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:

We are seeking a highly motivated and detail-oriented Quality Specialist to join our cGMP-compliant testing facility. This role is critical in ensuring the integrity of our sterility and endotoxin testing services, supporting regulatory compliance, and facilitating the adoption of new testing methodologies. The ideal candidate will have a strong background in microbiological quality control, regulatory affairs, and continuous improvement within a pharmaceutical or biopharmaceutical environment.

Key Accountabilities and Responsibilities:

• Documentation Review and Approval: Review and approve Quality Control (QC) documentation, including test data, logbooks, equipment qualification records, and test reports for our routine and new testing services that include mycoplasma, sterility, and endotoxin testing.
• Batch Record Review and Product Release: Perform timely review of batch production records and associated quality event documents to support the release of finished sterile products.
• Auditing and Compliance:
  • Responsible for ensuring protocols & reports, validation qualification studies, process changes, and new services and products validation meet industry standards and regulatory requirements
  • Participate in and/or support internal, external, and regulatory audits (e.g., FDA, EP, JP) as a subject matter expert for microbiology and sterility assurance ensuring testing activities comply with CGMP, USP, EP, and other applicable regulatory standards.
• Deviation and CAPA Management: Collaborate with investigation teams to manage quality events, deviations, Out-of-Specification (OOS) results, and complaints related to sterility assurance. Lead or support root cause analysis investigations, risk assessments, and the development/approval of Corrective and Preventive Actions (CAPAs).
• SOP Development and Revision: Develop, maintain, revise, and approve Standard Operating Procedures (SOPs), appendices, technical documents, and other controlled documents impacting sterility assurance, laboratory practices, and the overall Quality Management System.
• Environmental Monitoring (EM) Oversight: Analyze data from environmental and utility monitoring programs to identify trends, establish alert/action levels, and ensure the contamination control strategy (CCS) is effectively implemented and compliant with guidance documents.
• Validation Support: Review and approve validation protocols and reports for sterilization processes, test methods, and equipment.
• Interdepartmental Support:
  • Provide Quality support for sterility and endotoxin testing, including method validation, routine testing, and troubleshooting.
  • Collaborate with laboratory teams to ensure accurate and timely execution of testing procedures.
  • Assist in the evaluation and implementation of new testing services and technologies.
  • Training and Mentorship: provide training and guidance to staff on Quality standards, aseptic techniques, and regulatory requirements
• Maintain professional and technical knowledge of regulatory requirements and industry best practices related to endotoxin, sterility, and other new microbiological testing.
• Continuous Process Improvement: Identify and implement process improvements to enhance quality and efficiency.
• Report Generation: generates reports and presents/analyzes metrics related to assigned projects as needed
• Supports commissioning and equipment validation/qualification
• Supports Quality and operational metrics review such as track and trending analysis
• Reviews testing records as needed
• May represent Bionique’s Quality Department at various internal and external meetings
• Communicates effectively with internal personnel as well as external customers
• Investigate and troubleshoot problems, determining solutions or recommendations for changes and/or improvements.
• Perform additional duties as assigned

Additional Accountabilities and Responsibilities

• Works independently and proactively
• Proactively communicates progress and furthers understanding amongst colleagues and supervisors
• Highly organized and delivers on commitments without reminders
• Driven to continuously improve individual work and departmental processes
• Handles recurring issues with comfort and escalates new ones appropriately
• Ability to independently assess impact and retesting requirements in the event of a deviation
• Possesses working knowledge of regulatory environment and industry standards
• Accurately performs quality reviews of items as requested
• May serve as a delegated backup for senior staff when requested
• Strong critical thinking and problem-solving skills required

Requirements:

• Bachelor’s degree from an accredited college/university in microbiology, biology, biotechnology, chemistry, or related scientific field; experience or combination of experience with degree may be substituted for Bachelor’s degree requirement
• 3 years’ experience in a cGMP-regulated environment, preferably in a microbiological testing or quality role
• Regulatory knowledge for sterility and endotoxin testing required (e.g. LAL assays, membrane filtration)
• Experience supporting method development or validation for new testing services is strongly preferred
• Familiarity with aseptic processing and cleanroom environments is preferred
• Strong understanding and knowledge of USP <71>, USP <72>, USP <85>, USP <86>, and other regulatory guidelines (FDA, EMA, ICH)
• Ability to handle multiple tasks and projects under deadline pressure
• Able to adapt quickly to change
• Ability to work cross-functionally in a fast-paced, regulated setting
• Highly analytical with strong attention to detail
• Excellent documentation, organizational, verbal and written communication skills
• A results-oriented team player
• Proficient with Microsoft Office Suite and Quality systems (e.g. LIMS, QMS)

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 50 pounds

Pay Rate:

• The base compensation range for this role is between $60,000/yr - $70,000/yr. The actual compensation is commensurate with experience.

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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.