Description

Core Hours

Wednesday - Saturday, 5 : 00 pm - 5 : 30 am; every other Wednesday off

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

• Mastered knowledge of current Good Manufacturing Procedures (cGMP).
• Ability to stand for extended periods of time (up to 8 hours or more).
• Proficient in Microsoft Office (Excel, Word, Outlook).
• Ability to maintain focus on detail-oriented, repetitive tasks.
• Excellent verbal and written communication skills to interact with Supervisors and colleagues.
• Adhere to written production records and validation protocols.
• Strong math and writing skills to document production activities in batch records and / or log books.
• Excellent attention to detail for documentation in production documents and to compare produced goods against specified requirements.
• Capability to operate on a fast-paced manual assembly line using basic production equipment.
• Ability to legibly complete required documentation.

Core Values

• The Lead Operator - Aseptic is expected to operate within the framework of Tolmar's Core Values :
• Consistently operate with the highest standards of ethics and compliance.
• Take ownership of your actions, success and setbacks.
• Respect each other and understand that honest collaboration is at the heart of our company success.
• Go the extra mile to make things happen.
• Be committed to all we do and the patients we serve.
• Embrace change with enthusiasm.
• Strive to learn about and understand the needs of customers and patients, and take action with great speed and efficiency no matter the task.

Communication

• Interact with peers and members of other departments in team settings in a professional manner.
• Provide consistent coaching, guidance, development and mentorship to operators.

Education & Experience

• High school diploma or equivalent required.
• 3 or more years of experience in a GMP manufacturing environment.

Additional Requirements

• Acceptable results on both a quantitative and verbal assessment test.
• Valid driver's license and acceptable motor vehicle record may be required.
• Shift work in a manufacturing and warehouse environment.
• May require overtime.
• Ability to lead by example and have a proven record of excellence in attendance, dependability and safety. Passing results on an internal inspection qualification for syringe inspection on semi-automated equipment for one syringe type.

Compensation and Benefits

• Pay : $30.16 per hour
• Shift differential : $2.50 per hour
• Benefits summary : https : / / www.tolmar.com / careers / employee-benefits

Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package.

Equal Opportunity Employer / Protected Veterans / Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.

However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)

Last updated : 2024-06-04