Job 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.

Education:

• High School or GED - Required
• Associate Degree - Preferred
• Bachelors Degree (BA/BS) - Preferred

Experience:

• 3 years or more in HS
• 1 year or more in AS
• no experience in BS

Specialized Knowledge:

• Must possess a working knowledge of techniques and equipment related to pharmaceutical manufacturing of solid oral dosage forms, such as granulators, blenders, tablet presses, fluid bed and coating equipment.
• Ability to perform in-process tests such as loss on drying, disintegration bulk, hardness, thickness, friability, weighing
• Knowledge of record experimental procedures, data and findings according to cGMP standards.
• Knowledge of performing calculations required in the batch records
• Understanding and application of cGMP requirements applicable to manufacturing in a pharmaceutical environment.
• Generate and review and generate batch records.
• Knowledge and adherence to applicable state and federal laws and the safe usage of chemicals as identified in the MSDS.
• Proficiency in Microsoft (Word, PowerPoint, Excel)

The hourly rate for this position ranges from $24.00 to $32.00 per hour. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, with this position within the first 12 months. Amneal ranges reflect the Company’s good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life’s many other commitments and opportunities.

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.