Global Product Quality Specialist

Global Product Quality Specialist12-month ContractRemote- EST HoursResponsibilities:Quality Systems Support:Work collaboratively with internal and external partners to ensure deviations, investigations, OOS/OOTs, CAPAs and change controls adhere to quality system requirements and current GMP expectations.Support of regulatory submissions, annual reports and preparation of annual product quality reviewsInspection readiness for Internal and external auditsCompile metrics for continuous improvement initiativesAssist in the writing of Quality AgreementsDocumentation Review:Review of API, DP and Packaging batch recordsReview of test methods, component specifications, validation protocols/reports, BOMReview of stability protocols and reports, and data in LIMSOperational QA Support:Work with external CDMOs and laboratories in the review of quality events, change controls, data review, and batch record documentationCreates and/or ensures on-time closure of Quality records in TrackWise Digital (batch records, deviations, change controls, investigations, CAPAs and effectiveness checks)Uploads and routes documents for approval in the company Electric Documentation Management System (Veeva) and DocuSignProject QA Support:Represent quality on cross-functional teams and provide support to ensure compliance with GMPs, FDA expectations, product specific requirements, and company standards are consistently metEnsure the review and release of clinical and commercial lots meet expected timelines to maintain an uninterrupted product supplyQualifications:BS Degree in scientific discipline (e.g., Chemistry, Biology, Pharmacy, Engineering) or equivalent experience in a GMP-regulated environment4 to 7 years of experience working within Pharmaceutical Quality, Engineering, Production or QC/Analytical Development functionAbility to author and/or provide clear, concise, and technically accurate feedback on GMP documents (SOPs, deviations, CAPAs, investigations, protocols, reports)Attention to detail required to perform thorough document review, accurate data verification, and consistent application of right first time principlesWorking knowledge of ICH guidelines (e.g., Q7/Q8/Q9/Q10, Q12) and 21 CFR Parts 210/211 and/or EU GMPs, with the ability to apply these requirements to real-world manufacturing, testing, documentation, and release processesExperience with at least two QMS elements (e.g. Deviation, CAPA, Change Control)Strong written and verbal communication skills; ability to collaborate with cross-functional teamsProficiency with MS 365 (Word, Excel, PowerPoint, SharePoint/Teams).Experience with electronic QMS/eDMS (TrackWise, Veeva, LIMS) systems is a plus.