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R&D Senior Associate, Quality & Compliance

Job Title:

Senior Quality Associate 

Department:

Quality & Compliance 

Location:

Montvale, NJ

 

We are looking for a highly conscientious and detail-oriented candidate for the role of Senior Quality Associate in our Quality & Compliance team. This role is responsible for the development of a quality culture within the site through training, implementation and monitoring of local and corporate quality standards.
 

Accountabilities/ Responsibilities

 

•    Ensure compliance with corporate and local Quality Management System (QMS) requirements.
•    Assist in the preparation and implementation of quality assurance policies and procedures.
•    Assist in the development of a training program for key quality processes.
•    Provide training and coaching to encourage a quality culture in the product development process.
•    Provide quality input and support for new product development projects.
•    Assist the quality team in the development of annual quality objectives and relevant key performing indicators. Trend and report quality performance metrics.
•    Conduct internal audits and issue audit reports.
•    Track corrective and preventative action plans.
•    Collaborate with R&D to resolve significant quality issues associated with product development activities.
•    Assure management that the Good Laboratory Practice Standard (GLP) program is maintained to RB and regulatory standards.
•    Conduct GLP compliance audits as scheduled at contract laboratories.
•    Assist in auditing individual contract laboratory studies and trend compliance issues.
•    Determine that no deviations from approved protocols or standard operating procedures were made without proper authorization and documentation
•    Review final study reports to assure the report accurately describes the methods and that the reported results accurately reflect the raw data of the study
•    Trend compliance issues. Using a risk-based approach and collaboration with the Regulatory department, determine which issues must be raised to contract laboratory management.
•    Work with contract laboratory Quality Assurance departments to resolve compliance issues.
•    Maintain inspection readiness status for both corporate audits and regulatory authority inspections.

Key Challenges:

 

•    Projects are subject to tight deadlines which must be met without compromising product safety, quality and efficacy, or compliance to regulatory standards.
•    Maintaining a .balanced compliance quality culture while delivering the business needs.
•    Maintaining awareness of broad activities of R&D, Marketing, Regulatory, and Supply; integrating quality systems and as required product regulatory compliance.
•    The job holder needs to maintain a strong working knowledge of the corporate QMS requirements.
 

Qualifications

 

•    Minimum - BS/BA degree in a related science discipline
•    At least ten years relevant quality assurance experience at an associate level
•    General understanding of the product development process from concept ideation to launch
•    Strong understanding of quality management system requirements and concepts especially ISO 9001
•    Project management skills
•    Excellent organizational and problem-solving skills
•    Strong interpersonal skills to nurture teamwork and foster an environment of achievement
•    Results-oriented and self-motivating
•    Ability to display a degree of flexibility and adapt effectively to change
•    Excellent communication skills, written and verbal
•    Proficient with common software, including MSOffice.
•    ASQ Quality Auditor certification a plus
•    Equipment/process validation experience a plus

Equality

In Return RB offer very competitive salaries with excellent benefits and the chance to progress your career within a truly global organisation.
RB is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other basis protected by appropriate law. All hiring decisions are made based on merit, competence and business need.


Nearest Major Market: New York City

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