job summary: This role offers the chance to be a key player in Quality Engineering, ensuring the integrity of critical equipment and processes for both commercial and clinical cell/gene therapy products. You'll directly contribute to bringing life-changing therapies to patients by supporting the tech transfer of groundbreaking treatments. location: Philadelphia, Pennsylvania job type: Contract salary: $60 - 65 per hour work hours: 9 to 5 education: Bachelors responsibilities: Responsible for QA review and approval of all validation records and documentation (i.e. process validation, computer system validation, and equipment lifecycle documentation including but not limited to URS, DQ, FAT, SAT, IQ, OQ, PQ, and PV protocols and reports)Assist in the monitoring of quarterly reports, periodic reviews and/or revalidation of equipment and processes.Review and approve protocol discrepancies related to manufacturing process equipment, utilities, computer systems, validation, and laboratory instruments.Ensure GMP compliance in all areas of validation/qualification and that systems are fully validated/qualified and all documentation completed before they are released for GMP use.Liaise with key personnel within project teams to ensure validation tasks are completed in a timely manner.Review the content of technical lifecycle documentation (i.e. Characterization Study Protocols/ Reports, QTPP, PPQ Protocols/Reports, Control Strategy Documents, etc) ensuring compliance with the validated state of the process. qualifications: REQUIRED: Bachelor's Degree in Science or related technical field.5+ years of Quality Assurance/Validation experience in the biotechnology or pharmaceutical industries.GMP experienceStrong understanding of QA principles, industry practices, and standards with demonstrated ability to apply these to GMP operations is required. skills: Quality Assurance, GMP (Good Manufacturing Practice) 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.