Deviation Investigator

Deviation Investigator

Location: Greenville, NC

Pay Rate: $ 50.00/hour

Schedule: Monday–Friday, 8:00 AM–5:00 PM

Work Arrangement: Fully Onsite

Interview: In-person

Position Overview

We are seeking an experienced Deviation Investigator to support quality and compliance operations in a regulated manufacturing environment. This role will be responsible for investigating deviations from established procedures and quality standards, determining root causes, developing corrective and preventive actions, and ensuring accurate documentation in accordance with regulatory and company requirements.

The ideal candidate will have experience working in a cGMP or other regulated environment , strong analytical and technical writing skills, and the ability to collaborate effectively with cross-functional teams.

Key Responsibilities

Deviation Investigation

• Identify and document deviations from SOPs, quality standards, and regulatory requirements .

• Conduct thorough investigations to determine the root cause of deviations.

• Gather and analyze relevant data, documentation, and information during investigations.

• Collaborate with cross-functional teams to develop and implement effective Corrective and Preventive Actions (CAPAs) .

• Ensure investigations are completed accurately and within established timelines.

Documentation & Reporting

• Maintain accurate and detailed records of deviations, investigations, and CAPAs.

• Prepare clear and comprehensive deviation investigation reports.

• Present investigation findings and recommendations to management and regulatory authorities when required.

• Ensure all documentation complies with Good Documentation Practices (GDP) .

• Maintain appropriate supporting documentation and investigation records.

Compliance & Quality Assurance

• Ensure deviations are managed in accordance with company procedures, industry standards, and applicable regulatory requirements.

• Support quality assurance activities and compliance initiatives.

• Participate in internal and external audits and regulatory inspections .

• Provide requested documentation and information related to deviation investigations during audits and inspections.

• Maintain a strong understanding of quality systems and regulated manufacturing requirements.

Continuous Improvement

• Analyze deviation trends and identify recurring issues or opportunities for improvement.

• Provide data-driven insights to support continuous improvement initiatives.

• Participate in quality and compliance training programs.

• Stay current with applicable regulatory requirements, quality standards, and deviation management practices.

Required Qualifications

• Experience working in a regulated industry or cGMP environment .

• Experience with deviation management and investigation .

• Relevant industry experience may include:

• Pharmaceuticals

• Biologics

• Manufacturing

• Engineering

• Medical/Healthcare

• Quality Assurance

• Other regulated industries

• Strong attention to detail and organizational skills.

• Excellent technical writing and documentation abilities.

• Strong analytical and problem-solving skills.

• Knowledge of applicable regulatory requirements and quality standards.

• Intermediate to advanced proficiency with Microsoft Office Suite , including:

• Word

• Excel

• PowerPoint

• Excellent written and verbal communication skills.

• Ability to collaborate effectively with cross-functional teams.

Preferred Qualifications

• Associate or Bachelor's degree in a relevant field such as:

• Life Sciences

• Engineering

• Medical/Healthcare

• Quality Management

• Related scientific or technical discipline

• 2+ years of related professional experience .

• Experience in biologics manufacturing .

• Experience with aseptic processing .

• Experience working with filling isolators .

• Six Sigma certification .

• Experience with electronic documentation systems.

• Familiarity with Good Manufacturing Practices (GMP) .

• Familiarity with Good Laboratory Practices (GLP) .

Work Environment

• Fully onsite in Greenville, NC

• Monday–Friday, 8:00 AM–5:00 PM

• In-person interviews required

• Professional, regulated manufacturing/quality environment

Ideal Candidate

The ideal candidate is a detail-oriented quality professional with hands-on experience investigating deviations in a regulated environment. They should be comfortable analyzing technical information, identifying root causes, writing comprehensive investigation reports, and partnering with multiple departments to implement effective CAPAs and improve overall quality performance.

Pay Details: $50.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.adecco.com/en-us/candidate-privacy

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act

• Los Angeles City Fair Chance Ordinance

• Los Angeles County Fair Chance Ordinance for Employers

• San Francisco Fair Chance Ordinance

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.