Job Description

SUMMARY OF POSITION:

This position will provide Quality Assurance oversight to Intervet Inc. (d/b/ our Company's Animal Health) Global Research and Development Department. It will satisfy the requirements for a Quality Assurance Unit (QAU) according to the FDA 21 CFR Part 58 Good Laboratory Practice Regulations and the VICH GL9 Good Clinical Practice Guidance Document. The primary focus of this position is to assure that planned and systematic processes are established to ensure that a study and the data are collected, documented and reported are in compliance with the GLPs and GCPs or other applicable regulatory requirements, as well as study protocols, SOPs, and industry guidance and standards.

MAJOR ACTIVITIES AND RESPONSIBILITIES:

Major activities and responsibilities include:

• Review animal health pre-clinical and clinical study reports and data.

• 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.

• Assist in performing facility inspections of contract research organizations that are utilized for GCP and GLP studies or study support.

• Issues audit reports to our Company's Animal Health management and contractors and ensure resolution to observations.

• Assist in performing internal facility inspections of our Company's Animal Health research facilities.

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

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

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

• Must have strong communication, organization and writing skills. Ability to perform in a multi-task environment.

BACKGROUND REQUIREMENTS:

• Bachelor's degree with 3 years related experience, with at least 1 year of auditing experience in the regulatory compliance environment.

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 our Company's Animal Health research meets or exceeds all relevant government and company compliance regulations and standards.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.

Expected US salary range:

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R328997