New 
Senior Quality Assurance Associate
 Advanced Clinical | |
 United States, North Carolina, Raleigh | |
 Jan 28, 2025 | |
|
OVERVIEW
We are currently searching for a skilled professional to join a well-known client's team as a Senior Quality Assurance Associate in Raleigh, North Carolina. The Senior Quality Assurance Associate role will play a critical role for data management of commercial biologics executed by contract laboratories. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity. RESPONSIBILITIES 1. Data review, data management to support use of electronic systems such as Veeva Quality eDocs, Minitab. 2. Perform and support data trending, interpretation and statistical analysis of commercial release and stability studies, for assay controls or reference standards and invalid assay trending. 3. Monitoring release and stability data to ensure data integrity, regulatory compliance, product quality, and on-time completion. 4. Acting as the technical reviewer of data sets, quality records and lab investigations generated by contract test labs. 5. Authoring CoAs, technical reports, internal quality records in accordance with regulatory requirements. 6. Serving as the SME for product specific test methods for internal and external quality control. 7. Collaborating frequently with internal and external cross-functional groups to provide status updates, workflows, and timelines for routine testing activities. These groups include CMOs/contract test labs, manufacturing operations, quality, regulatory and program management. 8. Monitoring product specific reference standard programs in collaboration with the network Analytical/Quality experts to sustain routine testing activities. This includes driving efforts for reference standard qualification, annual re-qualification, and distribution to contract test labs. 9. Supporting analytical method validation and method transfer activities. Requirements EXPERIENCE * 3+ years of pharmaceutical/biotech working experience in a cGMP Quality Control, analytical development, analytical transfer, or validation department in an FDA-regulated industry. * Familiarity with data trending and monitoring controls. * Hands-on experience within a bioanalytical lab. Familiarity with equipment and test methods which may include HPLC, CE, PCR, ELISA, gel-based assays and other compendial assays used to test biopharmaceuticals. EDUCATION Associate degree (required); BS/BA in pertinent life sciences or closely related field (preferred) To be a best-fit your strengths must include: * Familiarity with Method Validation, Analytical Transfers, or laboratory investigation experience. * Thorough understanding of principles, practices, and standards for biopharmaceutical testing. * Well versed in ICH and regulatory requirements for quality as it relates to QC operations, Laboratory compliance, data integrity, and quality events. * Experience performing statistical analysis of data sets using software such as JMP or Minitab is a plus. * Proficient in Microsoft Office tools, Minitab, Veeva Quality systems. * Strong organization and communication skills and technical writing skills. * Must be self-directed, goal-oriented, and quality conscious. * High attention to detail with the ability to rapidly see the big picture and assess the impact of data and/or decisions. About Advanced Clinical Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com. Regarding your application Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately. | |