Bulk Processor

Endo International•Rochester, MI

5d•Onsite

About The Position

In accordance with written and oral instructions, operates all products manufacturing equipment required in the preparation of sterile and non-sterile bulk products. This position requires the ability to compound and handle the manufacturing of biological, parenteral, ointments, suspensions, solutions, oils, and crystallized antibiotics. Responsible for performing checks and verifications required, as well as Rx card documentation.

Requirements

High School Diploma, GED or equivalent
Successful completion of certified in-house qualification programs
Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
Must have some mechanical knowledge of operations
Must have the physical ability to perform dispensing operations
Required to reach with hands and arms and frequently required to use hands to finger, handle or feel.
Occasionally lift and/or move up to 50 pounds
Specific vision abilities required by this job include close vision
Frequently exposed to moving mechanical parts
Frequently exposed to toxic or caustic chemicals
The noise level is moderate
Work environment is a production/manufacturing environment

Responsibilities

Compounds bulk solutions, ointments, suspensions, biological, parenteral, oils and crystallized antibiotics
Operates all equipment in the department for the purpose of manufacturing bulk products
Assembles all paper work/raw material/equipment to begin batch Rx
Performs weight, identity, verifications on incoming raw materials before manufacturing
Performs checks and adjusts pH values, dissolved oxygen values, and records temperatures
Maintains the cleanliness and orderliness of work area, equipment, and materials
Maintains identity/segregation of clean and sterilized equipment
Assists in training of new colleagues
Regulates and checks manufacturing equipment before use and notifies supervisor if repairs are needed
Performs Rx card documentation and calculations as required by batch card
Assembles, operates manufacturing equipment (kettles, tanks, filters, Micro fluidizer, mill, contherms)
Receives supplies, raw materials, products in area and moves to designated storage areas
Monitors and changes area system charts (WFI USP/EP, freezer/refrigerators)
Maintains safe working conditions and orderly work area, ensures that all equipment is maintained in safe operating conditions 70%
Performs all functions in accordance with Good Manufacturing Practices and Corporate Regulations
Participates in training programs and observes all required procedures, practices, methods, etc.
Observes all Product Control Procedures and safety and health regulations
Continuous Records documentation on Rx cards and all documentation forms included in batch Rx card (weight ticket, Form 97 6, filter printouts, etc.) 10%
Prepares intermediate solutions, such as Hydrochloric Acid, Sodium Hydroxide, and Phenol 10%
Performs residual tests (equipment, sterile and non-sterile manufacturing rooms)
Performs and verifies filter integrity test
Performs/submits/delivers test laboratory samples 10%
Performs other duties as assigned. Continuous Total 100%