Quality Assurance Manager - Canyonside Labs

DUTIES:

• Drive the execution of quality systems and management/work processes to achieve company goals and objectives.
• Aids with developing and implementing the quality management system to assure product safety, product quality, and regulatory compliance.
• Provide guidance, leadership, and assistance in problem solving efforts for standard operating procedures (SOPs), Good Manufacturing Practices (GMP), and Dietary Supplement standards and process improvements.
• Aid with the development of auditing and reporting processes to provide assurance of internal and external regulatory compliance, conformance with labeling, product and process requirements.
• Reviews product sampling and testing against established specifications.
• Manages the Non-Conforming and Holds programs.
• Drive quality processes by maintaining product specifications and quality attributes, documenting evidence, determining operational and performance qualification, writing and updating quality assurance procedures.
• Manages the Microbiological labs as well as some Analytic lab duties.
• Reviews quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, recalls, corrective actions, and re-validations.
• Provides regular training opportunities for QA and other impacted team members to help foster a compliant, collaborative problem-solving environment.
• Provides assistance to document control management personnel.
• Conducts internal auditing and implements an environmental monitoring program.
• Drives company readiness for all quality related audits include but not limited to FDA, 3rd party, customer and Kosher audits.
• Manages the quality team and ensures adherence to timelines, deliverables, and resources.
• Responsible for personnel oversight, hiring, termination, performance reviews, and career track development of the quality team.

QUALIFICATIONS:

• Bachelor’s degree with a scientific background is preferred, along with other technical training and certifications including but not limited to knowledge associated with FSMA and FDA dietary supplements requirements.
• 1-3 years quality assurance experience in FDA regulated preferred. Strong background in QA processes at a cosmetic, food, or dietary supplement manufacturing facility is desired.
• Adept at technical writing, with experience in writing, reviewing and updating procedures, specifications, policies, etc.
• Management or supervisory experience preferred.
• Experience using G Suite and Asana preferred.
• Must be effective in both written and verbal communication.

PHYSICAL REQUIREMENTS: 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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Employee is occasionally required to sit for extended periods of time and may be required to talk and listen to employees.
• Employee is frequently required to stand for long periods of time.
• Employee must regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds.