Sr Qa Engineer Pharma Onsite Warren

Sr. QA Engineer Pharma (Onsite - Warren, NJ)

We are seeking a Sr. QA Engineer for a global pharmaceutical company. This role will be responsible for ensuring quality, integrity, and compliance of site Information Technology (IT) systems, and review of validation and qualification documents for all equipment and facility activities.

This is a 40-hour per-week, 12-month contract (extensions possible), 100% onsite in Warren, NJ.

This is a W2 role as a Stage 4 Solutions employee. Health benefits and 401K are offered.

Responsibilities:

• Ensure 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 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.
• Ensure site is compliant with global and regulatory data governance and data integrity reqs.

Requirements:

• 8 + years of Quality Assurance experience in the pharmaceutical company
• Must have advanced knowledge and experience with GMP, Quality and compliance.
• Previous experience as a computer system validation/quality assurance for a life sciences company regulated by the FDA
• Advanced level experience in design of user requirement specifications, IQ/OQ/PQ protocols, user acceptance testing and other equipment/facility qualification documentation.
• Experience in asset management software (e.g. Blue Mountain RAM) and quality systems software (e.g. Veeva).
• 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.
• B.S. degree

Please submit your resume to our network at (please apply to the Sr. QA Engineer Pharma (Onsite-Warren, NJ) role).

Please feel free to forward this project opening to others who may be interested.

Stage 4 Solutions is an equal-opportunity employer. We celebrate diversity and are committed to providing employees with an inclusive environment that is free of discrimination and harassment. All employment decisions are based on the job requirements and candidates' qualifications, without regard to race, color, religion/belief, national origin, gender identity, age, disability, marital status, genetic information, or other applicable legally protected characteristics.

Compensation: $60.00/hr. - $64/hr.

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