Amneal Pharmaceuticals LLC (J0P) Production Operator III in Branchburg, New Jersey
The Production Operator III fulfills a critical role in daily execution of Pharmacy, Mixing, Compression and Coating manufacturing. Performs functions relating to the development and processing of drug products, ensuring product compliance to establish current Good manufacturing Practices (cGMPs), customer requirements and in conjunction with all Standard Operating Procedures (SOPs). Responsibilities include: reading and reviewing relevant sections in study protocols and amendments, and follow directions therein, assist in setting up calculation/verification data prior to study initiation, verify preparation of test materials prior to dose administration, prepare test article/substance dosage solution/suspension(s), perform procedures consistently and record outcomes correctly. The Production Operator III is an experienced level position with minimal direct supervision and oversight by assigned supervisor. This individual is expected to more independently plan and make decisions on defined projects and deadlines set by others and understanding and running processes to meet the assigned schedule.
Performs experiments to pilot/scale-up/ANDA batches, including process optimization of oral dosage form unit operations using FDAs quality by design and well-experimental design approaches.
Runs processes to meet the assigned schedule and standards and when this is not achieved, Analyze data results and reports results to Supervisor.
Able to perform all B stage reconciliation
Plans and makes decisions on defined projects and deadlines set by others and runs processes to meet the assigned schedule
Communicate with good writing and critical analysis skills and present process optimization and trouble-shooting activities, findings and recommendations to supervisors.
Responsible for all applicable documentation, creating and maintaining activity records and requirements.
Perform other job related duties as assigned.
Equal Opportunity Employer-minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity