QA Quality Analyst

Advantage Technical is seeking a QA Quality Analyst for our client in Allentown, PA.

Job Function - General:

• Review and analyze documentation, procedures, and systems related to data integrity to identify potential gaps or deficiencies.

• Prepare data Integrity gap assessment checklist as per protocol for evaluating data integrity practices across different departments and processes within the organization.

• Conduct assessments of data Integrity practices to ensure compliance with regulatory requirements, including FDA data integrity guidelines, 21 CFR Part 11, and other relevant standards.

• Collaborate with cross-functional teams including SMEs, Quality Assurance, IT, and Regulatory Affairs, to initiate data integrity assessment phase and communicate identified issues and implement corrective actions.

• Monitor, track, and communicate progress of data integrity assessment, effectiveness of corrective actions and continuous improvement efforts as per assignment.

• Stay updated on changes to regulatory requirements and industry best practices related to data integrity and incorporate them into assessment processes and procedures.

• Prepare and present reports on assessment findings, recommendations, and compliance status to management as needed.

• The function listed is not exhaustive and shall also include any responsibilities as assigned by the reporting Manager

• Qualifications:

• Bachelor's degree in a relevant scientific discipline, such as Pharmacy, Chemistry, Biology, or Information Technology.

• Minimum of 2 years of experience in a pharmaceutical or biotechnology industry setting, with a focus on data integrity, quality assurance, or regulatory affairs.

• In-depth knowledge of data integrity regulations and guidelines, including FDA data integrity guidance, EU GMP Annex 11, and PIC/S guidance.

• Strong understanding of electronic document management systems, and laboratory systems and Manufacturing systems.

• Excellent analytical skills and attention to detail, with the ability to identify and resolve complex data integrity issues. Proficient in utilizing Microsoft Office, Microsoft Project, and SharePoint.

• Effective communication and interpersonal skills, with the ability to collaborate with cross-functional teams and communicate technical information to non-technical stakeholders.

• Experience conducting assessments, audits, or inspections related to data integrity and quality management systems

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