Our client is seeking a Quality Assurance Manager to support and provide subject matter expertise 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; provide oversight of GMP systems completed by CMOs and External Supply Chain function; Review and evaluate CAPA for effectiveness; review and mitigate risks and provide overall QA support to the assigned business function.
Skills and Qualifications
Â· Education: BS / BA
Â· Must have experience/knowledge of drug substance/product/finished product manufacturing processes in a cGMP environment
Â· Must have experience with medical devices.
Â· Must have knowledge of industry best practice and current regulatory expectations concerning drug substance, drug product and finished product manufacturing.
Â· Minimum of 5 years GMP related experience in biopharmaceutical / pharmaceutical or related industry
Â· Experience working with contract manufacturing organizations (CMO)
Â· Ability to provide project leadership and guide successful completion of Quality projects
Â· Experience in reviewing Corrective and Preventive Actions (CAPA); which includes tracking, follow-up, and reporting/trending and evaluating CAPA for effectiveness
Â· Excellent written and verbal communication and negotiating skills
Â· Risk assessment and risk management
Â· Ability to exercise judgment with defined procedures and practices to determine appropriate action
Â· Ability to prioritize daily activities in order to meet internal and external customer needs on time of established timelines in a fast-paced environment
Â· Ability to monitor and report on assigned tasks, goals, and objectives.
Job Type: W-2 contract
Duration: 6 months
Location: New Haven, CT â€“ must be onsite 40 hrs./week