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, etc.
- Oversees the MOC Management of Change, deviations and corrective/preventive actions
- Manages and facilitates all compliance activities for ISO 9001 and GMP (as applicable)
- Maintain quality system documentation
- Manages and conducts plant-wide training to assure compliance with the QMS
- 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
- Coordinates all on-site 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 suppliers, service providers and external processors including evaluation of proposed new and alternate raw material suppliers
- Develops and implements new and/or improved programs to assure continual Quality improvements
- Support process improvement initiatives to minimize failures and improve right-first-time metric
- Manages the Quality department operating budget (not including salaries), 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
- Governs equipment qualification and validation protocols for new and existing equipment and analytical methods
- Participates in corporate quality initiatives and implementation at local level, as applicable
- 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
Education and Qualifications: - BS degree in Chemistry or Engineering with a MS preferred
- Internal auditor training
- Proficiency in ISO 9001 and familiarity with CGMP
- ASQ certification (CQE, CQA or CMQ/OE) preferred
- Lean and/or Six Sigma certification preferred
Experience: - Minimum of five years' experience in a CGMP environment - Food, API, Excipient or Pharmaceutical manufacturing
- 2 years' experience in a supervisory/lead role
- Hands-on experience in an analytical chemistry lab
Knowledge, Skills and Abilities: - 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. #LI-Onsite |