Quality Manager

About the Role

Aurorium is the materials innovation partner that helps global manufacturers harness the power of possibility, enhancing quality of life, supporting health and wellness, and enabling value-added solutions. Key industries served include healthcare, personal & home care, mobility, infrastructure, and specialty paper & packaging. As a Responsible Care® company, Aurorium adheres to the highest regulatory standards across all manufacturing facilities.

Responsibilities

• Oversee the development, implementation, review, maintenance, and management of the on-site Quality Management System.
• Hold decision-making authority at the site level regarding material and product quality.
• Approve all plant procedures and any changes that may affect product quality.
• Collaborate with Regulatory Affairs on all regulatory aspects of the product, including registration, licensing, DMFs, CEPs, analytical method validation, and process validation.
• Oversee the MOC (Management of Change), OOS (Out of Specification), Deviation, and CAPA (Corrective and Preventive Action) programs.
• Manage and facilitate all compliance activities for ISO, CGMP, etc.
• Maintain SOPs and forms on the Aurorium Document Management System (DMS).
• Manage and conduct plant-wide CGMP training to ensure compliance with all regulations.
• Ensure efficient and safe operations of the lab and coordinate daily workload to ensure timely testing and releases.
• Manage and coordinate the flow of documentation from Production to Quality to ensure timely review of documents.
• Audit site operations against existing SOPs and methods for conformance (e.g., technical quality of work, methods, and instrumentation). Write audit reports and recommend corrective action.
• Trend data and report potential problems to the site leadership team.
• Oversee the Stability Program and Annual Product Review for products supplied by the site.
• Coordinate all on-site quality-based regulatory and customer audits and provide written responses as necessary in a timely fashion.
• Lead the investigation of all customer complaints/dissatisfactions and provide timely updates and reports.
• Audit contract laboratories and processors, including the evaluation of proposed new and alternate raw material suppliers.
• Develop and implement new and/or improved programs to ensure continual quality improvements.
• Manage the Quality department budget (excluding salaried personnel) and QA/QC personnel.
• Manage Quality Agreements with both suppliers and customers, acting as the primary point of contact for customer quality-related inquiries.
• Comply with company Health, Safety, and Environmental policies, procedures, and arrangements.
• Report all Health, Safety, and Environmental accidents, incidents, and near misses promptly.
• Perform other duties as assigned.

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.
• 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.

Skills

• Embodies Aurorium’s core values: credible, outcome-oriented, driven, and empowered accountability.
• Active participation in continuous improvement activities.
• Participates in problem-solving.
• Takes responsibility and ownership for learning and development.
• Assists in the training, mentoring, and assessment of other team members.

Benefits

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