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 commercial manufacturing operations for solid oral dosage forms, including granulation, blending, compression, and coating, in accordance with approved batch records, SOPs, cGMP requirements, and established manufacturing processes.
- Runs assigned manufacturing processes to meet established production schedules, quality standards, and operating requirements. Identifies and evaluates process issues or deviations, analyzes relevant data, and promptly communicates findings to the Supervisor.
- Able to independently perform all B-stage reconciliation activities accurately and in accordance with established SOPs, batch records, and cGMP requirements.
- Plans and prioritizes assigned activities and independently executes manufacturing processes to meet established production schedules and deadlines.
- Analyzes manufacturing process issues, supports troubleshooting activities, and effectively communicates findings, observations, and recommended actions to supervisors.
- Perform and accurately document in-process testing, including loss on drying (LOD), disintegration, bulk density, tablet hardness, thickness, friability, and weight testing, in accordance with established procedures and cGMP requirements.
Additional Responsibilities:
- Responsible for all applicable documentation, creating and maintaining activity records and requirements.
- Perform other job related duties as assigned.
Qualifications
Education:
- High School or GED - Required
Experience:
- 3+ years of experience in pharmaceutical manufacturing, preferably in solid oral dosage manufacturing, with hands-on experience in operations such as granulation, blending, compression, fluid bed processing, and coating.
Specialized Knowledge:
- Demonstrated knowledge and hands-on experience with pharmaceutical manufacturing processes and equipment used to produce solid oral dosage forms, including granulation, blending, tablet compression, fluid bed processing, and coating.
- Knowledge of cGMP documentation requirements and the ability to accurately record manufacturing activities, process data, and in-process results.
- 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 batch records.
- Knowledge of and adherence to applicable safety regulations and requirements, including the proper handling and safe use of chemicals in accordance with Safety Data Sheets (SDS) and established site procedures.
- Proficiency in Microsoft (Word, PowerPoint, Excel)
The hourly rate for this position ranges from $23.50 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.
