Able to prioritize, plan and work under tight schedules and deadlines. Must possess strong documentation and technical writing skills and be able to apply relevant scientific principles and practices. Must communicate clearly and concisely across levels, both orally and in written. Strong command over written and verbal English is required.
Physical Requirements Should not have any restriction to work with powder containing active pharmaceutical ingredients. This position requires the ability to do heavy lifting / bending frequently. Long periods of standing up/walking during the working hours; ability to ascend/descend ladders; and able to lift to 35 pounds. Must be able to move pallets/equipment weighing about 200 – 300 kgs using suitable moving equipment like pallet jacks.
Benefits In addition to a fulfilling career and competitive salary, the Company offers a comprehensive benefits package to include a 401(k) savings plan and matching, health insurance – medical/dental/vision, health savings account (HSA), flexible spending account (FSA), paid time off (PTO) – vacation/sick/flex time, paid holidays, short-term disability (STD), long-term disability (LTD), parental leave, paid and unpaid family leave, employee discounts, and other benefits.
Responsibilities/ Accountabilities Organize and oversee the activities related to the manufacturing of tablets and capsules to include delivery, in-process samples in a defined schedule. Review and compile the documents generated during the production of tablets and capsules such as Batch Manufacturing Record (BMR), PQ protocol. Perform SAP entry during and finish batches product. Make equipment part list required for machine, and support supervisor to order it Assign work to operators according to product schedule. Make sure to transfer request of product material batches from warehouse to Manufacturing and vice versa. Update attendance. Ensure and compliance with safety, quality, productivity, and performance expectations and execution of manufacturing operations. Review batch record after finishing each step for correctness. Provide support to the operators in regarding day-to-day production activities such as trouble shooting and other work tasks. Make sure correct ness of product log in and yield of product with BMR Correctness online. Schedule cleaning validation with request as required for equipment. Work with Integrated Product Development (IPD)/R&D on the execution of bio-batches (abbreviated new drug applications - ANDA) and validation batches. Support supervisor as needed to day-to-day activity to achieve productivity and compliance. Coordinate to implementation of current good manufacturing practices (cGMP) and safety practices in the operations and manufacturing of products. Ensure to maintain cleanliness working environment. Work closely with Manufacturing Supervisor for Driving operational excellence and flawless execution in order to achieve site quality and manufacturing objectives.
Education Qualifications High School Diploma (or equivalent experience)
Experience Minimum three years of direct work experience in pharmaceutical manufacturing. Preference will be given to candidates with experience in generic pharmaceutical manufacturing.
Skills/ Competencies Must have legible handwriting, and the ability to perform accurate documentation. Understanding of granulation, compression, coating, and encapsulation machines. Capable of conducting troubleshooting, investigations and root cause identification and analysis. Able to prioritize, plan and work under tight schedules and deadlines. Must possess strong documentation and technical writing skills and be able to apply relevant scientific principles and practices. Must communicate clearly and concisely across levels, both orally and in written. Strong command over written and verbal English is required.
Physical Requirements Should not have any restriction to work with powder containing active pharmaceutical ingredients. This position requires the ability to do heavy lifting / bending frequently. Long periods of standing up/walking during the working hours; ability to ascend/descend ladders; and able to lift to 35 pounds. Must be able to move pallets/equipment weighing about 200 – 300 kgs using suitable moving equipment like pallet jacks.