Quality Assurance Specialist III

Company: Mindlance
Location: New Haven
Posted on: June 25, 2022

Job Description:

Job DescriptionJob Description: QA Specialist III for QA External Manufacturing will be responsible for providing oversight of quality activities associated with drug substance, drug product, devices and finished product manufacturing processes at contract manufacturing organizations The Sr. Specialist contributes and supports the completion of milestones associated with specific projects and supports ongoing quality assurance responsibilities in support of: Contract Manufacturing oversight and quality systems including Change Control, Deviations and CAPAs. Sr. QA Specialist/Manager performs all responsibilities in accordance with company policies, procedures, and regulationsPrincipal Responsibilities Serve as Quality Assurance support and SME for Drug Substance, Drug Product, and Finished product manufacturing maintaining knowledge of industry standards and regulatory requirements to ensure all drug manufacturing, storage and shipping activities are compliant Providing oversight of GMP systems completed by CMO's and External Supply Chain function related to Drug Substance, Drug products, Devices, and Finished Products. Provides oversight to continuous quality system improvements and supports implementing improvements at CMOs in compliance, Preventive Maintenance, Deviation Management and Change Control Programs as they impact client Works closely to build relationships with contract manufacturers' quality personnel Works closely with internal cross-functional impacted areas, such as Global Clinical Supply, External Plant Operations, CMO Management, CMC/Regulatory Affairs, and Technical Services to resolve open issues in a timely manner resulting from record reviews and deviation events Responsible for reviewing contractor documents i.e. protocols, batch records, deviations and change controls to ensure that they comply with client procedures and meet client standards Responsible for Product release activities. Approve client-specific standard operating procedures and controlled documents issued by contract manufacturing organizations Support contract manufacturing organization audits, including pre-approval inspections Develop and issue quality metrics pertaining to the process quality activities Trends and analyses quality aspects of technical transfer activities to measure key performance indicators, identifies areas for continuous process improvements and risk mitigation, compiles and presents analyses at Quarterly Management Review meetings, proposes and leads team implementation of appropriate CAPA Reviews and assesses deviations; includes performing risk assessments, participating in root cause analysis investigations, tracking, follow-up, and reporting/trending Review Corrective and Preventive Actions (CAPA); includes tracking, follow-up, and reporting/trending and evaluating CAPA for effectiveness Supports Quality Assurance to guide various projects and technical meetings, as neededQualifications Must have experience/knowledge of drug substance/product/finished product manufacturing processes in a cGMP environment Must have experience with medical devices. Must have knowledge of industry best practices and current regulatory expectations concerning drug substance, drug product, and finished product manufacturing Minimum of 5 years GMP related experience in biopharmaceutical/pharmaceutical or related industry Experience working with contract manufacturing organizations Ability to provide project leadership and guide successful completion of Quality projects Excellent written and verbal communication and negotiating skills Risk assessment and risk management Ability to exercise judgment with defined procedures and practices to determine appropriate action Ability to prioritize daily activities in order to meet internal and external customer needs on time of established timelines in a fast-paced environment Ability to monitor and report on assigned tasks, goals, and objectives.Education: Bachelor's degree required; preference is given to candidates with advanced degrees; Two or more years of cGMP experience preferred; consideration will be given to other relevant experience and education

Keywords: Mindlance, New Haven , Quality Assurance Specialist III, Other , New Haven, Connecticut