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MF Lead Operator - Pali - Windsor Colorado
Company: Tolmar Location: Windsor, Colorado
Posted On: 05/19/2024
DescriptionCore Hours Vary, but Most Production Occurs Between the Hours of 6am - 6pm Key Responsibilities - Perform job responsibilities in accordance with standard operating procedures (SOPs) and production records with an expectation of "Right the First Time".
- Record data in notebooks or lab forms and accurately calculate results to support process.
- 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
- Set up and operate semi-automatic labeling equipment used to label pre-filled syringes.
- Properly load pre-filled syringes and/or vials into labeling equipment.
- Set-up and operate semi-automatic packaging equipment used to package pre-filled syringes.
- Set up and operate semi-automatic filling equipment used to fill syringes for injectable products in both general manufacturing and sterile manufacturing areas.
- Properly load pre-filled syringes and components into semi-automatic packaging equipment.
- Formulate bulk materials.
- Perform facility cleaning of manufacturing areas as required to maintain a cGMP environment and following TOLMAR Standard Operating Procedures.
- Set up and operate compounding equipment used to produce bulk material for injectable products.
- Perform final review of processes before the processes can be considered complete.
- Properly perform job duties as a second checker, ensuring all production activities are correctly performed on batch records in accordance with cGMP standards.
- Assist with equipment steam in place (SIP) on equipment used for sterile bulking processes.
- Ensure that product quality adheres to approved specifications.
- Assist and support any aseptic process development activities/projects as determined by Aseptic Development Operations Manager.
- Handle hazardous raw materials and cleaning solutions following all applicable safety procedures and policies.
- Correctly perform inspections of packaged components.
- Responsible for assembly, disassembly and sanitation of various equipment.
- Train other Manufacturing Operators and Manufacturing Technicians in the Aseptic Development team to perform job duties related to their position.
- Review and maintain log books, production records, and associated documents to comply with regulatory requirements, GMPs, and TOLMAR Standard Operating Procedures.
- Perform visual and physical checks of in-process and finished product as requested.
- Perform biological sampling of general manufacturing clean room facilities.
- Perform 100% inspections of pre-filled syringes.
- Coordinate the daily tasks for Manufacturing Operators and Technicians within assigned process.
- Coordinate materials, staffing and resources to support line operations and changeovers.
- Ensure that employees in assigned process follow safe work practices.
- Perform on floor, in process reviews of production batch records for accuracy and resolve errors in real time.
- Operate under the guidance of a Manufacturing Manager.
- Perform other duties as assigned.
Special Skills and Knowledge - Mastered knowledge of current Good Manufacturing Procedures (cGMP) as they relate to production packaging activities.
- Ability to stand for extended periods of time (up to 8 hours or more).
- Proficient in Microsoft Office (Excel, Word, and Outlook).
- Ability to maintain focus on detail-oriented, repetitive tasks.
- Good verbal and written communication skills.
- Ability to follow and understand written production records and validation protocols.
- Strong understanding of basic math and writing skills to document production activities in batch records and/or log books.
- Ability to keep accurate records and able to perform mathematical calculations.
- Ability to legibly complete required documentation.
- Excellent attention to detail for documentation in production documents and to inspect produced goods within specified requirements.
- Capability to operate on a fast-paced manual assembly line using basic production equipment.
- Ability to learn Aseptic technique and work in an aseptic environment.
- Ability to wear respirator for extended periods of time while working on tasks (up to 4 hours).
- Ability to lift up to 40 lbs.
- Ability to lift arms above shoulder height repetitively for duration of shift while cleaning.
- Ability to provide support as well as direction to Process Development personnel in the area.
- Ability to operate new production equipment with little to no previous experience.
- Ability to lead others in proper aseptic technique and work in an aseptic environment.
- Ability to quickly make decisions and understand the impact on processes and employees.
- Technical ability to assemble and disassemble filing equipment.
- Ability to provide consistent coaching, guidance, development and mentorship to operators and technicians.
Core Values - The Lead Operator - Aseptic Development 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.
- Ability to lead by example and have a proven record of excellence in attendance, dependability and safety.
Education & Experience - High school diploma or equivalent required.
- Engineering degree and/or equivalent previous experience in engineering or process development preferred but not required.
- Three or more years of experience in an aseptic (sterile) manufacturing environment preferred.
Additional Requirements - Acceptable results on both a quantitative and verbal assessment test.
- Valid driver's license and acceptable motor vehicle record may be required.
- Passing results on an internal inspection qualification for syringe inspection on semi-automated equipment for one syringe type.
- Shift work in a manufacturing and warehouse environment.
- Overtime may be required.
Working Conditions - Working conditions are normal for a Manufacturing Environment
Compensation and Benefits |
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