Associate Quality Assurance

Position Title: Associate Quality Assurance
Work Location: Holly Springs, NC, USA 27540
Assignment Duration: 12 months (Possible extension)
Work Schedule: Onsite 5x days a week
Work Arrangement: Onsite

Position Summary: Support inspection, sampling, and testing of raw materials to ensure specification requirements and master inspection characteristics are met for cGMP manufacturing.

Background & Context:

• 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.

Key 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 our organization’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 our organization’s raw material inspections, samples, and testing areas.
• Provide QA oversight to Warehouse and ensure they are adhering to GMP regulations.

Qualification & Experience:

• High school/GED + 2 years work experience or Associates degree and 6 months work experience or Bachelors degree.
• Raman technology understanding, single use inspection experience and gowning experience.

Applicant Notices & Disclaimers

• For information on benefits, equal opportunity employment, and location-specific applicant notices, click
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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position's starting pay is: $26.00/hr