job summary: As a trusted staffing and recruitment partner, we are committed to connecting you with the perfect opportunity at a global leader in biotechnology. Leveraging our extensive network, we provide access to top-tier roles that allow you to grow and make a meaningful impact in the healthcare and life sciences industries. This company is dedicated to discovering and developing innovative therapies that address serious diseases, with a focus on oncology, cardiology, and bone health. With a strong legacy of scientific excellence and a mission to improve patient outcomes worldwide, they offer a dynamic environment where your contributions will drive real change. If you're seeking a rewarding career that makes a difference, let us help you take the next step! location: Telecommute job type: Contract salary: $55.00 - 61.96 per hour work hours: 9 to 5 education: Bachelors responsibilities: Act as Quality Assurance (QA) contact for Change Control(s) for Computerized System activitiesReview and Approve validation deliverables (e.g. Validation Plan, Requirement Assessment, support Testing Protocols, Summary Reports, etc.)Change Agent and advocate for the Risk Based Validation programAble to act as SME for multiple Quality processes (e.g. Deviations, CAPA)Review and Approve SOPs and associated documentsReview/Approve Periodic Reviews for GxP SystemsMay perform software Supplier Evaluations as neededSupport project initiatives, process improvements and or projectsMay be required to present on topics or issues to managementMay support audit & Inspections requests as neededMay support other duties as required qualifications: Masters degree in technical or related subject and 3 years with directly experienceBachelors degree in technical or related subject and 5 years with directly experienceWill consider those that have significant years of direct experience in lieu of education requirementsValidation and Change Control experience (Highly preferred: Risk Based Validation experience and or strong Computer System Assurance (CSA) knowledge)Strong organizational skills, including ability to follow assignments through completion.Initiate and lead cross functional teams as neededCollaborate and communicate with higher level outside resources.Strong communication (both written and oral), facilitation, and presentation skills.Strong skill in working independently and to effectively interact with various levels of managementAbility to lead and influence staff outside QA organizationAble to manage performance issues and conflictAbility to evaluate documentation/ operations according to company and regulatory guidelinesAbility to interpret and apply GMP, GLP, GCP, GPvP regulations Preferred Qualification 5+ years experience in a regulated industries in a similar role (e.g. Biotechnology, Medical Device, Aerospace)Demonstrated strong Knowledge of industry and business principlesDemonstrated strong problem-solving abilities and strong risk assessment capabilities skills: Good Laboratory Practices (GLP), SOP Development, Good Clinical Practice (GCP), Good Manufacturing Practices (GMP), Change Control Management, Quality Assurance (QA), Good Documentation Practices (GDP) 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. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.