Quality Assurance Associate - Biotechnology

Quality Assurance Associate Job OpportunityLocation: Fully Onsite in Malvern, PAShift: 1st Shift (M-F)Compensation: $33.65/hr to $38.46/hr.Exact compensation may vary based on several factors, including skills, experience, and education.Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.Required QualificationsBachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Biochemistry, Microbiology, or related field)Minimum of 2 years of experience in a GMP pharmaceutical or biotechnology environmentExperience in QA, QC oversight, raw material release, or laboratory data reviewStrong understanding of GMP documentation and regulated quality systemsAbility to read, interpret, and apply SOPs, work instructions, test methods, and protocolsDemonstrated critical thinking, problem‑solving, and sound judgmentComfort working in a fully on‑site environment and collaborating cross‑functionallyPreferred QualificationsExperience reviewing Certificates of Analysis (CoAs)Exposure to raw material quality, supplier quality, or warehouse QA oversightExperience using SAP in quality or release workflowsFamiliarity with LIMS or laboratory data systemsExperience supporting commercial GMP manufacturing environmentsPosition SummaryThe Quality Assurance Associate provides QA oversight and release support for raw materials and related quality activities across laboratory, warehouse, and supplier‑facing functions. This role supports raw material release, Certificate of Analysis (CoA) review, and quality oversight activities, while also providing flexible support to other QA operational needs as business priorities evolve.This position is intentionally designed to be cross‑trained, supporting multiple QA functions rather than a single, siloed task. The role does not independently author investigations or CAPAs, but contributes to quality decision‑making through documentation review, issue identification, and appropriate escalation.Key ResponsibilitiesRaw Material Release & QA OversightPerform QA review of raw material documentation, including Certificates of Analysis (CoAs), supplier test data, and associated data packagesSupport raw material disposition and release activities in accordance with GMP requirements and internal quality systemsReview internal and external laboratory testing data supporting material release decisionsCell Banking / CoA Review SupportSupport QA review and approval workflows for Cell Banking CoA documentationApply transferable release and data review skills across both raw material and cell banking processesSupplier & Program Quality SupportProvide QA oversight support for supplier quality programs, including origin bag and related material programsPartner with other QA teams to support shared quality responsibilities across organizationsIdentify documentation gaps, quality risks, and compliance concerns and escalate appropriatelyInspection & Sampling OversightProvide QA oversight support for QC inspection and sampling activities occurring in warehouse or laboratory environmentsReview inspection documentation to ensure adherence to procedures and regulatory expectationsGeneral QA Operations SupportSupport additional QA operational activities as assigned, excluding independent deviation, investigation, or CAPA authorshipParticipate in cross‑training to ensure coverage across multiple QA functionsMaintain compliant training status and adhere to cGMP, safety, and quality system requirements