Data Integrity Specialist III

1 year initial contract
Cincinnati, OH
$31.00-34.00/HR
Orion Group is hiring for a GxP Data Integrity Specialist to join our multinational pharmaceutical client in Cincinnati, OH
The GxP Data Integrity Specialist will be an individual contributor within an R&D Scientific Compliance group that supports a broad variety of topics and processes.
The GxP Data Integrity Specialist is responsible for planning, coordinating, and/or implementing initiatives that provide quality assurance support for QC Lab Operations.
Specific areas of support may include:
GMP/Compliance; Change Management, Lab Equipment/Instrument procurement, installation, calibration, validation/qualification, Training and other QC Lab support projects.
This position will help to ensure that the QC Labs operate in compliance with corporate and governmental regulations.
GxP Data Integrity Specialist Responsibilities:

• 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 workorders in Maximo.
• 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.

GxP Data Integrity Qualifications:

• Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/ scientific area.
• In-depth GxP Data Integrity understanding in a biopharma industry (at least 1 year experience)
• 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.
• Laboratories Systems/software support, Direct experience with SNOW and or KNEAT as well as platforms, e.g.,), Microsoft365 and/or SharePoint applications
• Familiarity with general scientific terminology, e.g., chemist, biologist, instrument, analytical testing, study, clinical, active ingredient, drug products.
• Experience leading teams to deliver tactical results.
• Strong oral and written communication skills.

People are our business worldwide
 
Orion Group was founded in 1987 and is now one of the largest, independent, international recruitment companies. We have a network of 200 employees working from 24 offices, delivering a range of services – Talent Acquisition, Recruitment Outsourcing Services, Retained Search, Global Workforce Solutions, Completions & Commissioning and Materials Management – across 68 countries. As a global leader in workforce solutions, we recruit personnel across the Engineering & Technical, Office & Commercial, Scientific and Skilled Trades disciplines, for sectors including Oil & Gas, Life Science, Power & Utilities, Constructions & Infrastructure, Manufacturing and Renewables.