We are seeking a Clinical and Health - Data Auditor for a very important client.

Summary

Provides support for analytical data review in a fast-paced GMP laboratory environment. Authors Standard Operating Procedures, Deviation/ Discrepancy Reports, Change Controls, Corrective and Preventive Actions, and Risk Assessments. Supports continuous improvement initiatives while maintaining quality.

Essential Functions

1. Critically reviews testing from the following instrumentation: HPLC, GC, PXRD, Dissolution, DSC, FT-IR and KF.

2. Ensures analytical test results comply with internal specifications as well as company and regulatory standards.

3. Collaborates with internal scientific, analytical, laboratory and quality functional areas to meet project and team objectives.

4. Works closely with, and collaborates with, the Data Integrity Officer and escalates any quality concerns as appropriate to the Quality Unit.

5. Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, and safety guidelines.

6. Maintains the necessary compliance status required by company and facility standards.

7. Working knowledge of Empower or other LMS.

Education

Bachelor of Science in Chemistry, Biochemistry, Biology, Computer, or related science required.

Experience

Some lab experience preferred (2 years). Experience with Empower. Experience performing or reviewing chemical tests with chromatographic, spectroscopic, or other analytical technique preferred. Equivalent combinations of education, training, and relevant work experience may be considered.

Equivalency

Equivalent combinations of education, training, and relevant work experience may be considered.

Competencies

• Good work ethic and a desire to learn.

• Ability to multi-task and handle shifting priorities in a fast-paced, highly regulated manufacturing environment.

• Effective written and interpersonal skills.

• Attention to detail and the ability to follow written and verbal instructions.

• Excellent critical and logical thinking skills to solve problems.

• Experience with Microsoft Excel, Word, PowerPoint.

• Good knowledge of qualitative and quantitative chemical analysis as it relates to the pharmaceutical industry.

• Understanding of GMP and data integrity (ALCOA).

• Ability to read, analyze, and interpret technical procedures and governmental regulations.

• Ability to write standard operating procedures, protocols, and reports.

Looking for chemistry or similar background & experience with empower lab data acquisition systems.

Physical Requirements

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.

Disclaimer

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.