Manufacturing Product & Packaging Operator III at Amneal India

Piscataway, New Jersey, United States -

Full Time

Start Date

Immediate

Expiry Date

26 Aug, 26

Salary

32.0

Posted On

28 May, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Pharmaceutical Manufacturing, Process Optimization, cGMP Compliance, Data Analysis, Documentation, Communication, Critical Analysis, Microsoft Office

Industry

Pharmaceutical Manufacturing

Description

Description: 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. Essential Functions: * Performs experiments to pilot/scale-up/ANDA batches, including process optimization of oral dosage form unit operations using FDA’s 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. Additional Responsibilities: * Responsible for all applicable documentation, creating and maintaining activity records and requirements. * Perform other job related duties as assigned. Amneal is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws. If you require a reasonable accommodation to complete the application process or to participate in any part of the hiring process, please contact us at accommodations@amneal.com. Requests will be handled confidentially and in accordance with applicable laws.

Responsibilities

The Production Operator III is responsible for executing daily manufacturing processes in Pharmacy, Mixing, Compression, and Coating. This includes ensuring compliance with cGMPs and SOPs while independently planning and making decisions on defined projects.