Quality Assurance Specialist

Quality Assurance SpecialistThe 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.ResponsibilitiesEnsure 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 QualificationsProven 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 Company's 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 PowerPointTop 3 Must Have Skill SetsWarehousingRaw material incoming inspection and samplingRaw material dispositionThe typical base pay for this role across the U.S. is: $30.00 - $33.00 /hr. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law.Consent to Communication and Use of AI Technology: By submitting your application for this position and providing your email address(es) and/or phone number(s), you consent to receive text (SMS), email, and/or voice communication whether automated (including auto telephone dialing systems or automatic text messaging systems), pre-recorded, AI-assisted, or individually initiated from Aditi Consulting, our agents, representatives, or affiliates at the phone number and/or email address you have provided. These communications may include information about potential opportunities and information. Message and data rates may apply. Message frequency may vary. You represent and warrant that the email address(es) and/or telephone number(s) you provided to us belong to you and that you are permitted to receive calls, text (SMS) messages, and/or emails at these contacts. You also acknowledge and agree to Aditi Consulting LLC's use of AI technology during the sourcing process, including calls from an AI Voice Recruiter. AI is used solely to gather data and does not replace human-based decision-making in employment decisions. Calls may be recorded. Consent is not a condition of purchasing any property, goods, or services. You may revoke your consent at any time by replying "STOP" to messages or by contacting View email address on click.appcast.io. For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy.