job summary: We are seeking a highly skilled and experienced Senior QA Specialist to join our dynamic team. In this role, you will be responsible for overseeing the quality assurance process, supporting batch disposition of drug substance, ensuring that our products meet both Local and Global quality standards. location: Cambridge, Massachusetts job type: Contract salary: $59.00 - 61.63 per hour work hours: 9 to 5 education: Bachelors responsibilities: - Support batch release of drug substance including compilation of documentation and review of batch documentation (i.e. batch records, deviations, in-process EM) - Perform review of the manufacturing batch records for completeness and compliance with cGMPs as per regulatory requirements and internal procedures. - Support SAP integration and master data migration for batch release activities - Working knowledge and/or ownership of the following quality systems: Change Control, CAPAs, Deviations, and Self inspection auditing, QA reporting and approval of GMP documentation. - Support GMP compliance and inspection readiness within organization. Assist in coordination of work for the QA Operations team to facilitate timely release of product lots. qualifications: Required: - HS Diploma or equivalent and 8+ years of experience in a cGMP environment, OR associate degree and 6+ years of experience in a cGMP environment, OR bachelor's degree and 4+ years of experience in a cGMP environment. - Previous experience working with quality systems having oversight of cGMP production operations including some or all of the following: batch release, SAP, batch record review Preferred Qualifications: - Demonstrated experience in regulatory inspection activities. - Working knowledge of cGMPs and associated regulatory requirements for the manufacture, testing, and release of pharmaceutical/biopharmaceutical products for international markets. - SAP knowledge - Root cause analysis experience - Vaccines experience a plus. #LI-JW1 skills: Quality control, Quality Assurance, CAPA, 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 health, an incentive and recognition program, and 401K contribution (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.