QA Quality Analyst

Reference #: 1781192

Advantage Technical is seeking a QA Quality Analyst for our client in Allentown, PA. A quick start and money in your pocket!

Pay: $25-$26 per hour.

Duration: 6-month contract

Shift: Onsite Monday-Friday 8am-5pm

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.