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Quality Assurance Auditor
Merial
North Brunswick, NJ
Please apply online at
www.merial.com , our
application process is quick & easy to complete.
Merial is a world-leading, innovation-driven animal health company,
providing a comprehensive range of products to enhance the health,
well-being and performance of a wide range of animals. Merial employs
approximately 5,000 people and operates in more than 150 countries
worldwide. Its 2006 sales were nearly $2.2 billion. Merial Limited is a
joint venture between Merck & Co., Inc. and sanofi-aventis. For more
information, please see www.merial.com.
Reporting to the Senior Manager, the QA Auditor provides support to new
product registrations in Merial. Implements procedures to ensure the
integrity of all Merial research output intended for regulatory
submission. The incumbent provides regulatory and quality guidance to
research personnel. The incumbent works autonomously to resolve quality
issues and audit findings.
Responsibilities include:
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Audit
assigned efficacy, safety, validation and material release data and
reports for compliance with US and EU regulatory directives (i.e., FDA,
EPA, and OECD) |
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Ensure
that studies are conducted and the data collected in compliance with
appropriate guidelines, protocol, Standard Operating Procedures and/or
other governing factors |
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Assist
in conducting audits of R&D departments for compliance with regulatory
directives and corporate, divisional and departmental policies and
procedures |
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Issue
timely and accurate audit reports that communicate what was audited and
any observations or non-compliance issues observed |
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Identify opportunities for quality improvements and assist in gaining
approval for and implementing quality improvements |
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Provide
timely and accurate reporting of appropriate measures of quality
performance |
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Review
R&D departmental SOPs for compliance with regulatory directives and
Merial quality standards |
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Conduct
audits and inspections of Merial and contract facilities to ensure
adherence to Merial quality requirement. |
Qualifications include:
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BA/BS
Degree (Life Sciences preferred) |
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Minimum
of two years experience conducting audits in the pharmaceutical,
biological or equivalent industry is required |
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Knowledge of EPA, FDA and/or OECD regulations and guidelines is required
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Strong
oral and written communication skills and interpersonal skills are
required |
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Ability
to work in a project team environment |
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Fluency
with MS Word and Excel software is recommended |
Please
apply online at
www.merial.com , our application process is quick & easy to
complete. |