Quality Engineer (Supplier Management)

Company: Disability Solutions
Location: Raleigh
Posted on: September 1, 2024

Job Description:

Based in the Raleigh, NC Corporate office - Hybrid Step into the future with us at Merz Therapeutics, where our family roots meet a bold new vision. Together, we're embarking on a transformative journey, blending time-honored traditions with exciting new products. As a private, family-owned company, we have the liberty and support to make decisions for ourselves, our customers and the patients we serve. We pride ourselves on building an inclusive culture where there is room to celebrate individual growth with the ability to contribute to a common good as a collaborative team. Our mission is grounded in a long-term view of making a difference for the common good, while growing together as a family. If you're looking to immerse yourself in a passionate team rooted in community, connection and camaraderie, then we're looking for YOU! #IAmMerz Are you ready to galvanize a team around a culture of care, putting patients first to spark change? The Quality Engineer will provide assistance with all quality system functions related to Batch Release operations, Supplier Management and Deviation management. Core activities for this role involving Batch Release operations such as batch record review, deviations, investigations, change controls, CAPAs, and recall management relating to drug products and components. Core activities for this role involving Supplier Management program will include conducting supplier audits, supplier re-evaluations, supplier ratings, Writing audit reports, supplier corrective action management, and the facilitation and implementation of process improvement projects. Core activities for this role involving deviation management will be tracking of deviations, corrective action and preventive action plan review, CAPA effectiveness checks, and CAPA closures.Essential Duties & ResponsibilitiesLocal Quality Assurance

• Contributing to the operations of the Quality Management System requirements for Merz therapeutics U.S. and Canada within Global therapeutics Quality Management System
• Contributing to the Supplier Management program through supplier qualification activities, supplier audits as lead auditor or co-auditor, writing supplier evaluation and audit reports, maintaining contracts, monitoring performance and maintaining the audit schedule
• Issuing Supplier Corrective Action requests (SCAR) activity implementation, reporting, and close out
• Creating, revising, maintaining Quality Assurance Agreements with suppliers and partners
• Working with regulatory officials during local quality inspections and supporting all Merz sites globally with any requests for information from an authority inspection
• Participating in internal corporate audits and authority inspections
• Supporting the monitoring, tracking and investigating of deviations as well as Corrective Action and Preventive Action (CAPA) implementation and closeoutBatch Release Operations
  • Manage batch release operations activities, including but not limited to master and executed batch record review, deviations, investigations, change controls, CAPAs, and analytical data review.
  • Reviewing batch records, product specifications, Certificates of Analysis and all other supporting documentation related to the release of product.
  • Reviewing incoming inspection on parts and components and providing release decision.
  • Managing Quality events such as deviations and investigations, CAPAs, and change controls related to Contract Manufacturing Organizations (CMO) manufacturing areas.
  • Facilitate and resolve quality issues with CMOs and internal stakeholders; ensure that products meet all required quality standards and specifications.
  • Recall Management. Support for recall strategy, execution, reporting. Also, for scheduling and carrying out recall simulations/mock recall activities.Global Quality Assurance Collaboration
    • Responsible for maintaining compliance with Global therapeutics Quality Management System
    • Participating in internal auditing system by global quality assurance
    • Liaison to Global Quality functions, ensuring local compliance to global requirements and ensuring consideration for local requirements within global system
    • Participate in cross-functional project teams, when appropriateOther duties as assigned
      • Supporting local leadership in any safety/quality objectives as applicable
      • Contributing to quality improvement activities
      • Staying up to date on all SOP reading/training requirements
      • Notifying manager of regulatory compliance questions and issuesJob Related Qualifications / SkillsEducation- Bachelor's degree in a Physical Science or Engineering, or equivalent experience requiredProfessional experience
        • Strong knowledge and experience with global GMP regulations, principles and guidelines, current industry standards, best practices, and methodologies required.
        • Experience performing formal drug product and/or medical device release for market distribution required.
        • Minimum 5 years Quality Assurance Pharmaceutical, Medical Device and/or other regulated industry or similar experience preferred.
        • ASQ Certification as a Quality Engineer preferred.
        • ASQ Certification as a Quality Auditor preferred.
        • Experience working in and with different people and organizational cultures, supporting people with diverse backgrounds, attitudes and cultural differences preferred.Knowledge, skills and abilities (incl. languages)
          • Strong comprehension of current pharmaceutical regulations and guidances (FDA/Health Canada/EU/ICH) and regulatory expectations for Drug Substance required.
          • Understanding of quality assurance and ability to communicate with Regulatory and Quality personnel required.
          • Must be proficient in Microsoft Office applications including Word, Excel and PowerPoint.Knowledge of methods-Working knowledge of GMP, US Food and Drug Regulations, including biologics, and ISO 9001 required.Personal skills
            • Organizational skills and attention to detail to effectively prioritize and manage complex projects within established timelines required.
            • Strong interpersonal and team collaboration skills preferred.
            • Excellent verbal and written communication skills. Ability to clearly articulate quality concepts preferred.
            • Strong multi-tasking, time management, and organizational skills preferred.Don't meet every single requirement? Studies have shown that women and people of color are less likely to apply to jobs unless they meet every single qualification. At Merz Therapeutics we are dedicated to building a diverse, inclusive, and authentic workplace, so if you're excited about this role but your past experience doesn't align perfectly with every qualification in the job description, we encourage you to apply anyways. You may be just the right candidate for this or other roles. Recruitment Note: Merz Therapeutics only sends emails from verified "merz.com" addresses and never asks for sensitive, personal information or money. If you have any doubts about the authenticity of any type of communication from, or on behalf of Merz Therapeutics, please contact Therapeutics.HR@merz.com

Keywords: Disability Solutions, Raleigh , Quality Engineer (Supplier Management), Engineering , Raleigh, North Carolina