QA Annual Product Review Coordinator
Akorn 2

Decatur, Illinois

This job has expired.


Position will complete Annual Product Reviews within the QA Department. Responsibilities include compiling product data for review period including batches manufactured, manufacturing and laboratory investigation, product quality complaints, stability data, change controls, validation activities etc. The individual will also be responsible for reviewing, and generating the final report summarizing product trends and product performance, in addition to supporting QA’s involvement in the Change Control Process.

• Ensures adherence to established SOPs for conducting and generating Annual Product Review Reports.
• Reviews, summarizes and generates a management report of product data.
• Experienced at preparing executive summaries for individual products.
• Functions as a liaison between several internal departments.
• Produces a final report for review and approval in a timely manner identifying any negative trends indicating. concerns for product quality and initiating corrective actions upon management approval.
• Participates, leads and/or coordinates meetings related to the APR Process.
• Assist in QA Change Control Process.
• Assist during FDA inspections pertaining to training.
• Assist in other QA functions as deemed necessary.
• Write, Review, and Implement SOP’s to ensure compliance with Regulation and High Tech Policies.

Qualifications

  • Minimum of Bachelor's Degree in a scientific discipline.
  • Minimum 5 years of experience in pharmaceuticals or related industry.
  • Working knowledge of cGMP regulations.
  • Experience in compiling Annual Product Reviews
  • Technical writing skills preferred
  • Experience in trending and use of trending tools
  • Strong verbal and written communication skills


Company Overview
Akorn, Inc. is a niche pharmaceutical company that develops, manufactures and markets generic and branded prescription pharmaceuticals as well as animal and consumer health products. We specialize in difficult-to-manufacture sterile and non-sterile dosage forms including: ophthalmics, injectables, oral liquids, topicals, inhalants, and nasal sprays. Akorn markets its products to retail pharmacies, ophthalmologists, optometrists, physicians, veterinarians, hospitals, clinics, wholesalers, distributors, group purchasing organizations, and government agencies.

EEO Statement
Akorn, Inc. is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.


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