As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you!
location: Newark, Delaware
job type: Contract
salary: $75.00 - 80.29 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- CAPA Review Board - prepare material, generate data for charts (21 data sets / charts), analyze trends, provide talking points, load minutes and attendance to Agile
- KPI Meeting - prepare material, generate data for charts (duplicates CRB except 2 NCE charts), analyze trends, and provide talking points
- Process change orders for Corporate CAPA and NCE documents
- Corporate CAPA and NCE procedures and work instructions
- Agile-CAPA and Agile-NCE validation and specification documents
- Administrative files for Agile-CAPA and Agile-NCE, e.g. Dropdown lists
- Facilitating CAPAs and NCEs
- Preparing and distributing quarterly Overdue CAPA/IACA report
- Preparing and distributing monthly CAPA Aging report to QLT
- Review and approving Agile access requests - CAPA, NCE
- Periodic review of open COR, CAPA, and NCEs (globally)
- Validate and test Agile-CAPA and Agile-NCE tool changes
- Author validation/specification documents for Agile-CAPA and Agile-NCE, e.g. SRS, SDD
- Maintain CAPA/NCE SharePoint page
- Collaborate with AI team to establish AI proof of concept for identifying potential compliance issues in CAPAs
- Ad hoc data analysis
qualifications:
- Education: Bachelor's degree in a technical, scientific, or business discipline.
- Quality Systems: Strong experience managing CAPA (Corrective and Preventive Action) and NCE (Non-Conformance) processes within a regulated industry (e.g., ISO 13485 or FDA 21 CFR 820).
- Software Proficiency: Power-user experience with Oracle Agile PLM and data visualization tools for generating KPI charts and trend reports.
- Technical Writing: Proven ability to author validation and specification documents, including SRS (System Requirements) and SDD (Software Design).
- Data Analysis: Sharp analytical skills for monitoring global compliance trends and collaborating on AI-driven process improvements.
skills: PV CAPA Management, Corrective and Preventive Actions (CAPA)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
