QA/QC Manager

Role Specific Responsibilities

• 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 conducts plant-wide training to assure compliance with the QMS
• Maintains quality system documentation
• 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
• 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
• Participates in corporate quality initiatives and implementation at local level, as applicable
• Participates in problem-solving
• Manages equipment qualification and validation protocols for new and existing equipment and analytical methods
• Performs other duties as assigned

Problem Solving and Innovation

• 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

Education and Qualifications

• 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

Experience

• 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
• Leverage Lean and/or Six Sigma certification preferred

Knowledge, Skills and Abilities

• Minimum of five years’ experience in a CGMP environment – Food, API, Excipient or Pharmaceutical manufacturing
• Two years’ experience in a supervisory/lead role
• Hands-on experience in an analytical chemistry lab