Senior Associate, QA - GMP

Senior Associate, QA - GMPLocation: West Greenwich, RIOnsite Flexibility: OnsiteContract DetailsPosition Type: ContractContract Duration: 13 monthsPay Rate: $23.00–$26.00 / Hour (USD)Shift / Schedule: Rotating shift schedule — Week 1: Monday, Tuesday, Friday, Saturday; Week 2: Sunday, Wednesday, Thursday; ~12 hours per day, 6:45 AM – 7:00 PMWork Authorization: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.Job SummaryIn this vital role, you will be responsible for PQA (Plant Quality Assurance) on the Floor in support of Manufacturing activities. This position requires working directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements and deviations.Key ResponsibilitiesProvide Quality oversight for Manufacturing operations to ensure that products are manufactured, tested, stored, and distributed according to current applicable regulations.Ensure that facilities, equipment, materials, organization, processes, procedures, and products follow cGMP practices and other applicable regulations.Perform review and approval of cGMP processes, procedures, documents, and records. Review logbooks, batch records, attachments, work orders, and other GMP documentation.Ensure that deviations from established procedures are documented per procedures.Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.Alert management to quality, compliance, supply, and safety risks.Complete required assigned training to permit execution of required tasks.Responsible for being in clean room space for majority of time on shift which includes gowning in and out of frocks and coveralls.Communicating and collaborating with the PQA shift to ensure required tasks are completed.Day to Day Responsibilities:Quality Oversight (including Purposeful Presence on the Floor) of bulk drug substance manufacturing operations.GMP documentation review/approval (including EURs, electronic logbooks, RT reports, Work Orders, batch records, etc.).Interim and reject cage management.Required SkillscGMP experience (must have)Experience collaborating within and across functional areas and demonstrated customer service focusAbility to prioritize and navigate ambiguity, with minimal oversight, in a fast-paced environmentIndependent but able to work within a team structureProficient in Microsoft Office (e.g., Outlook, Word, Excel, PowerPoint, MS Teams)Knowledge of data integrity requirementsExcellent written and verbal communication skillsPreferred SkillsExperience working in a cGMP environmentExperience with decision-makingExperience with analytical testing and/or general compendia testingExperience working with batch records and other GMP documentationKnowledge of data integrity requirementsProficient in Microsoft Office (e.g., Outlook, Word, Excel, PowerPoint, MS Teams)Experience collaborating within and across functional areas and demonstrated customer service focusExcellent written and verbal communication skillsAbility to prioritize and navigate ambiguity, with minimal oversight, in a fast-paced environmentEducation RequirementsHigh school diploma / GED and 4 years of work experience, ORAssociate degree and 2 years of work experience, ORBachelor's degree and 6 months of work experience, ORMaster's degreeRequired ExperienceGMP experience is required; no previous experience working in a GMP-regulated industry is a disqualifier.Academic background in Sciences is expected.Must be a team player; individual contributors not sought.Nice-to-Have ExperienceBachelor's degree and 2 years of Quality/Manufacturing work experienceImportant NotesInterview Process: Video conference — 1 interview with the hiring manager.BenefitsMedical, Vision, and Dental Insurance Plans401k Retirement FundAbout GTTGTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. We highly value diverse and inclusive workplaces and support Fortune 500 organizations across banking, financial services, technology, life sciences, biotech, utilities, and retail sectors throughout the U.S. and Canada.Job Number: 26-16893 Industry: Manufacturing & Operations