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R&D Associate, ECC/Quality & Compliance Auditor

Position:

 

R&D Associate

 

Local title: Quality & Compliance Auditor

Reporting To:

 

R&D Manager, Quality & Compliance

Position Summary:

 

Monitor the Montvale site for compliance to the RB Quality Standards and US EPA Good Laboratory Practice Standards

Job Location:

 

Montvale, NJ

Responsibilities:

 

Quality & Compliance Auditor 

 

Support the site Quality Management System
•    Conduct internal audits and issue audit reports.
•    Review audit findings with the quality teams and laboratory representatives.
•    Ensure the Deviation/CAPA procedure is implemented in response to audit findings.
•    Monitor remediation and preventative action plans.
•    Monitor and report monthly metrics for the Change Management system.
•    Monitor site compliance to Good Documentation Practice requirements.
•    Assist in the review and revision of site Standard Operating Procedures.

 

Support the site Good Laboratory Practice program.
•    Maintain and update the facility study master schedule.
•    Inspect studies at appropriate intervals. Ensure compliance with protocol and good laboratory practice regulation.
•    Document observed deviations from protocols, standard operating procedures, and the good laboratory practice regulation.
•    Recommend appropriate corrective action for observed deviations and violations to ensure compliance.
•    Track laboratory response to each documented deviation.  Evaluate the response to ensure completeness and compliance.
•    Issue study finding reports that include each observed finding, recommended corrective action, and laboratory response. 
•    Review relevant standard operating procedures as they pertain to individual study compliance.
•    Conduct internal facility audits of the Microbiology and Analytical laboratories to ensure compliance with the US EPA Good Laboratory Practice Regulation.
•    Provide laboratory notebook training to formulators to ensure GLP compliance.
•    Audit GLP study reports issued by contract laboratories. Provide audit reports including recommended corrective and preventative actions.

 

Assist in the performance of the roles and responsibilities of the GLP Archivist as defined in the US EPA Good Laboratory Practice Regulation.  Maintain the archive in an inspection ready state.
•    Assure product retention samples have been submitted based upon the studies documented in the master schedule database.
•    Maintain product archives and chain-of-custody documents for retention samples.
•    Archive completed studies and facility records.
•    Maintain archive index and associated archive logs.  Perform monthly archive log reviews.
•    Monitor archive conditions.

Education and Experience Required:

 

•    Undergraduate degree required; BA/BS in the natural sciences preferred.
•    3-5 years Quality Assurance Auditing experience within ISO 9001, GMP, or GLP quality systems

Position Profile:


•    Sound knowledge quality management system requirements.
•    Excellent communication skills.
•    Ability to establish close communications and partnering with internal customers to ensure business objectives are understood and compliance to RB quality standards are achieved.
•    Ability to work with uncertainties and effect innovative solutions to complex regulatory and quality compliance requirements.
•    Proven experience in working within multi-functional and multi-cultural project teams.

Personal Skills:

 

•    Intermediate level proficiency in MS Excel, Power Point and Word.
•    Results-oriented, entrepreneurial, and self-motivating.
•    Bias for action, capacity to define, evaluate and take risks.
•    Strong negotiating, influencing and interpersonal skills.
•    Ability to understand of corporate and operational business issues.
•    Strong understanding of consumer issues.
•    Strong deductive reasoning skills.
•    Openness to change and ability to think out of the box.

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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