Quality Manager

COMPANY INFORMATION

Probi USA is a growing manufacturing company in Lafayette, CO. Probi USA is a leading producer of probiotics and a veteran contract manufacturer in the nutritional supplement marketplace. We produce a wide variety of superior products for many of the world’s most recognized private labels and brands. At Probi, our diverse group of employees shares a common goal to produce and market the best nutraceutical products available. 

We are currently seeking candidates for our Quality Manager position to work in our manufacturing plant in Lafayette, CO. This full-time position(s) reports to the Global Quality Director 
Schedule is Monday through Friday, 6:00 AM to 2:30 PM, 

Are you looking for a stable company? Do you want to work and have fun while doing so? Well...Probi USA is that company! Come join our great company!

POSITION SUMMARY

The Quality Manager leads the Quality Assurance and Quality Control function in Colorado and reports to the Sr. Director of Global Quality. Under the guidance of the Sr Director Global Quality, the Quality Manager is responsible for assessing the current and establishing an improved and effective Quality Management System to ensure the system meets regulatory and industry standards.  They utilize an extensive set of quality skills to help drive continuous improvement, ensure the quality attributes of products are met, and develop highly skilled teams. They monitor quality metrics and report these up to senior management. They are the primary point of contact for second- and third-party audits and inspections, testing review and disposition, and customer complaints and investigations. This role forms partnerships with plant leadership to drive the success of the organization.

The Quality Manager oversees and manages the quality teams in Lafeyette, which includes Quality Assurance and the microbiological laboratory.

KEY JOB DUTIES
• 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.

COMPANY 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.

WORK EXPERIENCE AND EDUCATION REQUIREMENTS
• Degree (BSc or MSc) or equivalent experience in a relevant technical field.
• Minimum of 3 years working with cGMP and GLP regulatory, testing, and manufacturing requirements for ingredients, food, and dietary supplements.
• Minimum 3 years of demonstrated experience in microbiology laboratories utilizing plating and enrichment techniques.
• Demonstrated knowledge and experience in performing ISO 22,000 audits. Awareness of ISO 17025 Lab Standards and ISO 9001 Quality Systems standards.
• Demonstrated knowledge conducting hazard analysis and establishing risk-based control points. 

BENEFITS FOR US EMPLOYEES

• Medical, vision, and dental coverage after 30 days (and first day of the following month) with approximately 85% being paid by employer. Three (3) plans to choose from.  
• 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.  
  
• Nine (9) paid holidays.
• 17 hour per calendar year to volunteer in the community. 
• $100 Wellness dollars per year. 
• Free daily uniforms, safety shoe vouchers. 
• Employee Referral Bonus
• Tuition Reimbursement 
• Monthly birthday and anniversary celebrations.
• Team-building events throughout the year including summer and winter celebrations.
  

As part of our interview process, we have partnered with Alva Labs to help us place the right people in the right role as we believe in the use of science-based and fair assessment methods. Therefore, as part of our recruitment process, the Alva Labs assessments will help us increase our hiring success by identifying the candidates that are most likely to thrive and be successful in the role. Please be on the lookout for an email from Alva Labs with the link to take our online psychometric assessment. The psychometric assessments will help determine if a candidate has the right Logic traits and Personality Traits for the position. Please complete the assessment to be considered further in our hiring process. 

Probi USA is an Equal Employment Opportunity (EEO)/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, age, disability, marital status, veteran status or any other protected factor. 

Probi shall not use child labor. All work performed at Probi is based on recognized employment relationship established through national law and practice.  

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Salary : $105,000 - $130,000