Job Title

2nd shift Line Leader - Encapsulation

Organization Name

InvaGen Pharmaceuticals, Inc.

Location

Central Islip, NY

Employment Type

Full Time

Salary Range

(Base/salary)

$ 20.50 - $25.00 p/h

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.

Work Hours/ Shift/ Remote

3-11:30 pm

OT until 1 am.

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.