Summary:

Ensures that work performed is accurate, timely, efficient and compliant with corporate policies, plant SOPs, cGMP regulations, and FDA regulations. Operates, disassembles, cleans, and reassembles all processing equipment as assigned. Performs material preparation and facility cleaning as required. Participates in investigations and continuous improvement initiatives to improve quality, cost, safety and/or cycle time. Collaborates effectively with other functional groups to ensure production goals are achieved and investigations are completed in a timely manner.

ESSENTIAL FUNCTIONS

Essential functions include, but are not limited to, the following:

• Act at all times in line with the Company values, particularly leadership, integrity and respect for people.
• Accurate execution of assigned tasks in the performance of daily operations.
• Maintains a safe and cGMP compliant work environment.
• Execution of batch records and documentation throughout the manufacturing/inspection/ packaging process to ensuring timely and accurate entries.
• Communicates and ensures adequate material supply in anticipation of production needs.
• Performs inventory transactions as required per the production schedule.
• Coordinates activities with the other departments to assure timely execution and delivery of finished product.
• Ensures compliance with all government and company regulatory requirements.
• Ensures application of cGMP compliance with respect to operations and documentation.
• Provides training to other staff members as necessary to assure compliance and maintain quality requirements.
• Performs verification as required in batch documentation as an independent resource.
• Participates in continuous improvement initiatives to improve quality, cost, safety and cycle time.
• Able to handle routine problems independently. Works with cross-functional experts in solving problems.
• Reviews, updates, and revises SOP's.
• Maintain cleanliness and orderliness of manufacturing areas.
• Maintains manufacturing documentation/areas in a audit ready state
• Other duties as assigned by Production Management.

Qualifications:

Must have 0 to 5 years manufacturing experience.

Education:

High school education or equivalent.

OTHER KNOWLEDGE AND SKILLS REQUIRED:

cGMP's, SOP's, Safety OSHA, FDA/CBER regulations, company polices.
Attention to detail, conscientious and a good communicator oriented to providing customer service.
Ability to lift 50 pounds.
Committed to team effort and be willing to periodically assist in unrelated job areas.