Job Title: Specialist, QA Engineering

Location: Warren, NJ

Hours/Schedule: Mon- Fri Business hours

Type: Contract

Overview

Leading pharmaceutical company looking for an experience QA Engineering Specialist. Ideal candidates should have a BS degree and 8+ years of experience in a pharmaceutical or related industry.

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 BMS’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

  Requirements

• B.S. degree required.

• 8 + years of experience in the pharmaceutical or related industry required

• Equivalent combination of education and experience acceptable.

  Benefits

  System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.