Production Lead

The Production Lead coordinates activities of workers engaged in operating equipment, producing and/or assembly products in accordance with established quality, time and cost standards. Performs process operations.

Group Lead Duties:

• Maintain product manufacturing within product standards for quality, timeliness and cost.

• Train operator employees on work methods, company policy, procedures and related topics.

• Supervise department employees to ensure goals are met for the company.

• Recommend measures to improve production methods, equipment performance, and quality of product.

• Adhere to all company policies and procedures paying special attention to health and/or safety procedures and FDA regulations.

• Monitor safety standards within corporate guidelines for the production process.

• Maintain time and production records.

• Estimate, requisition, and inspect materials.

• Ensure materials required for each order are available and properly prepared, and order materials as needed.

• Confer with other supervisors to coordinate activities of individual departments.

• Ensure production equipment set up's are completed as required.

• Reports machine and equipment malfunctions to maintenance personnel

• Ensure products are properly packed and shipped in a timely manner.

• Perform other related duties as assigned.

Operator Duties:

• Receive and store product and packaging materials as directed.

• Set up production suites and equipment in accordance written procedures and company standards

• Perform formulation, packaging and inspection operations in accordance with written procedures

• Operate packaging equipment in accordance with written procedures

• Inspect materials and products and report flaws immediately to management

• Detect and report machine malfunctions promptly to management

• Maintain an adequate supply of operating materials for production and obtain additional materials according to procedures

• Document production activities on supplied forms

• Adhere to established company policies and procedures paying special attention to safety regulations and FDA / cGMP standards

• Wear personal protective equipment and clothing in accordance with established procedures and training guidelines

• Conduct cleaning and sanitation operations as described in established procedures. Maintain a neat and orderly workplace at all times

• Prepare orders for shipment according to written shipping orders and established procedures.

• Coordinate the activities of other Operators as assigned by manufacturing management

• Perform other duties as assigned by management.

Qualifications:

• High school diploma or equivalent.

• Prior Operator experience

• Demonstrated knowledge and mastery of FDA regulations, job responsibilities/duties and understanding of the company standards.

• Prior experience in a medical device, pharmaceutical or FDA regulated facility preferred.