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Aurorium · 8 hours ago

Quality Manager

Berkeley Heights, NJ

Full-time

Onsite

Senior Level

7+ years exp

Aurorium is the materials innovation partner that helps global manufacturers harness the power of possibility to make the world a better place. The Quality Manager is accountable for developing and implementing a robust quality management system, ensuring product quality aligns with customer expectations and regulatory requirements, while managing investigations into quality issues.

ChemicalIndustrialManufacturing

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 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

Performs other duties as assigned

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

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

Qualification

ISO 9001CGMPQuality Management SystemASQ certificationLean/Six Sigma certificationAnalytical chemistry labComputer literateSupervisory experienceTime managementProblem solving