job summary: 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. Focusing on immune diseases like HIV that affect a large percentage of the population, the work our longtime partner conducts is imperative to a better, healthier future. To be recognized as a crucial part to furthering this goal, join this growing team now! location: Cambridge, Massachusetts job type: Contract salary: $55.00 - 60.16 per hour work hours: 9 to 5 education: Bachelors responsibilities: - Approve documents created as part of the validation/ qualification of computerized systems and equipment (e.g. reports/protocols) - Contribute to the development/improvement of computer validation and equipment management methodology as part of the site integration into the GSK standards - Oversee that the R&D data generated electronically (or hybrid process) is obtained, used, back-ups performed and archived in accordance with Data Integrity principles, GxP, corporate and international regulations - Support internal and external audits and contribute to inspection readiness upon request - Support management of deviations and risks to evaluate potential impacts on quality and determine mitigation actions - Provide QA expertise and support to relevant stakeholders qualifications: Education: - Minimum Level of Education - University Degree in Science (Chemistry, Biology, biochemistry, Bioengineer or Pharmacy) Area of Specialization* - Specialization in Vaccines - Life science - Bioinformatics - Computer Engineering - Regulatory - Requirements in Pharmaceutical environment Experience: - At least 5 years' experience in validation methodologies and related documentation (V Cycle, GAMP 5, Agile). Good knowledge of international standards, GXP expectations. Good knowledge of inspection process. Other skills: - Knowledge of R&D environment is beneficial Knowledge in the following areas is beneficial: - Software and hardware development. - Project management and risk management principles and tools. - Spreadsheets validation (Excel, SofMaxPro,...). - Good communication skills are expected as well as a spirit of initiative. - Strong presentation skills. Ability to prepare training content and deliver training session. - Customer focused and flexible thinking - Ability to manage networks and build relationships transversally across the Vaccines network. - Ability to adapt, work under uncertainty and accommodate flexible work demands. - Self-motivated; Sense of urgency. - Knowledge and expertise of quality systems in a pharmaceutical environment, such as, Deviation, Documentation Management, Training, Change Control, CAPA skills: MS-WORD, CAPA, MS-EXCEL, MS-Powerpoint, Biology, Chemistry 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 health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility). Applications accepted on ongoing basis until filled.