Manager leading fuel market analysis and financial support, overseeing technology implementation at JetBlue. Responsible for financial deliverables, reconciliation programs, and strategic partnerships.
About the role
- Quality Manager overseeing Quality Assurance and Quality Control functions at Probi. Driving continuous improvement for quality management in dietary supplements manufacturing.
Responsibilities
- Build a high-performing quality team.
- Mentor, coach, train, and lead quality personnel.
- Perform administrative duties such as scheduling, performance reviews, hiring, budget, etc.
- Identify and document risks and gaps applicable regulatory, GMP, GLP, ISO, and/or customer requirements.
- Keeps management informed about risks and critical non-conformities.
- Under guidance from Sr Director Global Quality, assess, recommend and establish an effective Quality Management System governing manufactured products and testing laboratories.
- Establish effective laboratory and quality processes to ensure the proper testing and release procedures are in place, including maintaining effective deviation, OOS, and CAPA systems.
- Ensure that change control, standardization of work, training, deviations, CAPA, complaints, and audits serve organizational quality objectives and priorities.
- Author, revise, and update-controlled documents, such as SOPs, forms, and charts.
- Ensure all requisite quality control activities are executed as specified in a timely manner.
- Oversee routine testing and analysis to maintain accuracy and precision.
- Ensure proper maintenance and calibration of testing equipment.
- Review and approve Master Manufacturing Records and Product Specifications.
- Oversee the review and disposition of materials to ensure they meet specifications.
- Maintain accurate and complete records of all quality and testing activities, ensuring documentation meets regulatory requirements and is readily accessible for audits.
- Preparation of clear concise audit reports that ensure mitigation of identified risks and that appropriate corrective/preventive action plans are implemented to address gaps in systems/processes and/or risks.
- Ensure effective maintenance of Certifications and Standards, including timely responses to findings and opportunities for improvements.
- Manage change controls and variations as appropriate.
- Investigate customer complaints using systematic methods and properly identify root cause and associated corrective and preventive actions.
- Keep current on changes in industry and regulatory standards for GxP requirements and advise on business impact.
- Ensure readiness of all quality activities incl. audits and inspections.
- Influence multiple stakeholders across Quality, Supply Chain and Product Development & Application departments as well as Suppliers and Customers, hence using a pro-active mindset and ability to work with stakeholders to identify and resolve findings with solutions that are fit for purpose and ensure sustained compliance performance.
Requirements
- Experience with contract manufacturing of dietary supplements.
- Prior experience with hosting regulatory inspections and development of CAPAs to address findings and preparation of formal response.
- Good knowledge of best practices in the Natural Health Products Industry.
- Prior experience testing and enumerating probiotics.
- Must be able to recognize audible and visual hazards.
- Ability to read, write, and converse in the English language.
- Must follow GMP, PPE, and company safety policies in the performance of job duties.
- Must maintain good attendance.
- Able to pass a background check.
- Proficiency with auditing process (both virtually and on site).
- Ability to influence and collaborate effectively with stakeholders at any level of the organization.
- Analytical mind, good attention to details and problem-solving skills within a structured process.
- Concise and persuasive in the description and resolution of compliance risk.
- Understanding of corporate governance processes.
- Working understanding of R&D and New Product Development practices and requirements.
- Demonstrated application of continuous improvement, change control and risk assessment.
- Fluent in English – spoken and written.
Benefits
- Medical, vision, and dental coverage after 30 days (and first day of the following month).
- Long-term and short-term disability insurance at no cost to employee.
- PTO (Paid Time Off) accrues on hire with up to 4 weeks (20 days) for new hire and increases the longer you are with the company.
- Participation in the company 401(K) and Roth plan after 6 months of employment with up to 4% employer match.
- Ten (10) paid holidays.
- 17 hours per calendar year, to go out and volunteer in your community!
- Employee Assistance Program.
- Yearly Safety shoe vouchers.
- Learning and Development Opportunities.
- Monthly birthday and anniversary celebrations.
- Team-building events throughout the year including summer and winter celebrations.
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