QC Stability Coordinator Assistant

Résumé du poste

The QC Stability Coordinator Assistant is responsible for maintaining the stability program, including managing sample inventory and monitoring stability chambers. They will also assist in data review, trending, and the preparation of stability reports for regulatory submissions.

Détails du poste

About Bora Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing, and packaging of complex oral solid dose, liquid, semi-solid, biologics, and sterile injectable pharmaceutical products. From our world-class sites in North America and Asia, we deliver drug products with unparalleled quality to more than 100 markets around the world. Bora’s teams, technologies, and facilities work seamlessly together to enable our clients to deliver much-needed therapeutics to patients worldwide. At Bora Pharmaceuticals, we see it as our mission, our duty, our responsibility, to make our success and our customer’s success more certain. Position Status This is a 12-month fixed-term contract (FTC) and a backfill position. The role is an active, approved vacancy within the organization and is intended to support current staffing needs. General Description Participate in organization and maintenance of the stability program. Work to achieve compliance with global regulatory and customer requirements for stability. Ensure samples are set down and pulled from stability chambers within required testing windows and provide written stability reports to customers. Key Responsibilities Help to create and maintain stability protocols. Maintain the stability chamber stability sample inventory and routinely monitor chamber performance. Ensure remaining samples from completed stability studies are appropriately disposed as per local procedures. Assist in stability data review and trending of results upon completion of timepoint testing. Participate in preparation of stability reports according to agreed schedule/due dates for US FDA annual reports, Canadian submission and ROW countries. Perform stability pulls according to the stability pull-schedule. Check production schedules for batches to be set down. Ensure that laboratories aware of incoming stability batches for testing and monitor the execution status. Labware pull check 3 times every week . Preparation of sample for stability study. Stability report data check. Experience & Skills 1-3 years of pharmaceutical experience with the knowledge of cGMP, ICH and FDA stability guidelines. Excellent written and oral communication skills. Hands-on lab testing experience is an asset. Extensive computer experience including LIMs software, SAP, Statistical programs, MS Word and Excel. Experience in the evaluation of analytical data, including statistical interpretation of stability data. Good overall knowledge of pharmaceutical business operations. Education Required: College diploma/certificate in Chemistry. Computer proficiency for MS Word & MS Excel. GMP and GLP experience / knowledge. Preferred: Bachelor of Science degree in Chemistry. Working Conditions Working within chemistry and microbiology laboratories as well as production. Combination of desk work and working within the stability chambers. Overtime work could be required as per business needs. 37.5 hour work week. Light lifting. Additional Information In accordance with Ontario’s pay transparency requirements, candidates will be notified when they are no longer under consideration or once the vacancy is closed. Updates regarding application status may be communicated via email or through the online applicant profile, where applicable. As part of our recruitment process, we may use technology-assisted tools, including automated systems, to support the review and assessment of applications. These tools do not make final hiring decisions. All decisions related to screening, interviewing, and selection are made by our Talent Acquisition and hiring teams. Compensation Range $46,430 - $58,040 Benefits Include: We offer a comprehensive benefits package designed to support our employees’ wellbeing, including: - Competitive salary and performance-based incentives - Comprehensive health coverage including medical, dental, and vision insurance - Retirement savings plans with employer contributions - Paid time off and flexible work arrangements - Professional development opportunities - Employee wellness programs and resources - Employee Assistance Program and Mental Health Resources At Bora, our values guide everything we do — from how we solve challenges to how we support our people. We lead with a solutions-first mindset, strive to do the right thing, stay proactive, and above all, respect everyone. We’re proud to be an equal opportunity employer, committed to building a diverse and inclusive workplace where everyone feels empowered to contribute and grow. We welcome applications from qualified individuals of all backgrounds, experiences, and perspectives. If you require accommodation during any stage of the application or interview process, or if you’d like to learn more about our accessibility policies, please contact us at accessibility@bora-corp.com.

Ce que vous ferez

The QC Stability Coordinator Assistant is responsible for maintaining the stability program, including managing sample inventory and monitoring stability chambers. They will also assist in data review, trending, and the preparation of stability reports for regulatory submissions.

Exigences

Candidates must have 1-3 years of pharmaceutical experience with knowledge of cGMP, ICH, and FDA guidelines. A college diploma or certificate in Chemistry is required, with a Bachelor of Science in Chemistry preferred.

Avantages

• Competitive salary • Performance-based incentives • Medical insurance • Dental insurance • Vision insurance • Retirement savings plans • Paid time off • Flexible work arrangements • Professional development opportunities • Employee wellness programs • Employee Assistance Program • Mental Health Resources

Compétences indiquées

• SAP · Souhaitée
• Regulatory Compliance · Souhaitée

Autres compétences pertinentes

Relevées dans la description du poste. Confirmez les exigences importantes ci-dessus.

• Stability testing
• cGMP
• ICH guidelines
• FDA stability guidelines
• Laboratory testing
• LIMS software
• SAP
• Statistical analysis
• Data review
• Stability reporting
• Sample inventory management
• Regulatory compliance
• Chemistry
• Microbiology
• MS Word
• MS Excel
• Good Laboratory Practice (GLP)
• Workplace Inclusivity
• Customer Success Management
• Business Operations
• Time Off Management
• Microsoft Word
• Microsoft Excel
• Biopharmaceuticals
• Good Manufacturing Practices
• Packaging And Labeling
• Laboratory Information Management Systems
• Laboratory Testing
• Pharmaceuticals
• SAP Applications
• Verbal Communication Skills
• Vision Insurance

Domaines d’emploi

• Science & Research
• Manufacturing
• Healthcare
• Stability Coordinator
• Quality Assurance Supervisor
• Management and Organization Analysts
• Quality Control Systems Managers
• Industrial Production Managers