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QA Specialist

  1. North America, United States
Ohio
  1. Contract
Competitive
  1. CAPEX Projects
36199
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QA Specialist - Ohio - 12 months contract with potential extensions 

This is a fantastic opportunity for a QA Specialist  to join our major, global pharmaceutical client on their latest new-build project based in Ohio, this is a large-scale greenfield capital project and investing more than $1bn.

Responsibilities:
  • Provide leadership and guidance on all quality-related aspects of laboratory operations.
  • Ensure compliance with GMP, FDA, and other regulatory requirements in lab systems, processes, and documentation.
  • Oversee C&Q, verification, and validation activities, ensuring adherence to internal quality policies and regulatory expectations.
  • Serve as a quality representative during audits and inspections, addressing findings and implementing corrective actions.
  • Lead quality oversight for the commissioning and qualification of lab equipment and systems, including automation and computer systems.
  • Review and approve validation documentation such as URS, FRS, IQ, OQ, and PQ protocols to ensure compliance.
  • Support validation efforts by providing technical expertise on data integrity, electronic records, and compliance with 21 CFR Part 11 and other applicable regulations.
  • Identify potential quality risks and work proactively to implement mitigation strategies.
  • Support CAPA (Corrective and Preventive Actions) processes and investigations related to laboratory operations.
  • Collaborate with stakeholders to drive continuous improvement initiatives while maintaining regulatory compliance.
  • Work closely with cross-functional teams, including engineering, IT, and laboratory staff, to align on quality requirements and expectations.
  • Provide training and mentorship to lab personnel on quality and compliance best practices.
  • Act as a point of contact for quality-related queries and ensure timely resolution of compliance issues.
Skills and Experience:
  • Extensive experience in pharmaceutical manufacturing quality assurance, with experience in laboratory environments preferred.
  • Strong working knowledge of GMP, C&Q, verification, validation, and regulatory compliance requirements.
  • Experience with automation and computer systems validation (CSV) within a GMP environment.
  • Excellent problem-solving skills and ability to work in a dynamic, fast-paced environment.
  • Experience with laboratory automation systems and computerized systems compliance.
  • Familiarity with quality management systems (QMS) such as TrackWise or similar platforms.
  • Strong understanding of data integrity guidelines and electronic documentation management.
  • Ability to lead quality initiatives and process improvement projects.
If this role is of interest, please apply now!
 #LI-AN1


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