job summary: The Sr. Specialist, Quality Assurance will support and provide oversight for QA operations on the floor activities, Disposition, Technology Transfer and/or Change Control activities at our cGMP Manufacturing site specifically raw material disposition and QA warehouse oversight. This role will ensure quality oversight of mRNA drug substances and products, maintaining stringent adherence to a Quality System that respects global regulatory expectations. The successful candidate will be versatile, resilient, and responsive to change, managing shifting project timelines and priorities effectively. location: Norwood, Massachusetts job type: Contract salary: $50 - 60 per hour work hours: 9 to 5 education: Bachelors responsibilities: Provide quality oversight for manufacturing and packaging operations, ensuring compliance with cGMP regulations.Partner closely with peers for the disposition of Raw Materials.Participate in quality-focused teams across Moderna's broad ecosystem of functions.Author and review SOPs, policies, and batch production/testing records to ensure compliance with cGMP operations.Enforce adherence to current good manufacturing practices and establish written procedures for accurate documentation.Oversee and review executed electronic and paper batch record documentation.Review and approve manufacturing deviations and enforce adherence to current good manufacturing practices, SOPs, and manufacturing documentation and operations including modeling clean room behaviors. Author, review, and approve SOPs, policies, and batch production/testing records.Support manufacturing improvement initiatives and Technology Transfer projects.Review technical qualification protocols and reports (IQ/OQ/PQ).Identify, classify, and report deviations; oversee execution of remediation/CAPA activities.Ensure timely closure of investigations, working closely with cross-functional teams to determine root causes and implement corrective actions.Support the site's contamination control program through training, documentation, and SME support.Conduct microbiological risk assessments and evaluate overall facility contamination control strategies.Perform and approve batch disposition activities.Collaborate fluidly with peers, supervisors, and cross-functional teams including Quality Control, Manufacturing, Logistics, and Process Development.Demonstrate strong decision-making skills and independent thinking in a fast-paced environment.Responsible for training adherenceAdherence to data integrity principlesEscalation of manufacturing, safety and quality concerns to department managementMonitor process operations to ensure compliance with specifications.Practice safe work habits and adhere to safety procedures and guidelines.Utilize knowledge to improve operational efficiency.Participate in the quality oversight of manufacturing through real-time observations of activities.Perform review and release of Raw Materials and streamline procedures for the rejection and destruction of Raw Materials and Consumables.Identify, classify, and report deviations as appropriate.Develop batch records, SOPs, and training materials for startup activities.Participate in internal and external audits for compliance with SOPs, GMPs, and regulations. General understanding of health authority regulations and how to apply them internally.Leads projects with cross functional teams, able to lead and manage projects end to end.Ability to contribute to continuous improvement projects and support multiple projects at the same time.Act as a SME and resource for new hiresProblem solving for complex issues and ability to drive corrective actionParticipate in quality-focused teams to drive continuous improvement and operational excellence. qualifications: Qualifications Bachelor's Degree or equivalent years of experienceExperience: 3-6 Years experience in the biotechnology/biopharmaceutical industry, or other regulated industry.Preferably in Quality Assurance and/or Training / document control.Preference: Experience in biopharmaceutical & GMP. #LI-LH1 skills: SOP Development, Good Manufacturing Practices (GMP), Corrective and Preventive Actions (CAPA), Deviation Investigation, Quality Assurance (QA), Raw Materials 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.