Nanotherapeutics

Your Biopharmaceutical Development and Manufacturing Partner

Quality Assurance Compliance Specialist/Auditor (II or III)

Responsibilities and Authority:

  • Monitor and continuously improve the Quality System by evaluating supporting documentation to ensure compliance to cGMP, industry standards and other applicable regulations.
  • Write and review standard operating procedures, test methods, work instructions, forms, material specification sheets, master batch records, and production batch records, CAPA’s, change controls and Quality Agreements
  • Master Batch Record /Production Batch Record Review
  • Develop all necessary documents to meet project timelines 
  • Assist in internal and external audits 
  • Perform inspection and release for product.
  • Provide cGMP and other Quality related training 
  • Document and check returns and complaints
  • Project/monthly progress reports
  • Perform tracking and trending analysis

Minimum Educational and Experience Requirements for Competency:

  • Minimum BS degree required
  • Good communication and organization skills
  • Must have excellent attention to detail
  • Proficient in Microsoft Word and Excel and able to input data into other Microsoft programs 
  • Minimum 5 years experience in biologics or pharmaceutical Quality Assurance preferred.

This position will be based in Alachua, FL.

To apply submit your resume to careers@nanotherapeutics.com with the position in the subject line.

Nanotherapeutics is an equal employment opportunity for all without regard to race, color, religion, sex, age, national origin, disability, or any other characteristic protected by applicable law. If you need assistance in applying for a position, please contact us through careers@nanotherapeutics.com or call 386-462-9663.

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