QA Data/Document Review Associate - EM/Microbiology

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.

• 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).

• Communicates any audit comments/ observations/ findings during review to respective stakeholders and get them corrected

• Informs the supervisors/manager immediately of any critical data integrity issues or data irregularity.

• 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 (Good Manufacturing Practices) documentation as needed. Initiate and complete Change Request process.

• 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.

• 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.

• Perform any other tasks/duties as assigned by management.

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.

• Bachelor's degree in the Biological, Physical Sciences, Mathematics, or related field, or Associate Degree with experience in data review 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.

• 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 participate in 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.

Expected hourly range:

$37.55 - $40.00

The hourly range displayed is the minimum and maximum hourly rate for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate's qualifications, education, knowledge, skills and experience.

American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits.

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.

Applicants have rights under Federal Employment Laws.

• FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
• Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
• Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

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 hrtalentacquisition@americanregent.com.