Infotree Global Solutions
Quality Assurance Associate
Infotree Global Solutions, Raleigh, North Carolina, United States, 27601
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Infotree Global Solutions provided pay range This range is provided by Infotree Global Solutions. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $32.00/hr - $35.00/hr
Job Summary We are seeking a detail-oriented and proactive QA Associate (Biologics) to support data migration, batch record review, and release activities. This role plays a key part in enhancing operational efficiency through accurate documentation, effective use of document management systems, and development of tracking tools.
The ideal candidate will have hands‑on experience in Quality Assurance within the pharmaceutical or biotech industry, strong technical and organizational skills, and familiarity with systems such as Veeva Vault and SAP. Proficiency in Excel is required, and experience with Power BI for data visualization and reporting is preferred.
Key Responsibilities
Lead and manage the migration of quality documents into Veeva Vault, ensuring accuracy, compliance, and traceability.
Support the transition of legacy records and maintain completeness and integrity of documentation.
Build and maintain trackers to monitor key performance indicators (KPIs), batch record status, and release metrics.
Perform batch record reviews to ensure documentation completeness and compliance for batch release.
Collaborate cross-functionally with QA, MSAT, QC, and Supply teams to support release readiness and process improvement.
Requirements Education:
Associate degree (required); Bachelor’s degree in Life Sciences or a related field (preferred).
Technical Qualifications:
Minimum 3 years of experience in Quality Assurance within an FDA-regulated pharmaceutical/biotech environment.
Experience with batch record review, document control, and release processes.
Familiarity with SAP and Veeva Quality systems.
Knowledge of Power BI is preferred, but not mandatory.
Key Skills:
Strong organizational, communication, and technical writing abilities.
Self‑directed, goal‑oriented, and quality‑conscious professional.
Demonstrated ability to work collaboratively across QA, MSAT, QC, and Supply functions.
Seniority Level Mid‑Senior level
Employment Type Contract
Job Function Quality Assurance
Industries Biotechnology Research, Pharmaceutical Manufacturing, and Research Services
Location and Pay Raleigh-Durham-Chapel Hill Area, $32.00–$35.00/hr
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Infotree Global Solutions provided pay range This range is provided by Infotree Global Solutions. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $32.00/hr - $35.00/hr
Job Summary We are seeking a detail-oriented and proactive QA Associate (Biologics) to support data migration, batch record review, and release activities. This role plays a key part in enhancing operational efficiency through accurate documentation, effective use of document management systems, and development of tracking tools.
The ideal candidate will have hands‑on experience in Quality Assurance within the pharmaceutical or biotech industry, strong technical and organizational skills, and familiarity with systems such as Veeva Vault and SAP. Proficiency in Excel is required, and experience with Power BI for data visualization and reporting is preferred.
Key Responsibilities
Lead and manage the migration of quality documents into Veeva Vault, ensuring accuracy, compliance, and traceability.
Support the transition of legacy records and maintain completeness and integrity of documentation.
Build and maintain trackers to monitor key performance indicators (KPIs), batch record status, and release metrics.
Perform batch record reviews to ensure documentation completeness and compliance for batch release.
Collaborate cross-functionally with QA, MSAT, QC, and Supply teams to support release readiness and process improvement.
Requirements Education:
Associate degree (required); Bachelor’s degree in Life Sciences or a related field (preferred).
Technical Qualifications:
Minimum 3 years of experience in Quality Assurance within an FDA-regulated pharmaceutical/biotech environment.
Experience with batch record review, document control, and release processes.
Familiarity with SAP and Veeva Quality systems.
Knowledge of Power BI is preferred, but not mandatory.
Key Skills:
Strong organizational, communication, and technical writing abilities.
Self‑directed, goal‑oriented, and quality‑conscious professional.
Demonstrated ability to work collaboratively across QA, MSAT, QC, and Supply functions.
Seniority Level Mid‑Senior level
Employment Type Contract
Job Function Quality Assurance
Industries Biotechnology Research, Pharmaceutical Manufacturing, and Research Services
Location and Pay Raleigh-Durham-Chapel Hill Area, $32.00–$35.00/hr
#J-18808-Ljbffr