Data Integrity Specialist III

Top Skills

• GMP Lab Experience 6+ years
• Documentation Review
• Empower
• LIMS
• Electronic Lab Notebook

• Serve as compliance specialist for the QC lab including routine assessment of lab compliance, monthly communication to lab management regarding compliance concerns, ensure lab managers complete quarterly LIR and data review checklists, and serve as coordinator for any lab specific audits as needed.
• Coordinate lab review of compendial changes to evaluate impact and assign verification testing as needed.
• Serve as calibration coordinator for lab including approval and scheduling of service requests, impact assessment of demand maintenance on instrument qualification status, assignment, review, and approval of instrument related investigations, and creation of work orders in Maximo to capture vendor visits/maintenance as well as adding new instruments and decommissioning old instruments as needed.
• Work collaboratively with multiple parties to ensure appropriate instrumentation is procured, installed, calibrated and qualified according to company procedures.
• Perform assessments of QC documents (i.e. methods, qualification protocols, calibration documents, etc.) to determine compliance to processes and regulations to identify potential gaps. Mitigate and implement improvements within the quality system.
• Lead project teams in planning, preparation, review, and approval of quality documentation related to calibration requests.
• Participate on validation review board as area validation for equipment qualifications.
• Assist in the design of effective quality systems, procedures, and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality system.
• May be asked to assist in development, revision, or implementation (including delivering training) of training modules, videos, and documents to the local and to global labs.

• Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area preferred.
• 4+ years’ experience in quality assurance, quality oversight or relevant experience.
• Knowledge and familiarity with product testing, test method requirements, and capabilities of common lab instrumentation is preferred.
• Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting device, biologics, and pharmaceutical products preferred.
• Experience leading teams to deliver tactical results.
• Strong oral and written communication skills.
• Good interpersonal skills.

EEO:
“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”