Senior Quality Assurance Specialist
About The Position
Interpret external regulatory standards and expectations into appropriate quality standards and provide mentorship to project teams or functions to ensure overall compliance with AstraZeneca and Regulatory requirements are met. Provide QA input into internal manufacturing activities for Drug Substance and Drug Product, including issuance of batch documentation and labels for GMP manufacture/packaging, support of on-the-floor manufacturing activities, and support of manufacturing and packaging deviations and investigations. Lead continuous and quality improvement efforts in line with GMP regulations via tracking and trending of site metrics. Support activities associated with QA release of Drug Substance, Drug Product, and Investigational Medicinal Product for clinical trials, including quality review of release documentation for completeness and compliance with cGMPs as per regulatory requirements and internal procedures. Assist during Internal/External Inspections. Lead projects related to compliance of the quality system, development of new procedures and controls, and maintenance of established programs. Author or provide quality mentorship in the handling of nonconformance and CAPAs related to the medical device quality systems. Provide quality and technical support for the evaluation of change assessments for combination products and the device quality system. Collaborate with suppliers and/or internal interested parties to address development, risk management, change control, quality, or auditing activities. Work cross-functionally to implement product quality requirements and quality standards into compose inputs, to develop product specifications, and to conduct build verification and validation activities. Support risk management (e.g. FMEA) and quality planning activities. Support/ build control gap assessments, remediation planning, and remediation execution as the need arises.
Requirements
- Bachelor’s Degree, preferably in Life Sciences
- Minimum of five (5) years of experience working in the pharmaceutical and/or biotechnology field with a focus on GMP studies
- Demonstrated knowledge of Quality Assurance activities, ICH regulations, and FDA/EU GxP regulations as they relate to clinical trials, product development, manufacturing, and technology transfer
- Outstanding interpersonal, problem solving, and written/verbal proficiency
Nice To Haves
- At least three (3) years of experience in Quality Assurance
- Excellent team working and networking skills to encourage team efficiency
- Ability to lead and encourage colleagues
- Demonstrates independent judgement and uses risk management in intricate situations
- Capable of making decisions, acting fearlessly, and presenting with conviction and inspiration
- A good communicator with experience interacting optimally across interfaces collaborating internally
- Builds excellent relationships both internally and with external suppliers or service providers
Responsibilities
- Interpret external regulatory standards and expectations into appropriate quality standards
- Provide mentorship to project teams or functions to ensure overall compliance with AstraZeneca and Regulatory requirements
- Provide QA input into internal manufacturing activities for Drug Substance and Drug Product
- Lead continuous and quality improvement efforts in line with GMP regulations via tracking and trending of site metrics
- Support activities associated with QA release of Drug Substance, Drug Product, and Investigational Medicinal Product for clinical trials
- Assist during Internal/External Inspections
- Lead projects related to compliance of the quality system, development of new procedures and controls, and maintenance of established programs
- Author or provide quality mentorship in the handling of nonconformance and CAPAs related to the medical device quality systems
- Provide quality and technical support for the evaluation of change assessments for combination products and the device quality system
- Collaborate with suppliers and/or internal interested parties to address development, risk management, change control, quality, or auditing activities
- Work cross-functionally to implement product quality requirements and quality standards into compose inputs, to develop product specifications, and to conduct build verification and validation activities
- Support risk management (e.g. FMEA) and quality planning activities
- Support/ build control gap assessments, remediation planning, and remediation execution as the need arises
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
