Quality Specialist

Asahi Kasei•Saranac Lake, NY

35d•$60,000 - $70,000

About The Position

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.

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)
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)

Nice To Haves

Experience supporting method development or validation for new testing services is strongly preferred

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
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