QA Data/Document Review Associate

American Regent•Shirley, NY

21h•$38 - $42

About The Position

To provide a comprehensive Quality compliance review of cGMP/GxP Analytical Chemistry data and results for raw materials, in-process and finished product release, stability program results and summaries, and raw data related to the Validation of pharmaceutical processes. To facilitate corrections and clarifications to the reviewed data and provide a final approval of the records. Essential Duties and Responsibilities Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Provides quality assurance review of Chemistry laboratory raw data and reports including analytical worksheets, test summaries and stability summaries. Participates in identifying quality process improvements to increase efficiency and performance of systems, operations and personnel relating to the QA Data Review process. Writes and revises SOP’s and other GMP documentation as needed. Ensures all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP, compendia, and all applicable FDA Guidance document requirements and other company requirements. Participates in other Quality System activities with other team members as needed. Perform any other tasks/duties as assigned by management.

Requirements

Bachelor’s degree in the Physical Sciences (preferably Chemistry), Mathematics or related field, or Associate's degree in Science with experience in data review required.
Minimum 2 years experience in a chemical testing, laboratory setting with a working knowledge of wet chemistry (USP/EP) and instrumental analysis techniques (HPLC, UV-Vis, FTIR) , or at least 1 year of Chemistry data review experience.
Demonstrates extreme attention to detail to achieve quality results.
Ability to perform multiple activities at the same time and produce outstanding results to meet required deadlines.
Exercises a willingness to learn and take on added responsibilities as needed.
Excellent organizational, interpersonal and communication skills (oral and written) to work in a team environment.
Ability to work overtime as needed.
Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves.
PPE and Respirators are essential for the health and safety of employees.
Employee must be able to occasionally lift and/or move up to 25 pounds.

Responsibilities

Provides quality assurance review of Chemistry laboratory raw data and reports including analytical worksheets, test summaries and stability summaries.
Participates in identifying quality process improvements to increase efficiency and performance of systems, operations and personnel relating to the QA Data Review process.
Writes and revises SOP’s and other GMP documentation as needed.
Ensures all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP, compendia, and all applicable FDA Guidance document requirements and other company requirements.
Participates in other Quality System activities with other team members as needed.
Perform any other tasks/duties as assigned by management.