GLP Auditor Position Available In Western Connecticut, Connecticut

Job Description:

Job Title:

GLP Auditor Location:

Ridgefield

CT 06877

Duration:

6

Months Summary:

To implement the clients Regulatory ComplianceProgram designed to assure the adherence of facilities, operations,studies, reports and practices to regulations (e.g.

FDA, EMEA, NRC,DEA USDA

) as well as to their Standard Operating Procedures (SOPs),clients policies, regulatory guidelines and good scientific anddocumentation practices. To inform clients Management of deviationsfrom the cGMP, GLP, other Regulations observed duringaudits/inspections, to recommend appropriate corrective action whennecessary and to verify that appropriate corrective actions havebeen implemented that adequately address any deviations reportedduring inspections. You will actively contribute to the discovery,development and delivery of our products to our patients andcustomers. Our global presence provides opportunity for allemployees to collaborate internationally, offering visibility andopportunity to directly contribute to the companies´ success. Werealize that our strength and competitive advantage lie with ourpeople. We support our employees in a number of ways to foster ahealthy working environment, meaningful work, diversity andinclusion, mobility, networking and work-life balance. Duties ℜsponsibilities: Review procedures for compliance to GxPrequirements and Company standards Conduct audits to support GLPstudies (e.g. protocol, amendment, study data, PrincipalInvestigator reports such as Toxicokinetic reports, etc.) Issueelectronic audit reports and perform follow-up actions Scan studyrecords to facilitate audit requests Monitor and update electronicsystem with new audit requests Update the GLP Master Schedule asneeded Conduct internal facility audits as needed Provide supportduring corporate audit and regulatory inspections as needed

Required Skills:

GLP Auditing or comparable experience Intermediateknowledge of relevant regulations and guidance Works independentlywith moderate guidance Excellent conflict resolution andnegotiation skills Good organization skills Good to excellentverbal and written communication skills Desired Skills, Experienceand Abilities Previous GLP Auditing Experience is preferredPrevious Toxicokinetic/Bioanalytical experience is preferred

Education:

Bachelor´s Degree or equivalent with 3 years of Pharmaexperience or equivalent

About Us:

SPECTRAFORCE

is one of thefastest-growing workforce solutions firms in the United States. Asa diversity-owned business, we place human connection at the heartof everything we do, building strong relationships with bothclients and candidates to fill roles successfully. Our teams inNorth and Central America and India serve more than 150 Fortuneclients globally, leveraging custom AI technology to provide directhire, executive search, nearshoring, offshoring, and projectstaffing solutions.

Benefits:

SPECTRAFORCE

offers ACA complianthealth benefits as well as dental, vision, accident, criticalillness, voluntary life, and hospital indemnity insurances toeligible employees. Additional benefits offered to eligibleemployees include commuter benefits, 401K plan with matching, and areferral bonus program.

SPECTRAFORCE

provides unpaid leave as wellas paid sick leave when required by law.

Equal OpportunityEmployer:

SPECTRAFORCE

is an equal opportunity employer and doesnot discriminate against any employee or applicant for employmentbecause of race, religion, color, sex, national origin, age, sexualorientation, gender identity, genetic information, disability orveteran status, or any other category protected by applicablefederal, state, or local laws. Please contact Human Resources atLOA@spectraforce.com if you require reasonable accommodation.

California Applicant Notice:

SPECTRAFORCE

is committed to complyingwith the California Privacy Rights Act (“CPRA”) effective January1, 2023; and all data privacy laws in the jurisdictions in which itrecruits and hires employees. A Notice to California Job ApplicantsRegarding the Collection of Personal Information can be located onour website. Applicants with disabilities may access this notice inan alternative format by contacting NAHR@spectraforce.com .

LACounty, CA Applicant Notice:

If you are selected for this positionwith SPECTRAFORCE, your offer is contingent upon the satisfactorycompletion of several requirements, including but not limited to, acriminal background check. We consider qualified applicants witharrest or conviction records for employment in accordance with alllocal ordinances and state laws, including the Los Angeles CountyFair Chance Ordinance for Employers (FCO) and the California FairChance Act (FCA). The background check assessment will considerwhether a criminal history could reasonably have a direct, adverseimpact on the job-related safety, security, trust, regulatorycompliance, or suitability for this role. Such findings may resultin withdrawal of a conditional job offer. At

SPECTRA FORCE

, we arecommitted to maintaining a workplace that ensures fair compensationand wage transparency in adherence with all applicable state andlocal laws. This position’s starting pay is: $35.89/hr.