Quality Assurance Specialist III

Company: Planet Pharma
Location: New Haven
Posted on: June 23, 2022

Job Description:

Position Summary:Specialist III for QA External Manufacturing will be responsible for providing oversight of quality activities associated with drug substances, drug products, 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 CAPA's. Sr. QA Specialist/Manager performs all responsibilities in accordance with company policies, procedures, and regulations.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 Product, Devices, and Finished Products.
• Provides oversight to continuous quality system improvements and supports implementing improvements at CMO's in compliance, Preventive Maintenance, Deviation Management and Change Control Programs as they impact Alexion
• 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 Alexion procedures and meet Alexion standards
• Responsible for Product release activities.
• Approve Alexion 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 technology 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 environmentMust have knowledge of industry best practices and current regulatory expectations concerning drug substances, drug products, and finished product manufacturing.Experience working with contract manufacturing organizationsAbility to provide project leadership and guide successful completion of Quality projectsExcellent written and verbal communication and negotiating skillsRisk assessment and risk managementAbility to exercise judgment with defined procedures and practices to determine appropriate actionAbility to prioritize daily activities in order to meet internal and external customer needs on time of established timelines in a fast-paced environmentAbility 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: Planet Pharma, New Haven , Quality Assurance Specialist III, Other , New Haven, Connecticut