Associate Quality Assurance

Job Summary

The role will support the inspection, sampling, and testing of raw materials that are received at the North Carolina site. This role will ensure that raw materials received for use in our cGMP manufacturing plants meet all specification requirements and master inspections characteristics required for use in our manufacturing process. This role will also demonstrate leadership skills in support of scheduling, coordination, and staff training. There will be opportunities to advance Quality learning through additional responsibilities and training.

location: Apex, North Carolina

job type: Contract

salary: $25.00 - 30.15 per hour

work hours: 9 to 5

education: High School

Responsibilities

• Inspect materials including biobags, tubing, filters, and other components to ensure all inspection-related specification requirements and master inspections characteristics are met
• Remove samples from containers of medias and other chemicals to facilitate the testing of samples
• Use RAMAN technology with TruScan equipment to identify chemicals
• Ensure that inspection & sampling results are complete and detailed according to written procedures and cGMP requirements
• Responsible for accurately documenting inspection, sample, and test results in Company's systems
• Responsible for ensuring that characteristics that could potentially impact product quality are assessed according to procedures
• Ability to determine the color of components match required attributes
• Support inspection readiness activities
• Supports Continual Improvement initiatives, programs and projects
• Assist area management with the prioritization and scheduling of tasks
• Serve as a trainer in tasks associated with raw material inspections, samples, and testing
• Own controlled documents for the area including SOPs and FORMs
• Initiate and own deviation records and CAPAs associated with events and projects in ANC's raw material inspections, samples, and testing areas
• Provide QA oversight to Warehouse and ensure they are adhering to GMP regulations.
  
  

Qualifications

Required:

• High school/GED 2 years work experience OR Associate's 6 months work experience OR Bachelor's degree.
• Strong cGMP/GDP knowledge; SAP, LIMS, TrackWise experience.
• Experience with RAMAN (TruScan) and SOP creation.
• Experience in raw material inspection, sampling, and testing.
• 1 year relevant pharma work experience
  
  

skills: SOP, Quality Assurance, CAPA, Laboratory Information Management Systems (LIMS), GMP (Good Manufacturing Practice)

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.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

This posting is open for thirty (30) days.

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