QA Data/Document Review Associate

Nature and Scope

To provide a comprehensive Quality compliance review of cGMP analytical 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 laboratory raw data and reports including environmental monitoring and microbiological worksheets, test summaries, and trending data (for microbiological related data).
• Participates in identifying quality process improvements to increase efficiencies 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. Initiate and complete CR process.
• 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. Perform cGMP training to analysts.
• Participates in other Quality System activities with other team members as needed.

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

• We all must embrace the QUALITY culture.

 Qualifications and Requirements

• Bachelor’s degree in the Biological, Physical Sciences, Mathematics or related field or Associate Degree with experience in data review required.
• Minimum 2 years experience of microbiological experience in practices 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 producing 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.

 Physical Environment and Physical Requirements

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

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