QA​/QC Manager

Vacancy NameQA/QC Manager Vacancy No

VN
639

Department Quality Location Pasadena Employment  Type Full-Time 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 ISO 9001. 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, 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 QMSEnsures 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…