Randstad Quality Control Specialist in Fenton, Missouri

Quality Control Specialist

job details:

  • location:Fenton, MO

  • salary:$40,000 - $45,000 per year

  • date posted:Friday, January 4, 2019

  • experience:5 Years

  • job type:Permanent

  • industry:Professional, Scientific, and Technical Services

  • reference:27388

job description

Quality Control Specialist

job summary:

Our client has a great opportunity to expand its US operations by 50% in 2019. They are looking for candidates that are excited about the opportunity to help them reach those goals in 2019, 2020 and beyond. They are looking for a Quality Specialist to support the Head of Quality and Compliance in assuring that requirements of the Code of Federal Regulations are met and to Ensure that daily Quality Assurance Departmental activities support operational requirements

location: Fenton, Missouri

job type: Permanent

salary: $40,000 - 45,000 per year

work hours: 9 to 5

education: Bachelors

responsibilities:

  • 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 (component 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

qualifications:

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

skills: Quality control

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.