The Specialist, QA Engineering is responsible for ensuring quality, integrity, and compliance of site Information Technology (IT) systems and reviewing validation and qualification documents for all equipment and facility activities. This position is a member of the Cell Therapy Development and Operations (CTDO) organization, which supplies autologous and allogeneic cell therapies for first-in-human and pivotal clinical trials.
2. Required Competencies: Knowledge, Skills, and Abilities
Must have advanced knowledge and experience with GMP, Quality, and compliance.
Previous experience as a computer system validation/quality assurance professional for a life sciences company regulated by the FDA is preferred.
Advanced level experience in the design of user requirement specifications, IQ/OQ/PQ protocols, user acceptance testing, and other equipment/facility qualification documentation.
Must be fluent in standard Microsoft Office software; experience in asset management software (e.g., Blue Mountain RAM) and quality systems software (e.g., Veeva).
Drives use of best practices during IT systems design, validation, and use.
Must be able to recognize and group technical/scientific attributes and drive science-based decisions in most technical areas.
Must manage the development of technical or scientific initiatives and activities by interdisciplinary teams.
Must be able to critically review investigations and reports, interpret results, and generate technical conclusions consistent with Quality risk management principles.
Intermediate knowledge of quality systems, including CAPA, change control, and document management systems.
Requires minimal direction to complete tasks, with the authority to make daily decisions that impact their team.
Negotiates solutions cross-functionally. Drives continuous improvement and improves efficiency and productivity within the group or project.
Consults management for advice on complex issues.
Able to prepare written communications and communicate problems to management with clarity and accuracy.
Drives strong collaboration within the site and across the network.
3. Duties and Responsibilities
Functional responsibilities include ensuring accurate and timely maintenance of validation and qualification documents for all equipment and facility activities; investigations and evaluation of change control.
Ensure IT systems are designed, set up, and function in a GMP-compliant manner to safeguard and maintain the safety and quality of our client's products.
Provides QA oversight on key software development life cycle (SDLC) processes such as problem, incident, change, release, and deviations.
Support the Qualification and Validation activities in relation to QC and manufacturing equipment and facility design.
Assures appropriateness of calibration/maintenance programs, validation plans, qualification protocols, associated reports, and procedures.
Support ECQ, Facilities, QC, and manufacturing equipment-related investigations in ensuring appropriate and thorough impact assessment, root cause analysis, and corrective/preventive actions are documented and implemented.
Ensures compliance with the site validation master plan and assists with facility start-up operations and product transfers, supporting the Qualification and Validation teams.
Work with Engineering/Facilities/ECQ management to ensure functional activities comply with global regulatory requirements.
Sponsor and support change initiatives and the implementation of process improvement initiatives.
Ensure the site is compliant with global and regulatory data governance and data integrity requirements.
Support any other goals and objectives of the site Quality Assurance organization, as needed.
4. Education and Experience (As Applicable)
Education: B.S. degree required.
Experience: 8+ years in the pharmaceutical or related industry required.
Alternative Qualifications: Equivalent combination of education and experience acceptable.
5. Working Conditions (US Only)
Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate, and there are no abnormal conditions caused by noise, dust, etc.
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will perform other job-related duties as requested by management.
6. Additional Information
Contingent Workers whose jobs involve the operation of a vehicle or machinery, or physical presence in a laboratory, research, drug development, or manufacturing facility, are prohibited from having any amount of alcohol or illicit drugs in their body while in the workplace or performing their job functions.
Suppliers and the Contingent Worker are responsible for ensuring they are fit for all the duties of the job.