QC, Bulk/Finished Product Data Reviewer

Location: Buena, NJ

Job Summary

The Bulk/Finished Product Data Reviewer is responsible for the review of all bulk and finished product testing. They will also be responsible for all protocols, reports and Deficiency Responses as needed.

Essential Responsibilities

  • Responsible for tracking when testing results will be available.
  • Responsible for reviewing and approving all bulk and finished product testing that is performed via the laboratory notebook and in LIMS. This includes physical and analytical testing.
  • Responsible for ensuring that all testing is reviewed and approved in accordance with the shipping schedule.
  • Responsible for creating all protocols and reports for the Quality Control unit.
  • Responsible for pulling and sending all data required to Regulatory Affairs for ANDA submissions and performing all corrects accordingly.
  • Responsible for all Deficiency and Information Requests from the FDA.
  • Maintain up to date documentation.
  • Maintain and follow all laboratory systems, GMPS and safety requirements.
  • Keep Supervisor/Manager informed of all key quality findings and issues.
  • Assume other activities and responsibilities from time to time as assigned.

Qualifications

  • BS in Chemistry or related discipline, 3-5 years of pharmaceutical industry or laboratory experience.
  • Knowledge of cGMPs and good documentation practices
  • Strong foundation in analytical chemistry and quantitative analysis.
  • Collaborative working style.  Demonstrates professionalism, cooperation and willingness to support team members and company priorities
  • Well-developed interpersonal skills.  Ability to get along with diverse personalities.
  • Good written and oral communication skills.
  • Demonstrated ability to work on multiple projects and meet timelines

Physical Demands/Factors

  • While performing the duties of this job, the employee is regularly required to stand.  The employee is frequently required to walk; sit; use hands; talk; and hear.  The employee is occasionally required to reach with hands and arms; climb or balance; stoop; kneel; crouch. The employee must occasionally lift and or move up to 25 pounds.  Specific vision abilities required by this job include close vision, distance vision, and color vision.
  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs

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