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QA Specialist

  1. North America, United States
Ohio
  1. Contract
Competitive
  1. CAPEX Projects
36198
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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 quality assurance oversight for C&Q, verification, and validation activities, ensuring compliance with GMP, FDA, and other regulatory requirements.
  • Collaborate with engineering, operations, and IT teams to ensure the implementation of quality standards in automated and computer-controlled systems.
  • Ensure all quality activities are conducted following applicable policies, procedures, and regulatory expectations.
  • Support regulatory inspections and audits, providing documentation and responses as required.
  • Lead and provide oversight for commissioning, qualification, and validation of warehouse equipment and systems.
  • Review and approve validation documentation, including URS, FRS, IQ, OQ, and PQ protocols.
  • Ensure appropriate risk-based approaches are applied to validation and verification activities.
  • Monitor and assess changes to computerized systems and automated processes to ensure continued compliance.
  • Identify opportunities for quality improvements and implement corrective and preventive actions (CAPAs).
  • Support the development and implementation of quality systems, including change control, deviations, and investigations.
  • Provide input into process optimization initiatives to enhance operational efficiency while maintaining compliance.
  • Act as a quality advocate, providing guidance to project teams, suppliers, and stakeholders on quality and compliance matters.
  • Participate in cross-functional project meetings to ensure quality considerations are integrated into project deliverables.
  • Provide training and mentorship to team members on quality expectations and regulatory requirements.
Skills and Experience:
  • Bachelor's degree in a scientific field (Engineering, Biology, Chemistry, or related disciplines) or equivalent experience.
  • Strong knowledge of pharmaceutical quality systems and GMP regulations, with experience in manufacturing environments.
  • Previous experience with C&Q, verification, and validation oversight, particularly in automation and computer systems validation (CSV).
  • Ability to work independently while collaborating with cross-functional teams to ensure compliance and quality objectives are met.
  • Excellent documentation skills and attention to detail, with experience in writing and reviewing technical reports.
  • Willingness to work 3 days per week on-site or 2 weeks on / 2 weeks off schedule.
  • Experience with quality oversight in warehouse or logistics operations within pharmaceutical manufacturing.
  • Knowledge of industry standards such as GAMP 5, 21 CFR Part 11, Annex 11, and relevant data integrity guidelines.
  • Strong problem-solving and critical-thinking skills to address quality challenges proactively.
  • Experience with electronic quality management systems (eQMS) and document control systems.
If this role is of interest, please apply now!

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