Description:
Note:
Monday-Friday completely on-site in Holly Springs,NC

Job Details:

• 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.

Primary Responsibilities of the Role Include:

• 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 Amgen’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.
• Maintains project plan commitments supporting critical projects
• Coordinates with other functional areas on IQA scheduling.
• Supports Continual Improvement initiatives, programs and projects
• Assist area management with the prioritization and scheduling of tasks
• Serve as a trainer and subject matter expert in tasks associated with raw material inspections, samples, and testing
• Own/Review 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.

Basic Qualifications        

• High school/GED + 4 years work experience or Associate + 2 years work experience or Bachelor + 6 months work experience or Masters Degree.

Top 3 Must Have Skill Sets:        

• Strong understanding of cGMP regulations and GDP requirements
• SAP, LIMs, and TrackWise experience
• Experience with RAMAN technology and TruScan
• Experience as a Trainer in raw material inspections, sampling, and testing
• Strong written and verbal communication skills

Pay Rate  between $30 - $35/Hr on W2 based on experience.

"This posting is for Contingent Worker, not an FTE"