Quality Control Specialist

Reports To: Director of Quality
Essential Duties and Responsibilities

The Quality Control Specialist coordinates and performs quality control processes; executes sound quality policies to ensure safety and quality of products and performs other related other duties as required.

Additional Duties and Responsibilities
  • Coordinates the application of the Quality System requirements for determining that in process and finished goods comply with established specifications, standards, and
    regulations for OTC and Cosmetic requirements (I.e. cGMP, FDA, MOCRA).
  • Supports Validation activities.
  • Responsible for ensuring Quality maintenance and issuance for Controlled Documentation.
  • Assures adequate sampling plans, inspection procedures and test methods are implemented.
  • Continuously improves the execution of Quality Systems and business processes, including product controls to achieve quality goals and maintain Regulatory Compliance.
  • Provide support and direction for new products, and processes.
  • Oversee the product release to ensure that safe and effective product is distributed to customers. Responsible for approval or rejection of components/materials, finished products, and documents to achieve this purpose.
  • Perform training coordinator responsibilities, ensuring personnel in the plant are trained to adequately perform their assigned responsibilities.
  • Overall responsibility and ownership of material release and final disposition activities.
  • Maintain safety, hazardous waste according to EH&S procedures.
  • Other duties as assigned.
Requirements (Education, Certificates, Licenses, Registrations, etc.)
  • A minimum of a bachelor’s degree in science, engineering, other relevant discipline; minimum of 3 years’ experience working in an FDA or ISO regulated environment; or equivalent combination of education and experience.
  • Ability to analyze information and act on results.
  • Ability to work well with people at all levels within the organization.
  • Accuracy and attention to detail.
Language Skills

Ability to read, analyze and interpret technical procedures or governmental regulations. Ability to write reports as well as business correspondence. Ability to effectively communicate in English. Spanish language / bilingual is a plus.

Computer Skills

Ability to use word processing, spreadsheet, and database applications. Ability to learn various software programs.

Physical Demands and Work Environment

The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of the job, the employee is regularly required to sit, talk and hear, lift and/or move up to 40 pounds, stand, walk, climb or balance in conditions that include stairs, uneven ground, walking between buildings, etc. Normal vision is required for this job (with corrective lenses if necessary).

This position is offered at $20-$23 per hour as a full-time position (M-F, 7:30-4:30) with benefits including medical, dental, vision, paid time off and paid holidays