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Bionique Testing Laboratories · 2 hours ago

Quality Specialist

Saranac Lake, NY

Full-time

Onsite

Mid Level

$60K/yr - $70K/yr

3+ years exp

Bionique Testing Laboratories is a leading global provider of mycoplasma testing services for the biopharmaceutical industry. They are seeking a highly motivated and detail-oriented Quality Specialist to ensure the integrity of sterility and endotoxin testing services, support regulatory compliance, and facilitate the adoption of new testing methodologies.

BiotechnologyHealth CareInformation Technology

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

Qualification

Microbiological quality controlRegulatory complianceCGMP experienceMethod validationAseptic processingEnvironmental monitoringAnalytical skillsMicrosoft Office SuiteQuality systemsCommunicationTeam playerAttention to detail

Required

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)

Strong understanding and knowledge of USP, USP, USP, USP, 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)