The Asahi Kasei Group operates with a commitment of creating for tomorrow.  Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.

Bionique Testing Laboratories LLC (Bionique) has been a leading global provider of mycoplasma testing services for the biopharmaceutical industry for over 35 years. Bionique offers the full breadth of services from lot and Final Drug Product release testing per regulatory guidelines to a GMP compliant Real-Time PCR assay to support clients’ needs from concept to clinical trials and commercialization for biopharmaceutical and cell therapy products. Bionique’s experience and expertise extends to development and validation of rapid microbiological methods to support abbreviated release timelines. Additional services such as regulatory and compliance consultancy add to Bionique’s unique position in this niche analytical testing space. Located in Saranac Lake, NY, Bionique is an FDA registered and GMP compliant contract testing facility. Bionique aims to offer unsurpassed quality mycoplasma testing services to meet the specific scientific and regulatory needs of each client and partner.

Company:

Bionique Testing Laboratories LLC

Job Description:

Summary:

This position is responsible for assisting laboratory personnel and supporting the quality control, sterility control and safety agenda of the organization with various functions within the facility. The Laboratory Assistant is responsible for maintaining a clean and sanitary environment, adhering to strict protocols and regulations. Their duties include cleaning, sanitizing, and disinfecting surfaces, equipment, and rooms, following regulations and Standard Operating Procedures (SOPs). They also manage inventory of cleaning supplies, document their work, and report any deviations or safety concerns.

Key Accountabilities and Responsibilities:

• Perform routine and specialized cleaning tasks in GMP areas, including sweeping, mopping, vacuuming, waste disposal, recycling, dusting, and disinfecting surfaces, equipment and rooms, throughout the laboratory areas according to established cleaning schedules and in compliance with regulations, GMP standards, and Company Standard Operating Procedures (SOPs)
• Adhere to safety guidelines and using cleaning products and equipment safely, including wearing appropriate Personal Protective Equipment (PPE) when required
• Wash, dry, and sterilize glassware and distribute to appropriate locations within the laboratory, keep glass-washing area clean and organized; may sterilize glassware and other items using an autoclave
• Accurately record all cleaning activities, including the use of specific cleaning agents and the completion of required documentation, to maintain a clear audit trail
• Operate designated laboratory support equipment and perform assigned equipment cleaning and routine maintenance activities in accordance with established schedules, applicable SOPs, and completed training
• Monitor and maintain cleaning and laboratory inventory levels and communicate replenishment needs in accordance with established inventory management processes
• Receive and stock assigned areas with laboratory supplies and reagents
• Perform assigned cleaning, equipment maintenance, and laboratory support activities according to established schedules, cadences, and task lists and accurately document completion
• Report any maintenance issues, equipment deficiencies, or unusual situations to supervisors.
• Work effectively with other teams, such as Quality, various laboratory personnel, Administration, and Facilities, to coordinate cleaning schedules and address any issues.
• Remain up to date with assigned training
• Additional duties as assigned

Requirements:

• Works independently and proactively
• Promotes process improvement
• Ability to adhere to standard timelines and escalate actions appropriately for resolution in a timely manner
• Keeps manager informed of progress and communicates effectively with colleagues as necessary to achieve assigned tasks and goals
• Performs jobs responsibilities as directed and completes tasks as assigned

Qualifications:

• Prior cleaning experience in a GMP, laboratory, or other sterile environment preferred
• Ability to handle multiple tasks under deadline pressure
• Able to adapt quickly to change
• Strong organizational and time management skills
• Ability to read, write, and comprehend written and verbal instructions, including safety procedures and SOPs.
• Proficient with Microsoft Office Suite or related software

Physical Demands and Work Environment:

• Ability to sit on a chair, work at a desk/bench, and work on a computer and/or telephone
• Pushing/Pulling/Lifting up to 50 pounds
• Standing/Walking/Mobility: must be able to stand to operate office and laboratory equipment for prolonged periods; mobility to move between offices and colleagues required
• Kneeling/Squatting/Sitting: must be able to perform these duties for a prolonged period while cleaning
• Must be comfortable working periodically on various sized ladders up to 6 feet high.
• Candidates must have reliable means of transportation, as public transportation is not available
• Must successfully pass a pre-employment physical and medical evaluation; specific immunizations may be required
• Must be able to wear required personal protective equipment (PPE), including fitted respirators

Compensation and Shift Information:

• The base compensation range for this role is $19.00/hr - $20.00/hr
• During initial training, the shift for this position will be 9AM – 5PM; once initial training is completed, ability to work evenings hours is required – specific schedule to be determined with the prospective employee

As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.