Probi AB

Quality Manager

Probi AB

full-time

Posted on:

Location Type: Office

Location: Lafayette • Colorado • United States

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Salary

💰 $105,000 - $130,000 per year

About the role

  • 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.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
Quality Management SystemGMPGLPISOCAPASOPsauditing processrisk assessmenttesting and analysisprobiotics testing
Soft Skills
mentoringcoachingleadershipanalytical thinkingproblem-solvingattention to detailinfluencingcollaborationcommunicationpro-active mindset