Quality Specialist - II; Associate

Position: Quality Specialist - II (Associate)
Description:

SCOPE MEASURES

• This position is key to the completion of final study reports for GCP and GLP studies required for submission to CVM, EPA, and international regulatory agencies. A thorough and expeditious audit process is necessary for meeting high-quality submission requirements.

• This position is required in assuring MAH research meets or exceeds all relevant government and company compliance regulations and standards.

BACKGROUND REQUIREMENTS

• Bachelor's degree with 5 years related experience, with at least 2 years auditing experience in the regulatory compliance environment,

• Must have strong communication, organization and writing skills.

• Knowledge of VICH GCP Guidelines, FDA, EPA and OECD GLPs.

• Ability to perform in a multi-task environment; ability to facilitate and/or lead a variety of meeting formats.

Note:

• Hybrid 3 days onsite - (Tuesday and weds onsite core days, choice of Monday or Thursday for third onsite day)

•

Work Location:

Rahway,NJ

SUMMARY OF POSITION
This position will provide Quality Assurance oversight to Intervet Inc d/b/a client Animal Health (MAH) Global Research and Development Department. It will satisfy the requirements for a Quality Assurance Unit (QAU) according to the Good Clinical Practice VICH GL9 Guidance Document, FDA 21 CFR Part 58.35 and EPA 40 CFR Part 160.35 Good Laboratory Practices.

• The primary focus of this position is to assure that planned and systematic processes are established to ensure that study and data are collected, documented and reported in compliance with the applicable regulations, guidance documents, other applicable regulatory requirements, study protocols, SOPs, and industry standards.

• This position may develop and provide training on regulatory compliance issues internally or to the business partners of client Animal Health who work in a regulated environment.

• This position will review, revise, and develop SOPs that are necessary to govern the function of the R&D QA Department.

• This position will assist the management of Global R&D Quality Assurance or designee in handling government or corporate inspections.

MAJOR ACTIVITIES AND RESPONSIBILITIES
Major activities and responsibilities include:

• Plan and conduct study, Internal and external facility inspections, as well as data and report audits to ensure compliance with SOPs, government regulations and guidelines. Requires extensive interaction with study monitors, program managers, study directors and management, as appropriate.

• Issues audit reports to the study monitor, study director, investigator and study management as appropriate. Tracks audit reports. Reviews audit responses to ensure appropriate actions and documentation has occurred. Distributes audits to management.

• Review animal health bioanalytical studies conducted in-house. Be familiar with auditing GLP data in Analyst and Watson LIMS systems.

• Working knowledge of FDA Guidance for Industry, Bioanalytical Method Validation (LC/MS-MS preferred).

• Performs facility inspections and audits of contract research organizations that are utilized for GCP and GLP studies or study support. Issues audit reports to MAH management and contractors and ensure resolution to observations.

• Provide assistance to the management of Global R&D QA or designee in FDA, EPA and Corporate inspections of MAH facilities.

• Provides GCP workload status reports to management and provides GCP/GLP training to MAH personnel as appropriate.

• Review, revise and develop SOPs which govern the function of the Global R&D QA department. Review other Global R & D department SOPs as appropriate.

• Performs internal facility audits of MAH research facilities.

• Reviews and provides feedback on protocols and protocol amendments for compliance with SOPs, government regulations and guidelines and for internal consistency.

• Conduct GLP training for Global R & D departments.