Quality Assurance Specialist

Fenton, MO

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Description

Remedy Staffing has 1st Shift Job Openings for a Quality Control Specialist in Fenton, MO. 

Hours: 8:00 am - 4:30 pm

Pay: $12.00/hr. 

Primary Functions of the Position:

  • Support Head of Quality and Compliance in assuring that requirements of the Code of Federal Regulations are met
  • Ensure that daily Quality Assurance Departmental activities support operational requirements (componentry inspection and release, document control system, label issuance/control, etc.)
  • Oversee and perform the inspection of all componentry, labeling, etc. to assure compliance with approved specifications
  • Oversee and perform batch record issuance/review to ensure all products meet company/regulatory standards and customer expectations
  • Complete investigations and failure analyses so that root causes for deviations are understood and eliminated where possible
  • Write standard operating procedures
  • Perform document/record control to include:
    • Standard Operating Procedures
    • Processing and packaging batch records, labels, inserts, and other printed materials
    • Study protocols
    • Validations
  • Manage label control program to assure compliance with issuance accountability, change and processing controls
  • Review and Approve laboratory method validation activities
  • Review and evaluate laboratory procedures
  • Disposition raw materials for use in pharmaceutical goods
  • Other duties, which may be assigned from time to time

Job Requirements

Skills and Abilities Required:

  • Knowledge of Federal and State Regulations
  • Knowledge of pharmaceutical manufacturing practices, validation methods, inspection and testing methodologies
  • Strong communication skills
  • Possess excellent computer (MS office: word; excel; access; outlook), writing and editing skills

Minimum Education and Experience Required:

  • Minimum Education: Bachelor’s degree
  • Minimum 2-6 years Quality Assurance experience in a regulated environment

Physical Requirements:

  • Lifting of approximately 30 pounds
  • Ability to work in FDA regulated cGMP manufacturing, warehouse, laboratory and office environment.  Including requirements listed in 21 CFR.
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