Manufacturing Lead Operator - Aseptic (1st Shift)

Description

Core Hours

1st shift, Monday - Friday 6 : 00 am - 2 : 30 pm

Purpose and Scope

The Aseptic Lead Operator supervises and leads processes including set-up and operation of processes related to supporting the injectable team, while ensuring that products are made with quality for our patients.

Key Responsibilities

• Perform job responsibilities in accordance with standard operating procedures (SOPs) and production records with an expectation of "Right the First Time".
• Perform job in a clean room environment requiring clean room gowning, including but not limited to :
• Company-provided Scrubs
• Shoe Covers and Sterile Boot Covers
• Hairnets (and beard covers as applicable)
• Tyvek Coveralls
• Gloves
• Full-face masks / hoods
• Goggles
• Chemical Protection PPE
• Setup and manufacture (bulk, fill, stopper, label, and package) clinical supplies and commercial pharmaceutical products in an aseptic environment in accordance with production batch records.
• Set-up and operate semi-automatic filling equipment used to fill syringes for injectable products in both general manufacturing and sterile manufacturing areas.
• Perform routine sampling and inspections of pre-filled syringes for injectable products.
• Set-up and operate compounding equipment used to produce bulk material for injectable products.
• Perform biological sampling of general manufacturing clean room facilities.
• Set-up and operate semi-automatic packaging equipment used to package pre-filled syringes.
• Document production activities using regulatory controlled documents including production records and log books.
• Accurately perform facility cleaning of manufacturing areas as required to maintain a cGMP environment and by TOLMAR Standard Operating Procedures.
• Perform visual and physical inspections of in-process and finished product as requested.
• Responsible for assembly, disassembly and sanitation of various equipment.
• Properly perform job duties as a second-checker, ensuring all production activities are correctly performed per batch production records.
• Responsible for quality of product.
• Train other Aseptic Operators and Technicians in the Injectable Products team to perform job duties related to their position.
• Handle hazardous raw materials and cleaning solutions following all applicable safety procedures and policies.
• Formulate bulk materials.
• Maintain proper use of aseptic techniques.
• Operate under the minimal supervision of a Supervisor.
• Perform other duties as assigned.

Special Skills and Knowledge

Core Values

This position is expected to operate within the framework of Tolmar's Core Values :

Communication

Education & Experience

Additional Requirements

Compensation and Benefits

Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.

Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.

Equal Opportunity Employer / Protected Veterans / Individuals with Disabilities

This employer is required to notify all applicants of their rights pursuant to federal employment laws.

For further information, please review the Know Your Rights notice from the Department of Labor.