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Qa Data/Document Review Associate - Em/Microbiology

Company

American Regent, Inc.
Address , Shirley, Ny
Employment type FULL_TIME
Salary
Expires 2023-07-23
Posted at 11 months ago
Job Description
Nature and Scope
This position will provide a comprehensive Quality compliance review of Environmental Monitoring data in LIMS (Laboratory Information Management System) & logbooks, cGMP Microbiology Lab analytical data & results for raw materials, in-process and finished product release, stability program results and summaries 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.
  • Communicates any audit comments/ observations/ findings during review to respective stakeholders and get them corrected
  • Perform any other tasks/duties as assigned by management.
  • Extend help in collecting EM/PM data for investigation and author Investigation.
  • Ensures all work is performed and documented according to existing Company policies and procedures, cGMP, compendia, and all applicable FDA (Food and Drug Administration) Guidance document requirements. Perform cGMP training for department.
  • Participates in other Quality System activities with other team members as needed.
  • Provides quality assurance review of laboratory raw data and reports including environmental monitoring and microbiological worksheets, test summaries, and trending data (for microbiological related data).
  • Ensures compliance with cGMP/cGLP and good documentation procedure during the review process
  • Follow SOPs (Standard Operating Procedure) and Safety Guidelines to ensure compliance within a cGMP environment.
  • Informs the supervisors/manager immediately of any critical data integrity issues or data irregularity.
  • Writes and revises SOP’s and other GMP (Good Manufacturing Practices) documentation as needed. Initiate and complete Change Request process.
  • Participates in identifying quality process improvements to increase efficiency and performance of systems, operations and personnel relating to the QA Data Review process.
Education Requirements and Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.
  • Ability to work overtime as needed.
  • Bachelor’s degree in the Biological, Physical Sciences, Mathematics, or related field or Associate Degree with experience in data review required.
  • Exercises a willingness to learn and participate in added responsibilities as needed.
  • Excellent organizational, interpersonal, and communication skills (oral and written) to work in a team environment.
  • Demonstrates extreme attention to detail to achieve quality results.
  • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.
  • Minimum 2 years of microbiological experience in areas such as gram stains, plate counts, manufacturing of media, environmental monitoring, and microbiological assays or at least 1 year of data review experience.
  • Ability to perform multiple activities at the same time and produce outstanding results to meet required deadlines.
American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.
American Regent Inc. endeavors to make
https://americanregent.com/Careers
accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email .