GLP Auditor

Job Title: GLP Auditor

Location: Ridgefield CT 06877

Duration: 6 Months

Summary:

To implement the clients Regulatory Compliance Program 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 and documentation practices. To inform clients Management of deviations from the cGMP, GLP, other Regulations observed during audits/inspections, to recommend appropriate corrective action when necessary and to verify that appropriate corrective actions have been implemented that adequately address any deviations reported during inspections.

You will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance.

Duties & Responsibilities:

Review procedures for compliance to GxP requirements and Company standards

Conduct audits to support GLP studies (e.g. protocol, amendment, study data, Principal Investigator reports such as Toxicokinetic reports, etc.)

Issue electronic audit reports and perform follow-up actions

Scan study records to facilitate audit requests

Monitor and update electronic system with new audit requests

Update the GLP Master Schedule as needed

Conduct internal facility audits as needed

Provide support during corporate audit and regulatory inspections as needed

Required Skills:

GLP Auditing or comparable experience

Intermediate knowledge of relevant regulations and guidance

Works independently with moderate guidance

Excellent conflict resolution and negotiation skills

Good organization skills

Good to excellent verbal and written communication skills

Desired Skills, Experience and Abilities

Previous GLP Auditing Experience is preferred

Previous Toxicokinetic/Bioanalytical experience is preferred

Education:

Bachelor's Degree or equivalent with 3 years of Pharma experience or equivalent

About Us: SPECTRAFORCE is one of the fastest-growing workforce solutions firms in the United States. As a diversity-owned business, we place human connection at the heart of everything we do, building strong relationships with both clients and candidates to fill roles successfully. Our teams in North and Central America and India serve more than 150 Fortune clients globally, leveraging custom AI technology to provide direct hire, executive search, nearshoring, offshoring, and project staffing solutions.

Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.

Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at if you require reasonable accommodation.

California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act ("CPRA") effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting .

LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.

At SPECTRA FORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position's starting pay is: $35.89/hr.

Duties & Responsibilities:

Review procedures for compliance to GxP requirements and Company standards

Conduct audits to support GLP studies (e.g. protocol, amendment, study data, Principal Investigator reports such as Toxicokinetic reports, etc.)

Issue electronic audit reports and perform follow-up actions

Scan study records to facilitate audit requests

Monitor and update electronic system with new audit requests

Update the GLP Master Schedule as needed

Conduct internal facility audits as needed

Provide support during corporate audit and regulatory inspections as needed

Permanent