Quality Manager

Aurorium is the materials innovation partner that helps global manufacturers harness the power of possibility, making the world a better place. Their specialty ingredients and high-performance materials enhance quality of life, support health and wellness, and enable customers to deliver value-added solutions. Key industries served include healthcare, personal & home care, mobility, infrastructure, and specialty paper & packaging. A Responsible Care® company, Aurorium follows the highest regulatory standards across all manufacturing facilities.

About the role

The Quality Manager is the site's primary leader for all Quality Assurance (QA) and Quality Control (QC) activities. They are accountable for developing, implementing, and continuously improving a robust quality management system that adheres to standards such as ISO 9001, SQF, and applicable Good Manufacturing Practices (GMP). This role ensures product quality aligns with customer expectations and regulatory requirements while managing investigations into internal and external quality issues.

Responsibilities

• Has responsibility and authority to oversee the development, implementation, review, maintenance, and management of the on-site Quality Management System
• Holds decision-making authority at site level regarding material and product quality
• Approves all plant procedures and any changes that may affect product quality
• Collaborates with Regulatory Affairs on all regulatory aspects of the product including registration, licensing, DMFs, CEPs, analytical method validation, process validation, etc.
• Maintains GFSI Global Food Safety Certification (SQF)
• Oversees the MOC (Management of Change), OOS (Out of Specification), Deviation, and CAPA (Corrective and Preventive Action) programs
• Manages and facilitates all compliance activities for ISO, CGMP, etc.
• Maintains SOPs and forms on the Aurorium DMS (Document Management System)
• Manages and conducts plant-wide CGMP training to assure compliance with all regulations
• Ensures efficient and safe operations of the lab and coordinates daily workload to ensure testing and releases are conducted in a timely manner
• Manages/coordinates flow of documentation from Production to Quality to ensure timely review of documents
• Audits site operations against existing SOPs and methods for conformance (e.g., technical quality of work, methods, and instrumentation). Writes audit reports and recommends corrective action
• Trends data and reports potential problems to the site leadership team
• Oversees Stability Program and Annual Product Review for the products supplied by the site
• Coordinates all on-site quality-based regulatory and customer audits and provides written responses as necessary in a timely fashion
• Leads the investigation of all customer complaints/dissatisfactions and provides timely updates and reports as required
• Responsible for auditing contract laboratories and processors, including evaluation of proposed new and alternate raw material suppliers
• Develops and implements new and/or improved programs to assure continual quality improvements
• Manages the Quality department budget (not including salaried), through direct involvement and management of QA and QC personnel
• Manages Quality Agreements with both suppliers and customers, and acts as the primary point of contact for customer quality-related inquiries
• Performs other duties as assigned
• Complies with company Health, Safety, and Environmental policies, procedures, and arrangements
• Reports all Health, Safety, and Environmental accidents, incidents, and near misses promptly
• Acts in a safe and responsible manner at all times
• Active participation in continuous improvement activities
• Participates in problem-solving
• Takes responsibility and ownership for own learning and development in the spirit of continuous improvement of both self and the business
• Assists in the training, mentoring, and assessment of other team members
• Exercises autonomy and judgment subject to overall direction or guidance

Requirements

• BS degree in Chemistry or Engineering (MS preferred)
• Internal auditor training
• Proficiency in ISO 9001 and CGMP
• ASQ certification (CQE, CQA, or CMQ/OE) preferred
• Lean and/or Six Sigma certification preferred
• 7+ years’ experience in a CGMP environment – Food, API, Excipient, or Pharmaceutical manufacturing
• 3+ years’ experience in a supervisory/lead role
• Hands-on experience in an analytical chemistry lab

Skills

• Ability to solve practical problems and deal with a variety of changing situations
• Strong time management and prioritization skills
• Computer literate: MS Word, Excel, Access, PowerPoint; SAP experience preferred
• Technical/Professional Knowledge and Skills analysis
• Embodies the core values of Aurorium:
  • Credible: keeps their word and honors their commitments, acts with integrity, and holds themselves accountable to their decisions and actions
  • Outcome-oriented: adheres to an unparalleled standard of excellence in everything they do, to deliver results with real impact
  • Driven: passionate about delivering authentic, world-class experiences that engage customers and inspire greatness
  • Empowered accountability: empowered to achieve common goals and accountable for delivering performances and results that exceed standard

Benefits

• Medical, dental, and vision insurance
• Life and disability insurance
• 401(k) retirement plan
• Flexible spending accounts
• Health savings accounts
• Paid time off
• Paid holidays