What are the responsibilities and job description for the Quality Assurance Specialist II position at AMERILAB TECHNOLOGIES, INC?
HBI Amerilab Technologies is a growing and leading US manufacturer in the development, manufacturing, and packaging of effervescent tablets, and effervescent and non-effervescent powders in stick packs and sachets, and we are currently seeking a skilled and experienced Quality Assurance Specialist II to join our team.
Responsible for ensuring operational adherence and compliance to Quality Management System (QMS) requirements. This role will be expected to provide input on, and contribute to, and implementation of Quality System improvement strategies and approaches. Key areas of focus include support of the organization’s quality management system, providing support for third party quality certifications (e.g. ASQ 455-2, GFSI/SQF, Kosher, Halal, GFCO, etc.), support of internal/external audits, document control, and regulatory compliance. Provides support to Quality Control, Supply Chain and Production departments.
Your responsibilities will include:
- Support for CAPA system administration, tracking individual CAPAs, and, as necessary, performing work on individual CAPAs.
- Participate in the Food Safety team
- Review and offer direction on the HACCP plans including meeting with Food Safety team and making changes as needed.
- Perform investigation/analysis of returned/complaint materials.
- Perform Manufacturing investigations according to company and client requirements.
- Review Standard Operating Procedures (SOPs) in relation to manufacturing and engineering functions. Make recommendations for changes as necessary.
- Maintain returned goods program and approve product destruction notices.
- Knowledge of ID, traceability, containment requirements, Material Disposition process.
- Participate in Quality Management System initiatives and continuous improvement activities.
- Assist in development of training on multiple quality initiatives and requirements including Good Manufacturing Practices (GMP), Gluten Free, new hire orientation, etc.
- Support Qualification activities and maintenance of the Approved Supplier List. Support management of Supplier/vendor Corrective Actions (SCAR).
- Support site customer-requested auditing activities (Customer and Regulatory Agencies).
- Support Preventive Maintenance, Calibration & Metrology.
- Support generation of Quality Plans for the QMS and Organizational Objectives projects.
- Measure and report quality system metrics providing statistical data/trending analysis, etc.
- Provide support for generation, tracking/trending & reporting of quality system metrics, as required.
- Ensure compliance of all site personnel to QMS requirements.
- Ensure adherence to training requirements regarding Quality Management System elements, controls, processes, and procedures.
- Perform Internal Audits and walkthroughs of the manufacturing facility, reporting findings to responsible parties.
Other Duties and Responsibilities:
Understand and adhere to Good Manufacturing Practices.
Safety Protocol:
- Stop any observed unsafe acts and obey facility safety rules and procedures.
- Correct or report any observed safety hazards.
- Support safety policies and programs.
This list of duties and responsibilities is not all-inclusive and may be expanded to include other duties and responsibilities, as deemed necessary from time to time.
