Quality Manager

Aurorium; Zeeland (MI); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

401(k)

Disability insurance

Flexible spending accounts

Health savings accounts

Paid time off

Paid holidays

Job summary

Aurorium, a global materials innovator, seeks a Quality Manager to lead the on-site QA/QC program, driving ISO 9001 and CGMP compliance. You’ll develop and improve the Quality Management System, lead investigations, and ensure timely product releases and regulatory alignment.

In this role you’ll manage audits, CAPA, and training across the site’s QA teams, collaborating with Regulatory Affairs and contract labs to maintain high quality standards and customer satisfaction.

Qualifications

• BS degree in Chemistry or Engineering; MS preferred.
• 7+ years’ experience in a CGMP environment—Food, API, Excipient or Pharmaceutical manufacturing.
• 3+ years’ experience in a supervisory/lead role.
• Internal auditor training.
• ASQ certification (CQE, CQA or CMQ/OE) preferred.
• Proficiency in ISO 9001 and CGMP; Lean/Six Sigma preferred.
• SAP experience and MS Office suite familiarity.

Responsibilities

• Oversee the development, implementation, review, maintenance, and management of the on-site Quality Management System.
• Approve plant procedures and changes affecting product quality; maintain SOPs and forms in the DMS.
• Collaborate with Regulatory Affairs on regulatory aspects (registration, licensing, DMFs, CEPs, validations).
• Lead Change Management, OOS, Deviation and CAPA programs; manage CGMP compliance activities.
• Coordinate audits (internal, supplier, customer) and provide timely responses and corrective actions.
• Lead investigations of customer complaints and ensure timely updates to leadership.

Skills

Leadership

Quality management

Problem solving

Time management

Training/mentoring

Autonomy

Decision making

Education

BS in Chemistry or Engineering

MS preferred

Tools

SAP

MS Office

DMS (Document Management System)

Job description

Company Overview 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. The company’s global integrated supply chain offers the customer product consistency, easy access, supply security, and reasonable turnaround on delivery. Aurorium is committed to operating at the highest levels of manufacturing consistency, quality control, and safety.

Description 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 and applicable Good Manufacturing Practices (GMP). This role ensures product quality aligns with customer expectations and regulatory requirements, while also managing investigations into internal and external quality issues.

Job Details

Role Specific 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.
• 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
• 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
• Maintains SOPs and Forms on the Aurorium DMS Document Management System
• Trends data and reports potential problems to 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

Compliance:

• 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
  

Problem Solving and Innovation:

• 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 judgement subject to overall direction or guidance
  

Knowledge, Skills, and Abilities:

• BS degree in Chemistry or Engineering with a 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
• 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.
  

If you have the energy, drive, and passion for joining the Aurorium team, we would love to hear from you. Apply today!
Aurorium offers competitive total compensation packages, including benefits such as medical, dental, vision, life, 401(k), disability insurance, flexible spending accounts, health savings accounts, paid time off, and paid holidays.
Aurorium is a global Equal Opportunity Employer. All qualified applicants will receive consideration for employment regardless of and will not be discriminated against based on gender, sexual orientation, gender identity, race, ethnicity, religion, age, veteran status, disability status, genetic information, or any other protected category.
Status Active