Cannabis jobs at Blaine Labs, Inc

Job DescriptionPosition Title

Department

Reports to

Quality Supervisor

Quality

President/CEO

Employment Status

FLSA Status

Effective Date

Temporary Full-Time Part-Time

Non-Exempt Exempt

2022Position SummaryThe Quality Supervisor will manage the QC labs in support of all QC testing activities from receiving/incoming testing of raw materials to in-process testing to finished goods testing. They will be responsible for ensuring overall compliance manufacturing of the QC labs, ensure SOP’s are accurate and up to date, QC test equipment is calibrated and all QC personnel are fully trained. In addition, the quality control and assurance supervisor/FDA regulatory specialist will be responsible for ensuring all testing is prioritized based on the business needs and both shifts are adequately staffed. Additional responsibilities include process improvements, assess lean operations of the lab process, coordinating testing with outside labs, vendor qualification and addressing issues with outside lab testing, interact with department heads to ensure optimal flow of material in QC labs, lead internal/external audits, ensure compliance to GMP and other regulatory requirements, department training and SOP maintenance, quality data trending, setting department goals, assessing and tracking non-conformances, CAPA’s and attending/participating in both MRB’s and Daily Management.Essential Duties and ResponsibilitiesThe essential functions include, but are not limited to the following:

• Oversee all manufacturing for GMP compliance
• Schedule QC tests and ensure completeness, timeliness and overall compliance.
• Coordinates activities of raw material, finished product and microbiology staff in testing incoming raw materials and components, and finished product. Coordinates with manufacturing and packaging for production schedule, material and finished product testing. Coordinates with quality assurance department regarding release of raw materials/ components and finished product for release and distribution.
• Coordinates with manufacturing and packaging for production schedule, material and finished product testing.
• Coordinates with quality assurance department regarding release of raw materials/ components and finished product for release and distribution.
• Ensure cGMP compliance in all aspects of laboratory operations
• Maintain and keep up-to-date with Company facility registrations
• Evaluate design changes, labels, literature, and website for accuracy, consistency, and regulatory compliance
• Observes and follows company guidelines, SOPs, policies, procedures and FDA regulations.
• Develop, improve and implement SOPs for various quality control operational procedures including training, trending, equipment maintenance and calibration, method execution, investigations, and laboratory processes. Creates and revises raw material, component and finished product specification forms and worksheets.
• Investigate out-of-specification results and write investigation reports.
• Perform data review, trending analyses and prepare protocols and report to support all areas of laboratory operations.
• Recruit and develop a high performing team with diverse backgrounds and talents. Conducts regular training for the quality control group.
• Coach and counsel team members to develop their skill sets and create an environment of continuous learning, improvement and innovation.
• Maintain and communicate performance metrics for the team, setting and maintaining high expectations for team performance.
• Develop and drive staff schedules to meet workflow demands and monitors expenditures to prevent budget overruns.
• Provide technical guidance to QC and serves as subject matter expert in cross functional, cross departmental work teams.
• Performs other duties inherent of the position, and additional duties that may be assigned by supervisor.

Minimum Qualifications (Knowledge, Skills, and Abilities)

• FDA: Must have 3-5 years experience in reviewing, correcting, and ensuring compliance for FDA audits
• Cannabis/Hemp/CBD: 3-5 years in FDA regulatory compliance (Preferred)
• Quality Certs CQE, CQA etc.: 4 years (Preferred)
• Excel: 5 years (Preferred)
• Quality Control: 5 years (Preferred)
• Should know QSR 820 and Pharma 211 Quality, regulatory and be able to complete and manage the company's SOPs.

Education, Training and experience

• B/S or higher Science or Technical Degree
• Quality Certifications a plus (CQE, CQA etc.)
• 3-5+ years’ experience working in an FDA regulated industry.
• Computer Proficient with Microsoft Office, Excel and other software’s necessary to work as a Compliance Officer

Physical Demands and Work EnvironmentThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions. While performing the duties of this position, the employee is regularly required to talk or hear. The employee frequently is required to use hands or fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, and the ability to adjust focus. The noise level in the work environment is usually low to moderate.NoteThis job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. All duties and responsibilities are essential functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbents will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. This document does not create an employment contract, implied or otherwise, other than an “at will” relationship.Reviewed with employee bySignature: _______________________________ Name (print): ________________________________ Title: _____________________________________________________ Date: _____________________Received and accepted bySignature: _______________________________ Name (print): ________________________________ Title: _____________________________________________________ Date: _____________________The company is an Equal Opportunity Employer, drug free workplace, and complies with ADA regulations as applicable.

Job Types: Full-time, Contract

Schedule:

• 8 hour shift
• Monday to Friday

Ability to commute/relocate:

• Santa Fe Springs, CA 90670: Reliably commute or planning to relocate before starting work (Preferred)

Experience:

• ISO 9001: 1 year (Preferred)

Work Location: One location

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