Senior Quality Assurance Specialist
4 weeks ago
Job Title: Senior IT Quality Application Specialist
Location: Irving, TX
Employment Type: W2
Work Model: Onsite
Job Description:
We are seeking an experienced Senior IT Quality Application Specialist to oversee and ensure compliance in Global IT systems, with a primary focus on Manufacturing systems, including Labeling systems and Manufacturing Execution Systems (MES). This role will involve reviewing and approving key documents to ensure compliance with FDA regulations, particularly in relation to manufacturing and labeling processes.
Key Responsibilities:
- Review and approve documentation related to IT quality, including validation protocols, plans, and reports, with a focus on Manufacturing systems like Labeling systems and MES.
- Ensure Global IT systems supporting manufacturing operations meet FDA regulations (21 CFR Part 11, 21 CFR Part 820), ISO standards, and other regulatory requirements.
- Lead the validation efforts for manufacturing IT systems, ensuring alignment with regulatory guidelines and internal SOPs.
- Collaborate with cross-functional teams to support IT system implementation and continuous improvement within manufacturing processes.
- Conduct audits and assessments of IT systems, focusing on compliance with manufacturing system standards.
- Manage risk assessments, CAPAs, and root cause analysis related to manufacturing IT systems incidents.
- Maintain compliance documentation and prepare for audits and regulatory inspections involving IT systems in manufacturing.
Qualifications:
- Bachelor's degree in Information Technology, Computer Science, Life Sciences, or a related field.
- 7-10 years of experience in IT quality management within the Life Sciences industry, with a focus on manufacturing systems.
- Extensive knowledge of FDA regulations (21 CFR Part 11, 21 CFR Part 820) and GxP requirements as they relate to manufacturing and labeling systems.
- Proven experience in the validation and compliance of Manufacturing Execution Systems (MES) and Labeling systems.
- Strong background in documentation review, quality assurance, and change management processes for IT systems in manufacturing.
- Excellent communication and organizational skills with attention to regulatory compliance and manufacturing processes.
Preferred:
- Experience with global IT systems and manufacturing system integrations.
- Previous experience in managing IT systems related to labeling, MES, and other manufacturing processes.
- Certifications in IT Quality, Validation, or FDA Compliance.
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