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Quality Assurance Manager

Company: Elemental Enzymes
Location: Saint Louis
Posted on: March 20, 2023

Job Description:

About Elemental EnzymesElemental Enzymes was founded upon the simple belief that we must do everything we can to improve agricultural performance in a way that not only enables plants to flourish but enriches and renews the planet with eco-friendly and sustainable agricultural solutions. From products that enable effective enzyme, peptide and protein inputs to foliar treatments that hold the promise to renew entire industries, our focus to make a positive difference in the world through people - like you and me. Success is a byproduct of responsible production. That's why Elemental Enzymes works to bring cross-disciplinary scientists and processes together to create novel solutions to practical problems with a shared goal of helping both the plant and the planet.*Job Description*The Quality Assurance (QA) Manager will provide Quality oversite to ensure compliance with applicable quality objectives and regulatory requirements with the Quality department leading the Quality Assurance function. The QA Manager will be responsible for developing the QA function while leading day to day operations within the QA function. This is a very exciting opportunity to join a rapidly growing Biotechnology company and have influence on creating strategic, tactical, and operational plans that align with the company's strategic growth aspirations.The QA Manager will have responsibilities in the following areas:*Product & Process:*

  • Provide quality oversight and support for new product introductions as primary quality point of contact
    • Review executed production batch records, environmental monitoring data (as required), analytical data, and associated documentation, including any trends, deviations, and investigation reports related to lot release of product disposition ensuring the compliance of the whole product specifications
      • Perform Product Disposition and Lot Closure using enterprise resource planning (ERP) programs
      • Track and respond to quality-related customer questions and/or complaints.
      • Reviews manufacturing, environmental monitoring, and quality control data for in process and finished products
      • Ensure process control measures are in place and followed in product manufacturing.
      • Identifies critical, non-critical, user calibrated, and non-calibrated instruments per the process requirements (in conjunction with process development) and manages the calibration of the instrument to ensure compliance
      • Works with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications
      • Approve process and equipment qualifications and validations and ensure proper handoff of product and process development packages from process development team to manufacturing
      • Manages and lead the product and process change management ensuring product quality is not impacted with any product/process proposed changes
      • Provide QA oversight and review of deviations tied to lots. Ensure deviations are properly initiated, investigated, and resolved in accordance with established disposition timelines
      • Provide QA oversight and approval of CAPAs. Ensures that associated CAPAs are initiated and resolved
      • Manage and monitor CAPAs for successful completion and successful implementation
      • Monitor all proposed changes of CAPAs through the Management of Change (MOC) process
      • As assigned, manage, and provide QA oversight for other processes, including training
      • Support Lean Manufacturing principles to ensure process-in-controlQuality Systems:
        • Leads the development and review of Standard Operating Procedures (SOPs) to ensure quality objectives are met within the organization
        • Write, review, and approve Operating Procedures, Manufacturing documents, Technical Transfer Protocols, and other controlled documents under a Quality Managed System (QMS).
        • Interact with key stakeholders such as R&D, Process Development, Manufacturing
        • Regulatory Affairs, and Commercial to ensure that Products are manufactured in accordance with established procedures and appropriate regulations
        • Manage the tracking of deviations, CAPAs, and audits
        • Manage all product and process change proposals and executed changes through a Management of Change (MOC) process
        • Maintains routine programs and processes to ensure high quality products and compliance with current best practices, such as cGMP, and with ISO9001 management requirements.
        • Lead and participate in internal/external inspection and audits
        • Maintain metrics related to product disposition in support of the Management Review.
        • Generate and report data for managementLeadership & Management:
          • The QA Manager will not have direct reports upon hire; however, the QA Manager will responsible for identifying the QA function needs, and built against the needs, including the personnel necessary to have a world class Quality Assurance team
            • Attracts, develops, and retains a high performing team to meet the current and evolving needs of the business through effective selection, training, and development, coaching and mentoring and performance management
            • Lead departments in development and successful completion of individual and departmental goalsKnowledge, Experience, and Skills:
              • Expert level knowledge of Quality Systems, specifically ISO 9001, is required
              • Good working knowledge of Environmental and Occupational Health and Safety systems, such as ISO 14001 and 45001, is required
              • Good working knowledge of Good Manufacturing Practices standards applicable to biotechnology is preferred
              • Expert level knowledge on performing and leading audits
              • Must be able to work as an individual contributor until the QA function is built
              • Ability to work on complex, non-routine assignments where analysis of the situation or data requires a review of identifiable factors
              • Ability to effectively participate in cross-functional teams
              • Ability to coordinate the planning, organization, and implementation of project deliverables within specified objectives
                • An accountable team player who is detail and quality oriented with solid understanding of quality assurance principles, systems, and procedures
                • Excellent attitude with strong verbal, written, and interpersonal communication skills
                • Self-starter, able to work independentlyBasic Qualifications/Requirements:
                  • Bachelor's degree in the biological sciences, biological/chemical engineering or related field and 10+ years of progressive experience in a pharmaceutical, biotech, or biologics operation, or equivalent education/work experience
                  • Expert knowledge of ISO 9001 Quality Management Systems is required
                  • Working knowledge of ISO 14001/45001 EHS and OHS Systems is required
                  • Good working knowledge of ERP Systems, i.e., SAP, is required
                  • Prior experience in pharmaceutical and regulated biotech and or chemical industry is required
                  • Good working knowledge of Good Manufacturing Practices, based on FDA 21 CFR, is highly preferred
                  • Demonstrates knowledge of six sigma, LEAN, and root cause analysis tools used for identifying and correcting deviations
                  • Demonstrates audit and investigation skills, and report writing skills
                  • Ability to interpret and apply procedural and regulatory guidance in potentially ambiguous
                  • Ability to understand risk and provide phase-appropriate decisions
                  • Ability to effectively negotiate and build collaboration amongst individuals
                  • Candidates must have good interpersonal skills, strong written communication skills and strong analytical skills
                  • Comfortable in a fast-paced small company environment and operate with minimal direction
                  • Ability to adjust workload based upon rapidly changing priorities
                  • Role is onsite with potential flex schedule depending on the candidate.Job LocationSt. Louis, MO, United StatesPosition TypeFull-Time/Regular/ Exempt/ SalaryApplyPlease fill out the application and attach a cover letter and CV/R--sum--. References required upon request.Job Type: Full-time

Keywords: Elemental Enzymes, St. Louis , Quality Assurance Manager, Executive , Saint Louis, Missouri

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