Description
POSITION TITLE : Quality Manager
REPORTS TO : Technical Manager
QUALIFICATIONS :
- Bachelor's degree with a scientific background is preferred, along with other technical training
and certifications including, but not limited to, knowledge of FDA dietary supplements
requirements (21 CFR Part 111).
1-3 years quality experience in FDA regulated industry.Strong background in quality processes at a cosmetic, food, or dietary supplement manufacturingfacility.
Analytical knowledge for the interpretation of chemical and microbial testing and reports.Adept at technical writing, with experience in writing, reviewing and updating procedures,specifications, policies, etc.
Management or supervisory experience preferred.Must be effective in both written and verbal communication.JOB SUMMARY : DUTIES :
Drive the execution and development of quality systems to comply with regulations and achievecompany 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 operatingprocedures (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 internaland external regulatory compliance, conformance with labeling, product and process
requirements.
Reviews incoming product sampling and testing against established specifications for releasedecisions.
Drive quality processes by maintaining product specifications and quality attributes, documentingevidence, determining operational and performance qualification, writing and updating quality
assurance procedures.
Manages the microbiological testing lab and some analytical and physical lab testing activities.Works closely with analytical contract testing labs to coordinate sample shipping, testingrequirements and test data interpretation.
Provides regular training opportunities for quality and other team members to develop acompliant, collaborative and problem-solving environment.
Provides assistance to document control management personnel.Conducts internal auditing and coordinates environmental monitoring program.Drives company readiness for all quality related audits include but not limited to FDA, 3rd party,and customer audits.
Manages the quality team and ensures adherence to timelines, deliverables, and resources.Responsible for personnel oversight, recruitment, performance management and careerdevelopment of the quality team.
WORK LOCATION : Twin Falls - onsite required
HOURS : Full Time Salaried Position with standard day shift hours with flexibility to support business
priorities as needed.
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 talkand 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 to25 pounds.
