AR&D Auditor

Research & Development Philadelphia, Pennsylvania


Description

Position Summary:

Reviews analytical test methods, laboratory notebooks, analytical reports, SOPs, and other relevant documents to ensure adherence to cGMP guidelines and established specifications and standards.

 

Reporting:

ARD Management

 

Essential Duties & Responsibilities                                                                                                                           

 

1.

Perform review of analytical test methods and analytical reports as part of the ARD change control process. These methods must be reviewed with respect to the “justification” of the change and may include reviewing compendia requirements, method validation reports, and other requirements as necessary

2.

Perform primary auditing of the AR&D notebooks (for test data of IP, FP, API and Excipients)

 

3.

Perform secondary auditing of outside (contract lab) data.

4.

Review method validation raw data and notebooks per respective method validation protocols

5.

Ensure review is performed on time, accurately, and in compliance with relevant requirements.

6.

Keep abreast of all relevant compendia and regulatory requirements and assist in ensuring compliance.

7.

Perform primary auditing of Analytical Report result sheets and Stability Summary Report result sheets.

8.

Notify Supervisors/Management of any product quality issues identified during auditing.

9.

Assist in training of new auditors when required.

10.

Perform other duties as assigned.

 

Position Requirements

Education:

·        Bachelor's Degree or equivalent in Chemistry or other sciences

Experience Required:

·        3-5 years of experience in the pharmaceutical industry with BS

·        Experience working in pharmaceutical industry and/or analytical laboratory is highly desirable

·        Quality Control or Analytical R&D documentation experiences with thorough knowledge of SOP’s, cGMP, ICH, USP, and FDA compliance

·        Good working knowledge of HPLC, GC, UV/Vis, and other analytical instruments

·        Good knowledge and experience in In-Process (IP), Finished Product (FP), Raw Material (API) and Excipient testing (Wet chemistry) including all Physical testing.

·        Good knowledge of Empower 3 system for chromatographic analysis (HPLC, UPLC, GC).

Competencies:

        Competency                                                           Proficiency Level

·        Job Knowledge                                                       Intermediate  

·        Excellence in Execution                                        Intermediate

·        Communication/Teamwork                                Intermediate

·        Internal/External Customer Focus                     Intermediate

·        Leadership                                                               Basic

 

Performance:

·        Maintains confidentiality

·        Comply with all cGMP requirements and Company policies, procedures, rules and regulations

·        Possesses sound documentation and writing skills

·        Communicates effectively

·        Demonstrates ability to prioritize conflicting demands

·        Executes assigned tasks within established schedule

·        Competency with MS Word and Excel

·        Knowledgeable with MS Office