Quality Assurance Specialist
5 days ago
Job Summary:
Noven Pharmaceuticals is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality and compliance of our manufactured products.
Key Responsibilities:
- Conduct regular inspections of manufacturing areas to ensure compliance with internal SOPs, cGMPs, and FDA/DEA regulations.
- Review and approve components for in-process operations.
- Monitor and document all work activity in batch records, forms, and logs to ensure accuracy and compliance.
- Sample in-process items and finished products, and perform required inspections and testing.
- Process and distribute samples to different departments.
- Review records for cGMP compliance for accuracy and thoroughness.
- Inform management of problems, failures, and deviations from established internal and regulatory standards.
- Apply disposition stickers to components and in-process materials.
- Issue QA Alerts whenever any questionable component, in-process material, or product is identified at any stage of production or storage.
- Perform swab and Rodac Plate sampling as required.
- Perform transactions in JD Edwards when required.
Requirements:
- High school diploma or equivalent.
- Basic computer skills required.
- Basic math skills required (i.e., calculating percentages, addition, subtraction, multiplication, division).
- Ability to read, write, communicate, and follow instructions (verbal and written) in English.
Work Environment:
The majority of time will be spent at manufacturing plants with exposure to machines with moving parts, airborne products, chemicals, muscular strain, and noise. Carelessness could result in minor injury. May handle or work with laminates and units containing a Class II Controlled Substance.
Physical Demands:
Regularly required to stand for more than one hour at a time; occasionally lifts and carries objects weighing up to 50 pounds. Visual acuity and manual dexterity required to proofread documents and operate a computer.
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