QA Validation Engineering Specialist in Warren, NJ

Specialist, QA Engineering

Onsite role, Warren NJ

Work Schedule: Monday - Friday, Business Hours 

Purpose and scope of position:

• The Specialist, QA Engineering is responsible for ensuring quality, integrity, and compliance of site Information Technology (IT) systems, review of 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.

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 for life sciences company regulated by the FDA is preferred.
• Advanced level experience in 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 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, 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.
• Drive strong collaboration within the site and across the network.

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, setup and function in a GMP-compliant manner to safeguard and maintain the safety and quality of 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, assist 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 the change initiatives and the implementation of process improvement initiatives.
• Ensure 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

 Education And Experience (As Applicable)

• B.S. degree required.
• 8 + years of experience in the pharmaceutical or related industry required
• Equivalent combination of education and experience acceptable.

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.

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