The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate’s/applicant’s qualifications, skills, and level of experience as well as the geographical location of the position.

Applicants must be legally authorized to work in the United States. Sponsorship not available.

Our client is seeking a Specialist, QA Engineering in Warren NJ.

Role Description

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.

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 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 4.

Skills & Requirements

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.

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.

Benefits/Other Compensation

This position is a contract/temporary role where Hays offers you the opportunity to enroll in full medical benefits, dental benefits, vision benefits, 401K and Life Insurance ($20,000 benefit).

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there’s a position you really want, you’re fully prepared to get it.

Nervous about an upcoming interview? Unsure how to write a new resume?

Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.

Hays is committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences. We believe that the more inclusive we are, the better we serve our candidates, clients, and employees. We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law. One of Hays’ guiding principles is ‘do the right thing’.
We also believe that actions speak louder than words.
In that regard, we train our staff on ensuring inclusivity throughout the entire recruitment process and counsel our clients on these principles. If you have any questions about Hays or any of our processes, please contact us.

In accordance with applicable federal, state, and local law protecting qualified individuals with known disabilities, Hays will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570.

Drug testing may be required; please contact a recruiter for more information.

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