Location: Boston, MA
external QC testing activities, including in-process control, release, stability, and/or method transfer and method validations;2. Review analytical data integrity of external labs data. Perform QC review of testing records for Drug Substance (DS) and Drug Product (DP) good manufacturing practices (GMP) release and stability testing to verify the analytical data generated at the CDMO laboratory is accurate, in compliance with c GMP regulations, and meets specifications; and that validated/approved analytical methods and procedures are followed;3.
Review batch release Co As and stability reports generated by external quality control/R&D labs to ensure the accuracy and quality of chemical
data. Document batch analyses, stability testing results, and Co As/reports in our quality system. Compile batch analysis histories and stability testing results to assist with trend analysis;4.
Responsible for stability programs at CDMO to support retest period or shelf life of clinical trial materials and regulatory filings; 5. Conduct product quality-related investigations, analytical/quality control lab OOS/OOT, and deviation investigations to identify proper Corrective and Preventative Actions (CAPAs) and monitor CAPA effectiveness checks;6. Provide QC support for method validation activities and ensure new and existing analytical methodologies are appropriately implemented and/or
developed for use at CDMOs in collaboration with analytical development team;7.
Track inventory of analytical reference standard materials, expiry date, and standard qualification status;8. Conduct QC review of regulatory submission documents, authoring stability, and related sections to support regulatory filings. May telecommute part of the week from commuting distance to Boston, MA in accordance with the companys flexible working policy. Minimum Requirements: A Bachelors degree or foreign equivalent in Chemistry, Biochemistry, or a closely related field, followed by 8 years of post-baccalaureate experience in a medical industry analytical or quality control-related occupation.
Experience must include the following, which may have been gained concurrently: 1) 8 years of analytical or Quality Control experience using analytical techniques, including HPLC, GC, KF, UV, IR, and Dissolution;2) 8 years of experience with solid dose drug product characterization and dissolution testing for novel drug development;3) 8 years of experience with the timely generation of high-quality data in compliance with Good Manufacturing Practices (GMP) and in compliance with ICH and regulatory requirements;4) 8 years of experience working on method development and method validation/transfer/verification for small molecule drug substance and drug product development, including reviewing and writing relevant analytical protocols/reports;5) 8 years of experience supporting regulatory submissions, including IND, IMPD, CTA, NDA, and ANDA;6) 5 years of experience with responsibility for stability study programs;7) 5 years of experience reviewing QC data to support In-process control, Drug Substance/Drug Product release, and stability testing, as well as performing quality-related investigations, OOS/OOT, and deviation to identify proper CAPAs;8) 5 years of experience with reference standard inventory, qualification testing, and certificate of analysis.
Job site: 225 Franklin Street, Suite 2100, Boston, MA 02110. Full-time. JOB OPPORTUNITY QUALIFIES FOR EMPLOYEE INCENTIVE REFERRAL PROGRAM. To learn more & to apply, click the " Apply Online" button.
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Quality Assurance (QA) jobs involve ensuring that products, services, or processes meet established standards of quality through systematic activities and measures. These roles typically focus on preventing defects, identifying potential issues, and implementing solutions to maintain quality consistency. Key features of QA positions include rigorous testing, meticulous attention to detail, and a commitment to continuous improvement. QA professionals work across various industries, from software development to manufacturing, to safeguard customer satisfaction and comply with regulatory requirements.
Quality Assurance (QA) jobs involve ensuring that products or services meet specific standards and satisfy customer expectations. Professionals in this field focus on systematic processes and preventative measures during production or development to prevent mistakes and defects. QA roles typically require keen attention to detail, problem-solving skills, and knowledge of industry standards. They may encompass various tasks, such as developing quality assurance plans, conducting tests, and analyzing data to improve quality and reliability. QA jobs contribute significantly to a company's reputation by guaranteeing product consistency and safety.
