Quality Assurance Specialist

Responsibilities

• Supports the Quality Department and ensure all employees understand and follow all standard operating procedures (SOPs).
• Define, implement, and improve the Quality Management System with guidance from the site Quality Manager including development of process and product testing to ensure quality standards are met and oversee determination of finished product disposition.
• Implement, maintain, and audit quality control practices and operations to ensure the safety, quality, and compliance of cannabis.
• Aid in the management of the HACCP Plan and quality system reviews and provide recommendations for improvements.
• Manage and perform document controller responsibilities through the Electronic Quality Management System.
• Oversee completeness and good documentation practices of in-process batch records.
• Partner with management to lead quality initiatives that develop and maintain a high performing, scalable, and compliant quality system.
• Perform or oversee routine audits of compliance processes to assure accuracy and thoroughness of completion.
• Participate in and facilitate state regulatory compliance inspections, investigate, and resolve compliance concerns, issues, or violations.
• Conducts weekly compliance risk assessments and identifies potential areas of vulnerability and risk, develops/implements corrective action plans for resolution of issues, and provides general guidance on how to avoid recurrence of same or similar issues in the future.
• Annual inventory planning and summary generation for regulatory (state regulatory body) submission.
• Label/packaging review and approval adhering to regulatory requirements.
• Works with Quality and Compliance Manager to identify all legal and regulatory requirements and legislative updates applicable to all the site’s business lines and keeps up to date in changes of the regulatory requirements.
• Provides guidance on various departments regarding compliance issues and implementation of new compliance requirements with respect to regulatory and contractual requirements.
• Conduct research on compliance topics, including but not limited to privacy, federal regulations, state laws and related publications for known risk areas.
• Ensures that compliance issues/concerns within the organization are being appropriately evaluated, investigated, and resolved.
• Work with department leaders to troubleshoot any deficiencies that surface, to ensure issues get rectified quickly with high standard.
• Analyze facility trends to assess potential areas of continued non-compliance.
• Routinely reviews monthly corporate QA/QC documentation and assures that all areas of concern are addressed appropriately according to corporate policy and regulatory standards.
• Affixes to production personnel in the investigation of root causes and corrective action of internal rejects, corrective/preventive action, preventive control points, and customer complaints.
• Continually study the existing quality system and make recommendations for improvements.
• Performs assigned Quality Inspections.
• May make decisions and perform the job responsibilities of the Quality & Compliance Manager in their absence.
• Performs other duties as assigned.

Qualifications

• Associate degree in Food Science, Biology, Chemistry, or a related field required, Bachelor’s Degree in Food Science, Biology, Chemistry, or a related field preferred.
• 3+ years of regulatory compliance management including interfacing with regulators and inspectors.
• 5+ years work experience with a proven track record of building and developing QA/QC processes and systems.
• Must have the knowledge and skills required to work in a fast paced and challenging environment.
• Knowledge of the GMP, HACCP and Environmental sanitation programs.
• Experience with SQF, ISO, GMP, ASQ, HACCP, PCQI or similar certification experience preferred.
• QMS auditor or similar certification preferred.
• Possess a strong knowledge of sanitary design, specification, and implementation of food\pharmaceutical processing systems.
• Ability to deliver specific organizational goals and effectively develop, grow, and manage a diverse multisite team to achieve objectives.
• Track record of engaging teams and creating a collaborative culture.
• Excellent verbal, written and presentation skills.
• Strong computer skills in Microsoft® Office Suite (Access, Excel, Outlook, PowerPoint, Publisher, Word).
• Strong detail-oriented and resourceful mindset.