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