Quality Assurance Specialist

Quality Assurance Specialist

Holyoke, Massachusetts, United States

The Role

The purpose of this position is to ensure the successful quality and compliance management operations at all GTI sites. This position is to ensure through process performance audits that all raw ingredients, raw materials, packaging, and finished products comply with all applicable regulations and meet or exceed the customer's expectations and to act when predefined standards are not met. This position will also help manage product quality tracking systems, FDA standards, internal and external audits, etc. The goal for this role is to ensure compliance with all Green Thumb corporate operating procedures, as well as applicable federal, state, county, and municipal laws, regulations, ordinances, and regulations.

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.
• Assist in site HACCP Plan and quality system reviews and provide recommendations for improvements.
• Assist the Quality Manager in the implementation of HACCP, allergen, sanitization, and other programs of the Quality Management System.
• 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.
• Strong knowledge of compliance terminology, laws, rules, and regulations of industry and laws as issued by the state regulatory body.
• 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.
• Assist 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.
• Perform assigned Quality Inspections.
• Perform improvement projects as identified.
• Collect quality data and report metrics to management.
• Monitors compliance to established Good Manufacturing Practice (GMP) guidance.
• Expected to adhere to safe work practices, follow GMP and HACCP guidelines, maintain sanitary conditions and ensure that product quality is maintained. Report to management any conditions or practices that may adversely affect product safety, product quality or personnel safety.
• Maintain a positive work atmosphere by acting and communicating in a manner so that you get along with customers, clients, co-workers and management.
• Perform assigned Quality Inspections.
• May make decisions and perform the job responsibilities of the Quality & Compliance Manager in their absence.
• Performs other duties as assigned.

Working Conditions

• Work involves daily exposure to allergens (such as cannabis, tree nuts, and coconut oil).

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
• Must be able to work variable day shifts dependent on business need
• 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 foodpharmaceutical 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
• Exceptional computer skills in Microsoft Office Suite (Access, Excel, Outlook, PowerPoint, Publisher, Word)
• Strong detail-oriented and resourceful mindset

Additional Requirements

• Must pass all required background checks.
• Must be and remain compliant with all legal or company regulations for working in the cannabis industry.
• Must possess valid driver's license.
• Must be a minimum of 21 years of age.
• Must be approved by state badging agency to work in cannabis industry.

The pay range is competitive and based on experience, qualifications, and/or location of the role. Positions may be eligible for a discretionary annual incentive program driven by organization and individual performance.

Green Thumb Pay Range

$60,000 - $80,000 USD