job summary: QA Senior Associate will be responsible for Quality On the Floor in support of Manufacturing activities. Shift: This position works a rotating night shift (C shift), with five day working during one week (M, Tu, F, Sa, Su) and two days the following week (W, Th), shift hours are 7pm to 7am, with adaptability as required based on the business needs location: West Greenwich, Rhode Island job type: Contract salary: $34.00 - 40.23 per hour work hours: 9 to 5 education: Bachelors responsibilities: This position provides the opportunity to work directly with Manufacturing staff during bulk drug substance operations to facilitate batch record and attachment reviews, logbook reviews, area changeover reviews, real-time decision-making regarding quality incidents.This is a unique opportunity to foster a strong partnership and learning environment between Manufacturing and Quality staff.Responsible for providing Quality oversight to ensure that operations products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations.Ensure that facilities, equipment, materials, organization, processes, procedures, and products comply with cGMP practices and other applicable regulations.Performs review and approval of cGMP processes, procedures, documents, and records, including but not limited to Standard Operating Procedures (SOPs), Batch Records, and Deviations.Author/review/approve quality documents, such as: SOPs, risk assessments, training materials, engineering documents, automation documents, protocols/reports.Provide guidance during on-the-floor analytical testing.Ensure that changes that could potentially impact product quality are assessed according to procedures.Ensure that deviations from established procedures are investigated and documented per procedures.Review executed batch records, attachments, and area logbooks.Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.Alerts senior management of quality, compliance, supply, and safety risks.Completes required assigned training to permit execution of required tasks.Drive operational improvement initiatives, programs, and projects. qualifications: Masters degree OR Bachelors degree and 2 years of experience (in QA or MFG) OR Associates degree and 6 years of experience (in QA or MFG).Experience in Biotech or Pharmaceutical industry. skills: 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.