Overview
QA Specialist Jobs in Ohio, United States at QCS Staffing
Title: QA Specialist
Company: QCS Staffing
Location: Ohio, United States
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!
