What are the responsibilities and job description for the Quality Compliance Specialist position at Asahi Kasei America Inc?
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 ensuring a state of continuous GMP compliance of Bionique's services and activities. This requires a combination of regulatory knowledge, attention to detail, effective communication, and a commitment to continuous improvement with the goal of achieving compliance to applicable regulatory requirements and obligations throughout the organization and ensuring that appropriate control measures are in place.
Key Accountabilities and Responsibilities :
- Effectively communicates and proactively seeks resolution to compliance matters in accordance with internal and regulatory requirements
- Communicates the status of unresolved compliance matters to stakeholders
- Ensures the completion of review / audit of daily reports including, but not limited to final reports, protocols, and nonconforming event reports
- Oversees controlled Quality documents
- Identifies areas for improvement to policies and processes, assesses effectiveness of current policies and processes, and recommends changes
- Provides professional and objective feedback to authors, study directors, technicians, and supervisors on quality and regulatory matters
- Drafts, revises, and approves SOPs
- Manages OOS and deviation events including but not limited to CAPA response reports, client notification, including tracking and reporting of OOS and deviations
- Manages customer complaints including but not limited to investigating and communicating CAPAs to effected parties
- Conducts and / or supports internal audits, client audits, and regulatory audits including, but not limited to coordinating audit scheduling, audit preparation, audit execution, audit response / resolution, and audit follow-up
- Establishes and maintains Quality agreements with clients and suppliers
- Supports education and training on the business on compliance awareness developing and providing quality training, including, but not limited to, GMP orientation, ongoing quality training, and annual regulatory training
- Conducts and / or supports Risk Assessments
- Prepares, maintains, analyzes, and presents metrics related to the quality systems and for tracking regulatory compliance of operations
- Builds collaborative team environment within the department and amongst other company departments
- Leads projects and implements quality initiatives in line with department and organizational goals
- Completes and reports on assignments within the agreed upon timeframe
- Trains and mentors department personnel
- Remains current in the field by review of relevant regulatory and compliance literature and attendance at appropriate seminars and conferences.
- Additional duties as assigned
Additional Accountabilities and Responsibilities :
Requirements :
Physical Requirements :
Pay Rate :
LI-MG1
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.
Salary : $60,000 - $80,000
