- Assist with single-use material qualification including documentation and data entry to ensure all proposed changes are accurately captured and reviewed for material qualification needs.
- Support data entry and administration of engineering change proposals in the Quality Management System (QMS) software Trackwise.
- Meet cross-functionally to review supplier change notifications for single-use materials.
- Collaborate cross-functionally to compile material qualification data and revise material specifications in the Veeva document management system (DMS).
- Collaborate with stakeholders to identify specific requirements for forms related to instrument calibration, material numbering, new spare parts, or equipment bill of material.
- Process and route forms ensuring timely reviews and approvals by relevant stakeholders and ensure they meet the requirements of local procedures and compliance requirements.
- Enter proposed change control plans into the Trackwise software and act as administrator to track and document execution of the project deliverables.
- Support tracking and trending process equipment work orders.
- Interpret vender spare parts lists and draft proposed preventative maintenance plans with guidance from area-owner engineers.
- Compile data for process equipment maintenance assessments or periodic review reports.
- Draft equipment bill of materials lists to link spare parts with associated equipment.
- Report progress / metrics to help identify efficiency improvement ideas within the engineering administration business practices.
- Complete mandatory training within required timeframe
shift: First
work hours: 8 AM - 5 PM
education: Associate
Responsibilities
- Assist with single-use material qualification including documentation and data entry to ensure all proposed changes are accurately captured and reviewed for material qualification needs.
- Support data entry and administration of engineering change proposals in the Quality Management System (QMS) software Trackwise.
- Meet cross-functionally to review supplier change notifications for single-use materials.
- Collaborate cross-functionally to compile material qualification data and revise material specifications in the Veeva document management system (DMS).
- Collaborate with stakeholders to identify specific requirements for forms related to instrument calibration, material numbering, new spare parts, or equipment bill of material.
- Process and route forms ensuring timely reviews and approvals by relevant stakeholders and ensure they meet the requirements of local procedures and compliance requirements.
- Enter proposed change control plans into the Trackwise software and act as administrator to track and document execution of the project deliverables.
- Support tracking and trending process equipment work orders.
- Interpret vender spare parts lists and draft proposed preventative maintenance plans with guidance from area-owner engineers.
- Compile data for process equipment maintenance assessments or periodic review reports.
- working in a smoke free environment
Skills
- Quality Management
- Problem Solving
- GMP
- Preparing Agendas
- Interpersonal Skills
- Organizational Skills
- Conflict Resolution
- Data Entry
- Documentation
- Microsoft Office
- Trackwise
- Document Revisions
- Veeva Document Management
- Multi-tasking
- GMP Pharma Experience
Qualifications
- Years of experience: 5 years
- Experience level: Experienced
Randstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad.
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.
