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

Functional responsibilities for the incumbent include facilitating Change Control Review Board (CCRB) and record tracking meetings (e.g. Change Actions weekly) as applicable, driving proactive and corrective improvements within Operations, providing support at all regulatory inspections and corporate audits, tracking internal/external audit commitments and driving on time closure, evaluation of new requirements and emerging regulations, providing user support for the different Quality Systems as a site lead which includes integration activities and generation and review of Site Quality Metrics. Duties/Responsibilities : Ensure control of systems, processes and products through facilitation of CCRB. Represent site and provide impact assessment for global changes at Global CCRB Monitor and track external audit/inspection commitments to ensure timely closure. Track site change controls and ensure appropriate requirements are identified and completed for implementation. Provide weekly change control due date updates to the Tier board metrices. Must be skilled in planning and organizing, decision-making, and building relationships. Familiar with Veeva Vault QMS system. Able to effectively multi-task. Reporting Relationship Reports to Senior Manager, QA Engineering

Skills & Requirements

REQUIRED COMPETENCIES

B.S. degree required, minimum of five years of experience in the pharmaceutical or related industry. Experience with cGMP manufacturing, Quality, and compliance. Excellent verbal and written communication skills. Thorough knowledge of and competence in quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.

Must have advanced knowledge and experience with cGMP manufacturing, Quality, and compliance. Directs quality initiatives that accomplish continuous improvement and enhance site manufacturing efficiencies, while providing a safe and compliant process. Must be able to effectively prepare communications with interpretation of data analysis and potential problems to management and the group with clarity and a high level of accuracy. Must be able to note technical/scientific attributes in potential situations or issues and process science-based solutions across a majority of the job function. Must provide guidance to other employees in the interpretation of technical/scientific issues across a majority of the job function and manage development of technical or scientific initiatives and activities by interdisciplinary teams. Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking. Must possess an independent mindset and tenacity. Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision. Work is self-directed. Confident in making decisions for minor issues. Routinely recognizes Quality issues and solves problems. Proposes solutions for complex issues and works with management to resolve. Follows established procedures and performs work as assigned. Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution. Is recognized Subject Matter Expert within the group. Provides guidance to other employees in interpretation of complex data. Capable of providing input within the department and cross functional teams. Build relationships internally within and with cross functional teams. Contributes to goals within the work group. Able to recognize conflict and notify management with proposed recommendations for resolution. Able to prepare written communications and communicate problems to management with clarity and accuracy. Able to write and review reports with clarity and brevity. Able to effectively multi-task and execute project management skills. Knowledge of US and global cGMP requirements. Understanding of aseptic manufacturing processes. Teamwork and ability to work effectively across functional groups and teams to ensure requirements are met. Ability to make independent and objective decisions and to work with minimal supervision.

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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