Quality Specialist

Location: Town of Harrietstown
Quality Specialist page is loaded## Quality Specialist remote type:
On-site locations:
Saranac Lake, NYtime type:
Full time posted on:
Posted 4 Days Agojob requisition : R5175## 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:**…