Under close supervision, responsible for operating complex equipment, maintaining accurate documentation and completing basic set-up of equipment. This is the journey level of professional development in the Career Ladder System.
Essential Job Functions:
This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform all duties listed, and may be required to perform additional, position-specific tasks.
- Carries out responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws.
- Verifies batch components.
- Conducts in-process testing.
- Operates major equipment independently, as defined.
- Maintains records of manufacturing process by recording statistics on batch record.
- Communicates effectively with previous and incoming shift operator and related personnel.
- Applies math skills to make calculations in Batch Record.
- Works in teams to ensure proper room and equipment set-up and cleaning.
- Checks and adjusts calculations.
- Performs reconciliations.
- Understands concept of delivery/on-time production.
- Verifies and ensures correct set-up of minor equipment as defined.
- Performs quality checks.
- Ensures project deadlines and performance standards are established and met.
- Performs related duties as assigned.
Required Knowledge and Skills:
Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements.
Business English usage, spelling, grammar and punctuation.
Business and personal computer hardware and software applications.
Equipment, process rooms and manufacturing area SOPs and GMPs.
Record keeping skills.
Basic mathematical calculation and measurement methods and practices.
Current Company policies and practices, including safety rules and regulations.
- Communicating clearly and concisely, both orally and in writing.
- Ability to read, write and understand documentation in English.
- Establish and maintaining cooperative working relationships with others.
- Providing excellent customers service with both internal and external customers.
- Working independently as well as in a group.
- Managing multiple projects, duties and assignments.
- Interpreting and applying Federal, state and local policies, procedures and regulations.
Physical Requirements and Working Conditions:
Incumbents in this class are subject to extended periods of sitting, standing, walking, pushing and pulling, stooping and crouching climbing and walking, vision to monitor, occasional lifting of equipment or materials weighing up to 50-70 pounds. Work is performed in a manufacturing environment with moderate to loud noise levels. Work performed may require the use of a respirator and incumbents may be subject to a Pulmonary Function Test (PFT) to determine eligibility for fit-testing.
High School diploma or equivalent, and minimum of two (2) or more years experience, preferably in pharmaceuticals, cosmetics or food industry; or an equivalent combination of education and experience.