Overview
QA Document Reviewer Jobs in Cincinnati, OH at ViTalent
Title: QA Document Reviewer
Company: ViTalent
Location: Cincinnati, OH
ViTalent Consulting Group is a premier professional services organization that specializes in engineering and technical services consulting for Life Sciences. Our organizational goal is to impact lives as a long term partner for both talent and organizations.
We are currently seeking a QA Document Reviewer to support a critical capital project at a biopharmaceutical manufacturing site. This onsite consulting role will focus on the review and approval of validation documentation to ensure compliance with internal quality standards and regulatory requirements.RESPONSIBILITIES:
Review and approve validation-related documentation (URS, IQ/OQ/PQ protocols, risk assessments, etc.) for a major capital project, ensuring compliance with cGMP, regulatory, and internal standards
Provide timely, constructive guidance to document authors and stakeholders during the review phase
Escalate discrepancies to the project team and QA Director; partner with validation and engineering teams to drive resolution
Attend weekly 1:1 meetings with the QA Director, as requested
Process, edit, verify, and manage documents in the electronic documentation system, including procedures, specifications, test methods, and production control records
Ensure alignment of documentation with systems such as SAP, LIMS, MES/POMS, and Delta V
Route change control packages for review and approval; monitor responsiveness of approvers and ensure timely completion
Support training efforts related to the document change process, as needed
May be asked to collaborate with QA teams at other manufacturing sites to support consistency in documentation practices
QUALIFICATIONS:
Bachelor’s Degree in Engineering, Science, or closely related discipline is desired, or equivalent technical experience plus demonstrated competence.
Experience working in a cGMP-regulated pharmaceutical, biotech, or life sciences manufacturing environment
Strong working knowledge of computerized systems and Good Manufacturing Practices (GMP)
Familiarity with document control systems and platforms such as SAP, LIMS, MES/POMS, or Delta V
Proficiency in Microsoft Word, Excel, and electronic documentation systems
Excellent written and verbal communication skills, with a detail-oriented approach and strong organizational abilities
All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.
Applicants must be authorized to work for any employer in the United States. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
Interested, qualified candidates please complete our online application. We look forward to getting to know you as you consider next steps in your career.
