Job Summary

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

Work Experience

• 3 years or more - HS - Preferred
• 1 year or more - AS - Preferred
• No experience - BS - Preferred

Skills and Abilities

• Have a strong working knowledge of cGMP compliance - Intermediate
• Possesses advanced technical skills, time management and communication competencies, and a commitment to innovation and efficiency. - Intermediate
• Excels at training, mentoring, and supervising junior technical professionals. - Intermediate
• Is up-to-date on recent advances of manufacturing equipment and operation. - Intermediate
• Strong communication and problem-solving skills. - Advanced
• Team-oriented with the flexibility to adapt to changing work priorities. - Advanced
• Willingness to work flexible hours, including weekends, as needed. - Advanced

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)