Specialist Quality Assurance

Quality Assurance SpecialistDuration: 18 months contractThe ideal candidate will have 5+ years of QA experience specifically involving raw materials in a GMP-regulated environment such as pharmaceutical, biotech, or other life sciences industries. A bachelor's degree is strongly preferred; master's candidates may be considered, but Ph.D.-level talent may be too senior for the scope. This role is physically active and requires passing an eye exam, lifting materials (~40 lbs), and consistent gowning (jumpsuit, scrubs, goggles). While officially remote (per internal classification), the worker must be onsite daily. Candidates must be local or self-relocate, no exceptions. Strong attention to detail, comfort in a warehouse environment, and GMP compliance experience are essential. Avoid candidates seeking remote-only work or lacking QA/GMP/raw material background.Responsibilities:Ensure that all operations comply with relevant regulations and requirements, including Safety, Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and Good Documentation PracticesConduct sampling and inspection of incoming raw materials, assess documentation, and determine dispositionCompile and review documentation associated with receipt, storage, incoming inspection, and distributionPerform routine Quality Assurance assessments and provide direct operational oversightProvide expert advice on quality matters to operational teams and cross-functional groupsEnsure staff complete necessary training related to business operationsApprove GMP processes, procedures, documents, and records, addressing deviations, CAPAs, change controls, risk assessments, and validation records as requiredAchieve established metric targets and develop standardized approaches for tracking progressCollaborate with Logistic Service Providers (LSPs) to maintain service levels and identify areas for performance enhancementRepresent the Quality Unit during audits and inspections, directly interacting with regulatory agenciesSupport internal and external audits and inspections as a member of the audit/inspection teamPerform additional duties as assigned by managementPreferred Qualifications:Proven ability to communicate effectively with cross-functional teams and diverse cultures, both verbally and in writingAcademic background in Life Sciences, Physical Sciences, Applied Engineering, or Manufacturing TechnologiesPrior experience overseeing QA in distribution, warehousing, manufacturing, validation, and engineering functionsExpertise in managing deviations, change controls, and CAPAsProficiency in Veeva, SM LIMS, and ERP systemsKnowledge of industry standards (GMP, GDP, Import/Export)Commitment to exemplifying core valuesDemonstrated self-leadership and motivationStrong strategic thinking skillsAbility to evaluate compliance issues and engage with regulatory inspectorsExperience managing multiple priorities within a dynamic environmentDirect experience with drug substances and/or drug productsAdvanced problem-solving abilities and capacity for scientific, risk-based decision-makingTrack record of representing an organization during regulatory interactionsHigh proficiency in Microsoft Excel, Word, and PowerPointBasic Qualifications:Doctorate degree ORMaster's degree and 3 years of experience ORBachelor's degree and 5 years of experience ORAssociate degree and 10 years of experience ORHigh school diploma / GED and 12 years of experienceTop 3 Must Have Skill Sets:WarehousingRaw material incoming inspection and samplingRaw material dispositionDay to Day Responsibilities:Warehouse and raw material incoming inspection and sampling oversight and raw material dispositionUS Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.By applying, you acknowledge that AI-assisted tools may be used during hiring.