Hybrid Quality Analyst bei AKAmerica

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 30 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 developing and supporting the Quality Department, ensuring regulatory compliance and the reliable maintenance of quality standards throughout the organization.   

Key Accountabilities and Responsibilities:

• Reviews/audits documents and daily reports as assigned

• Communicates completed sample test reports to clients as requested

• Creates, distributes and reconciles controlled documents

• Supports the maintenance of quality standards of raw materials and products

• Participates in the technical inspection of the facility and proactively communicates areas for improvement

• Reviews and files all Quality documents

• Coordinates on and offsite storage of documents, recall of documents for destruction and contacting clients prior to destruction

• Participates in continuous monitoring of new and existing equipment

• Monitors, maintains, calibrates and maps various scientific tools and equipment

• Responsible for battery and alarm testing, battery replacement, etc.

• Fluent in articulating Quality philosophy to colleagues within the organization

• Actively participates in and supports capital improvement projects

• Prepares the shipment of equipment for calibration

• Responsible for Environmental Monitoring (EM) of laboratory spaces

• Manages the implementation and execution of IQ/PQ processes of lab equipment

• Additional duties as assigned

Additional Accountabilities and Responsibilities:

• Ability to adhere to standard timeline 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

Requirements:

• Bachelor’s degree from an accredited college/university in a relevant field; experience or combination of experience with degree may be substituted for Bachelor’s degree requirement

• Ability to handle multiple tasks and projects under deadline pressure

• Able to adapt quickly to change

• Strong organizational and time management skills

• Highly analytical with strong attention to detail

• Excellent verbal and written communication skills

• A results-oriented team player

• Proficient with Microsoft Office Suite or related software

Physical Requirements:

• Prolonged periods of sitting on a chair, working at a desk and working on a computer and/or telephone

• Must be able to lift up to 25 pounds

Pay Rate and Work Shift:

• The base compensation range for this role is $21.63/hour

• The work hours for this position are 10AM - 6PM

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.

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