Annual Product Records Review Associate

Company: Software Galaxy Systems, LLC
Location: Rocky Mount
Posted on: June 17, 2022

Job Description:

Title: Annual Product Records Review Associate Location: Rocky North Carolina 27804 Duration: 18 Months Pay rate: $39/HR on w2 without benefits The job duties include, but are not limited, to the following: - Establish the product matrix and the APRR calendar - Gather the required data and write APRR reports according to the calendar - Analyze trends, make recommendations based on the data in order to improve processes or tools - Send approved reports to clients according to applicable Quality Agreements - Must be able to work and communicate effectively with all levels of people within the other Pfizer sites - Must be able to work and communicate effectively with all levels of people within the Pfizer organization. - Must be able to work and communicate effectively with all types of suppliers to help resolve issues Education Bachelor's Degree with 2+ years working in a GMP FDA regulated environment Minimum of 1 years of experience in one or more of the following: - Quality Engineering/Compliance/Regulatory Affairs - Manufacturing/Technical experience in Pharmaceutical or GxP regulated environment Technical Skills - Strong analytical skills and ability to summaries vast amounts of data - Capacity to manage several projects at a time - Knowledge of the local & international regulatory requirements and Quality Management standards & systems - Strong organizational, presentation, meeting facilitation and technical writing skills. - Possess attention to detail and good communication skills as verbal and written feedback to departments is required when issues are discovered during auditing. - Strong computer proficiency skills in MS Office, Word, Excel, Project, Trackwise (ER / LIR), and Empower LIMS System or equivalent. - ASQ Certification preferred. Job Requirements:

• Title: Annual Product Records Review Associate Location: Rocky North Carolina 27804 Duration: 18 Months Pay rate: $39/HR on w2 without benefits The job duties include, but are not limited, to the following: - Establish the product matrix and the APRR calendar - Gather the required data and write APRR reports according to the calendar - Analyze trends, make recommendations based on the data in order to improve processes or tools - Send approved reports to clients according to applicable Quality Agreements - Must be able to work and communicate effectively with all levels of people within the other Pfizer sites - Must be able to work and communicate effectively with all levels of people within the Pfizer organization. - Must be able to work and communicate effectively with all types of suppliers to help resolve issues Education Bachelor's Degree with 2+ years working in a GMP FDA regulated environment Minimum of 1 years of experience in one or more of the following: - Quality Engineering/Compliance/Regulatory Affairs - Manufacturing/Technical experience in Pharmaceutical or GxP regulated environment Technical Skills - -Strong -analytical skills and ability to summaries vast amounts of data - Capacity to manage several projects at a time - Knowledge of the local & international regulatory requirements and Quality Management standards & systems - -Strong -organizational, presentation, meeting facilitation and technical writing skills. - Possess attention to detail and good communication skills as verbal and written feedback to departments is required when issues are discovered during auditing. - -Strong -computer proficiency skills in MS Office, Word, Excel, Project, Trackwise (ER / LIR), and Empower LIMS System or equivalent. - ASQ Certification preferred.

Keywords: Software Galaxy Systems, LLC, Rocky Mount , Annual Product Records Review Associate, Other , Rocky Mount, North Carolina