Cansortium Inc is a vertically integrated cultivator, processor, formulator, and retailer of Premium Cannabis Products currently operating in Florida, Pennsylvania and Texas as Fluent Cannabis. Our purpose is to compassionately provide patients access to the highest level of medical cannabis in an unrivaled, professional healthcare environment with outstanding customer service. Patient care always comes first at Fluent and our standards, practices, and performance is unmatched.
We are looking for leaders who want to work alongside great talent and create a positive work experience for their team. We are focused on continuous improvements, which creates development opportunities, engaged feedback, and increased contributions towards our goals as a leader in the medical cannabis industry.
Find out more at www.getfluent.com. Follow us on LinkedIn.
ROLE SUMMARY:
The Quality Assurance Manager will guide and provide oversight in the development, implementation, and enforcement of quality standards, policies, procedures, and programs to ensure safe and compliant conditions for the extraction, manufacture, and packaging of cannabis and cannabis containing products. This role will oversee and manage the day-to-day operations as they relate to the quality management system oversight of all areas under cGMP standards. The Quality Assurance Manager is responsible for assuring compliance with 3rd party requirements (including state and/or federal) and potential audits. The ideal candidate will excel as a team leader within a manufacturing environment, where attention to detail is important, collaboration is critical, the work is deadline driven, and highly regulated.
KEY RESPONSIBILITIES:
- Ensure Quality Assurance, Quality Control, internal and regulatory compliance and audits, and GAP identification.
- Adherence to the Standard Operating Procedures (SOPs) for the Good Production Practices (GPP) of the Licensed operations, the drafting of all SOPs and their work instructions, and training staff in these for correct implementation in operations and regulatory compliance.
- Maintaining performance standards, procedures, and audit controls to meet state requirements and standard operating procedure and work instructions development and approval.
- Maintenance of GPPs as they pertain to premises, equipment, and sanitation, complying with quality assurance policies.
- Management of an effective sanitation program to ensure production, packaging, labeling and storage activities involving cannabis are conducted under sanitary conditions.
- Manage the Quality Assurance department and personnel.
- Assist all plant quality related activities, providing support as the primary facility resource for problem identification, resolution, loss reporting and continuous improvement.
- Perform statistical analysis of data to ensure that all policies, trends, and specifications are maintained throughout stability studies.
- Responsible for all facility quality related Key Performance Indicator (KPI) reporting and performance. Establish and implement Process Indicators (PI) and metrics (process capability, control charts, measurement quality) for monitoring system effectiveness.
- Ensure all cannabis and cannabis containing products produced at the facility are properly tested in accordance with company procedures and guidelines, at appropriate frequencies, and meet specifications prior to release.
- Ensure testing data is appropriately documented and maintained.
- Assist in aligning the company all state, federal and 3rd party requirements.
- Collaboration with Security Supervisors to ensure proper implementation of Building Security Measures pertaining to the operations and the handling of product.
- Conduct internal audits to ensure readiness and host audits from external auditors and regulatory personnel.
- Maintain finished product specifications and labels (nutritional, labeling, shelf life, etc.) and ensure compliance.
- Support applicable ISO 17025 (Testing and Calibration) directives. Ensure all equipment used is calibrated appropriately and anticipate maintenance when needed.
- Coordinate and generate End-To-End Annual Product Quality Review reports.
- Oversee recalls, complaint management, approval of product quality prior to approval for sale; product return management; sample retention; and reporting adverse reactions.
- Identify and implement process improvements to increase the efficiency, effectiveness, and quality, oversee new equipment implementation or modification and validation.
- Work with production team performing in product manufacturing processes validation for regulatory submissions, and preparation for regulatory inspections and commercial production.
- Staff training to ensure regulatory compliance with all aspects of the high standards of quality control.
- Assist with other production tasks as needed.
QUALIFICATIONS:
- Bachelor of Science degree or related field.
- Minimum four years of experience in a Quality Management/ Quality Control, supporting Pharmaceutical, Manufacturing or other regulated industry.
- GMP knowledge with a focus in operational excellence in GMPs, recalls, electronic and hard copy records in an operational environment.
- Experience in identifying GMP gaps with experience in writing SOPS, work instructions, identifying GAPs, and with regulatory compliance and internal and external audits experience.
- Exposure to and working knowledge of manual and computer-generated batch records and record keeping complying with state regulations.
- Experience in an ISO: 9001, ISO: 13485 or ISO: 17025 environments is an asset.
SKILLS / INTERESTS:
- Strong relationship and interpersonal skills especially with diverse groups of people
- Entrepreneurial attitude with an interest in learning, understanding, growing, and improving the business
- A champion of change with courage of convictions
- Detail-oriented, well-organized, focused, and driven
- Excellent communication skills, both written and verbal
- Strong integrity and the ability to influence others
REQUIRED EDUCATION and EXPERIENCE:
Bachelor of Science degree or related field.
Minimum four years of experience in a Quality Management/ Quality Control, supporting Pharmaceutical, Manufacturing or other regulated industry.
ADDITIONAL REQUIREMENTS:
Per state law, must be at least 21 years of age.
Must successfully complete a comprehensive background check.
Must pass a drug screening
SUPERVISORY RESPONSIBILITIES:
This position has supervisory responsibility to the Quality Assurance Team.
WORK ENVIRONMENT:
This position operates in cultivation and manufacturing environments. This role routinely uses cultivation processing equipment and standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
PHYSICAL DEMANDS:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to be able to speak and hear. Employee needs to be able to sit at a workstation for extended periods; use hand(s) to handle or feel objects, tools, or controls; reach with hands and arms and ability to work on desktop or laptop computer for extended periods of time reading, reviewing/analyzing information, and providing recommendations, summaries and/or reports in written format. Must be able to effectively communicate with others verbally and in writing. Employee may be required to occasionally lift and/or move moderate amounts of weight, typically less than 20 pounds. Regular and predictable attendance is essential.
POSITION TYPE / EXPECTED HOURS OF WORK:
This position will be required to work the evening shift and weekends and regularly requires long hours.
TRAVEL:
Travel is not required although some out-of-the-area travel may be requested on an as needed basis.
OTHER DUTIES:
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
AAP/EEO Statement:
Fluent is an equal opportunity employer and we welcome applications from all backgrounds regardless of race, color, religion, sex, ancestry, age, marital status, sexual orientation, gender identity, disability or any other classification protected by law.
COMPANY BENEFITS:
Fluent provides comprehensive benefits offerings to all full-time employees. Our benefits include medical, dental and vision and supplemental insurance, paid time-off program and non-matching 401k plan.
All applicants must be legally authorized to work in the United States and will be required to submit proof of such eligibility. FLUENT participates in E-verify to ensure a legal workforce. All applicants must be legally authorized to work in the United States and will be required to submit proof of such eligibility.
Please note: Only shortlisted candidates will be contacted
