Sr. Quality Assurance for Quality Control - Biopharma - Contract

Sr. Quality Assurance for Quality Control - Biopharma - Contract Sanford, United States | Posted on 03/04/2026 Industry Pharma/Biotech/Clinical Research Work Experience 4-5 years City Sanford State/Province North Carolina Country United States About Us AtBiostrategenix, we believe thatsimplicity is the key to quality compliance. Our philosophy is grounded inlean principles, where every process is designed to reduce complexity, eliminate waste and enhance value.We approach quality with clarity and purpose by designing systems that are intuitive, scalable, and aligned with global regulatory expectations. Our goal is to empower our clients' teams with tools and processes that workforthem, not against them. In this way, the solutions we implement endure the test of time. Job Description Biostrategenix LLC is hiring NOW for a contract, on-site role for aSenior Quality Assurance professional specializing in Quality Controlfor a large bio-pharmaceutical client. The contract, on-site role isbased in Sanford, North Carolina. This role provides quality assurancefor Quality Control (QC) departments that supports end-to-endmanufacturing activities for both clinical and commercial products.Thus, in this role, you will oversee quality control and qualityassurance processes, ensuring compliance with Good ManufacturingPractice (GMP) standards, review and approve procedures and documents,QC equipment qualifications, material, process control documents,deviations, CAPAs and change controls. What You Will Be Doing As part of the Quality Assurance team, you will Maintain regulatory compliance in accordance with cGMPs Contribute to completion of projects, manage your timeappropriately to meet agreed targets, and develop plan for workactivities on your own assignments/projects within a team Review and approve campaign related documentation as requiredsuch as MBRs, sample plans, analytical/QC documentation, LIMSbuilds, potential to SAP builds, stability protocols, andtechnical documents, and all associated to QC support Review and approve deviations, complaints, laboratoryinvestigations, or any other associate documents that require aRoot Cause Analysis for a proper CAPA and effectiveness check Review and approve changes controls and provide impactassessments as required Drive compliance, efficiency and process improvement projects Represent QA in Tier meetings (triage, analytical, technical,and process robustness team meetings) Participate in cross-functional teams as required wherequality representation is required; interface with R&D, QC,Operations, Engineering, Supply Chain, Technical Operations,Regulatory Affairs, as applicable Escalate issues on time to management, as appropriate, andseek feedback in a timely manner Perform and assist with additional duties as needed Requirements What We Are Looking For Education BS/BA in science/related field and 5+ years of experience inbio-pharmaceutical/pharmaceutical industry MS/MA in science/related field and 3+ years of experience inbio-pharmaceutical/pharmaceutical industry Strongly Preferred Experience with dataintegrity requirements (21 CFR Part 11, Annex 11, etc.) Experience withpharmacopeia requirements (e.g. USP, JP, EP, etc.) Experience in QCcGMP laboratory environment (analytical or microbiology) knowledge of cGxPand regulatory requirements for clinical and commercial DP/DS Strong expertise inQuality Control, including proficiency in analytical techniquesand ensuring product quality Proven experience inQuality Assurance Proficiency inQuality Management and oversight of quality-related processes Excellentanalytical, organizational, and communication skills Excellent attentionto detail, leadership skills, and practical problem-solving abilities Ability to beflexible with changing priorities Preferred Experience inanalytical method transfer within a cGMP environment Knowledge ofaseptic DP process Experience with leansix sigma/continuous improvement methodologies Relevantcertifications or training in quality management, GMP, or auditingare advantageous Contract position. This position does not qualify for relocation benefits. Biostrategenix LLC is an Equal Opportunity Employer and does not discriminate on the basis of race or ethnicity, religion, sex, national origin, age, veteran disability or genetic information or any other reason prohibited by law in employment. #J-18808-Ljbffr Biostrategenix LLC