Looking to secure a high-visibility footprint in Philadelphia's premier cell and gene therapy hub? A cutting-edge biopharmaceutical facility at the Navy Yard has an immediate, 5-month opening for a GMP Quality Systems & Equipment Specialist.
This role features a streamlined interview process for an immediate start. While the immediate mission focuses on clearing a critical operational backlog, successfully driving this project to the finish line directly positions you for upcoming, long-term equipment qualification and computer systems validation (CSV) expansions into next year.
location: Philadelphia, Pennsylvania
job type: Contract
salary: $50 - 60 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Perform comprehensive Quality Assurance review, verification, and formal sign-off for a high-volume backlog of equipment-related work orders covering routine calibrations, preventative maintenance (PM), and critical corrective repairs.
- Maintain data integrity and end-to-end quality oversight within the site's Computerized Maintenance Management System (CMMS), ensuring all asset data entries conform strictly to local Good Manufacturing Practices (GMP) and data integrity expectations.
- Evaluate, author, or review cross-functional investigations, deviations, Corrective and Preventive Actions (CAPAs), and change controls directly triggered by equipment failures, vendor maintenance variances, or out-of-tolerance (OOT) calibrations.
- Analyze raw data sheets and calibration certificates provided by third-party maintenance vendors to ensure testing parameters, accuracy tolerances, and traceability requirements align perfectly with validation protocols and engineering standards.
- Interface actively with manufacturing operations, quality control, facilities engineering, and third-party calibration vendors to keep the high-priority maintenance and equipment-clearance timeline on track without disrupting active production schedules.
- Ensure all legacy, current, and incoming equipment maintenance logs, vendor records, and CMMS entries are fully audit-ready and compliant with global clinical and commercial cell therapy regulatory standards (e.g., FDA, EMA).
qualifications:
- Bachelor's Degree in Science, Engineering, or a related technical field.
- Minimum of 3-5 years of Quality Assurance or Quality Engineering experience within a regulated cGMP biotechnology or pharmaceutical manufacturing environment.
- Must be local to the Philadelphia metro area to meet the 3 days/week on-site requirement at the Navy Yard.
skills: Equipment Validation
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.
Any consideration of a background check would be an individualized assessment based on the applicant or employee's specific record and the duties and requirements of the specific job.
