The Production Operator II in Operations fulfills a critical role in daily execution of Pharmacy, Mixing, Compression and Coating Manufacturing. Performs functions related 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 following direction therein, assisting in setting up calculation/verification data prior to study initiation, verifying preparation of test materials prior to dose administration and preparing test article/substance dosage solution/suspension(s), performing procedures consistently and recording outcomes correctly.
The Production Operator II is an intermediate level position with limited direct supervision and oversight by assigned supervisor. This individual completes a variety of assignments with direct supervision based on established procedures including executing experiments for defined projects and deadlines set by others.
- Completes a variety of assignments under direct supervision based on established procedures, including performing experiments to pilot/scale-up/ANDA batches and process optimization of oral dosage form unit operations using FDA's quality by design and well-experimental design approaches.
- Communicates with good writing and critical analysis skills and presents process optimization and trouble-shooting activities, findings and recommendations to his/her supervisors.
- Plans and makes decisions on defined projects and deadlines set by others and runs processes to meet the assigned schedule.
- Responsible for all applicable documentation, creating and maintaining activity records and requirements.
- High School or GED - Required
- Associate Degree - High School or Above - Preferred
- 2 years or more in Pharmaceutical development and manufacturing. - Required
Skills and Abilities
- A strong working knowledge of cGMP compliance. - Intermediate
- 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. - Intermediate
- Team-oriented with the flexibility to adapt to changing work priorities. - Advanced
- Willingness to work flexible hours, including weekends, as needed. - Advanced
- 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.
- Ability to 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.
- Must possess good computer skills.