Quality Analyst

Asahi Kasei•Harrietstown, NY

1d•Onsite

About The Position

The Asahi Kasei Group, through its Bionique Testing Laboratories LLC subsidiary, is seeking a Quality Analyst. Bionique has been a leading global provider of mycoplasma testing services for the biopharmaceutical industry for over 35 years. Bionique offers a full breadth of services, from lot and Final Drug Product release testing per regulatory guidelines to a GMP compliant Real-Time PCR assay, supporting clients from concept to clinical trials and commercialization for biopharmaceutical and cell therapy products. Their expertise extends to the development and validation of rapid microbiological methods to support abbreviated release timelines, and they also provide regulatory and compliance consultancy. Located in Saranac Lake, NY, Bionique is an FDA registered and GMP compliant contract testing facility, committed to offering unsurpassed quality mycoplasma testing services to meet specific scientific and regulatory needs. This position is responsible for developing and supporting the Quality Department, ensuring regulatory compliance and the reliable maintenance of quality standards throughout the organization.

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
Candidate must be willing and independently able to travel to multiple site locations

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
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