Come join our team where we are innovators, leaders, and collaborators. And at the heart of everything we do is an intense desire to pursue the toughest challenges and truly change the world for people living with rare and devastating diseases.We are incredibly proud that our work has been recognized globally through some of the industry's highest honor.
location: New Haven, Connecticut
job type: Contract
salary: $48.00 - 50.20 per hour
work hours: 8am to 5pm
responsibilities: Position Summary
The Sr. Specialist 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 CAPA's. Sr. QA Specialist performs all responsibilities in accordance with company policies, procedures, and regulations. Principal Responsibilities
- Serve as Quality Assurance support and SME for Drug Substance, Drug Product, Devices 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 Product.
- 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 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
- Approve Alexion specific standard operating procedures and controlled documents issued by contract manufacturing organisations
- Support contract manufacturing organisation 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 needed
- 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 practice 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.
- Bachelor's degree required; preference given to candidates with advanced degrees; Two or more years of cGMP experience preferred; consideration will be given to other relevant experience and education.
- Experience level: Experienced
- Minimum 6 years of experience
- Education: Bachelors (required)
- Quality Assurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.