Deviation Investigator # 26-24606

Us Tech Solutions; Greenville (NC); On-site; USD 55,000 - 69,000; Full time

Job summary

US Tech Solutions is seeking a Quality Assurance Deviation Specialist in Greenville, NC. You will identify deviations from SOPs and regulatory guidelines, perform root-cause investigations, and help implement CAPAs in a cGMP environment.

Precise documentation and GDP compliance are essential as you collaborate with cross-functional teams. The contract role runs for 12+ months, with an hourly rate of $40-$50, depending on experience and qualifications.

Qualifications

• Deviations documented per SOPs and GDP guidelines.
• Strong analytical and problem-solving abilities.
• Knowledge of regulatory requirements and GMP/GLP basics.

Responsibilities

• Identify and document deviations from SOPs, quality standards, or regulatory guidelines.
• Conduct root-cause investigations to determine deviations’ sources.
• Collaborate with cross-functional teams to implement CAPAs.
• Maintain records of deviations, investigations, and CAPAs.

Skills

Deviation management

cGMP environment

Regulatory knowledge

Analytical skills

Technical writing

Microsoft Office

Communication skills

Education

Associate or bachelor’s degree in Life Sciences

Tools

Microsoft Office

Job description

$40-$50 per hour

Greenville, NC

Contract

Duration: 12+ months

Job Description:

• Identify and document deviations from standard operating procedures (SOPs), quality standards, or regulatory guidelines.
• Conduct thorough investigations to determine the root cause of deviations.
• Collaborate with cross-functional teams to develop and implement corrective and preventive actions (CAPAs).

Documentation and Reporting:

• Maintain accurate and detailed records of all deviations, investigations, and CAPAs.
• Prepare and present deviation reports to management and regulatory authorities as required.
• Ensure documentation is completed in accordance with Good Documentation Practices (GDP).

Compliance and Quality Assurance:

• Ensure all deviations are managed in compliance with company policies, industry standards, and regulatory requirements.
• Participate in internal and external audits and inspections, providing necessary documentation and information related to deviations.

Continuous Improvement:

• Analyze deviation trends and provide insights for continuous improvement initiatives.
• Participate in training programs to enhance knowledge and skills related to deviation management and quality assurance.

Qualifications:

• Regulated Industry, cGMP environment experience, deviation management, or a e.g., Pharmaceuticals, Manufacturing, Engineering, Medical, Law Enforcement, etc.].
• Strong Attention to details, technical writing, Analytical and problem-solving skills.
• Knowledge of regulatory requirements and standards.
• Intermediate to Advanced skills in Microsoft Suite (Word, Excel, PowerPoint)
• Excellent communication and interpersonal skills.

Preferred Qualifications:

• Associate or bachelor’s degree in a relevant field such as Life Sciences, Engineering, Medial, or Quality Management with 2+ years of related experience.
• Preferred Experience: Biologics, Aseptic, Filling Isolators, Six Sigma Certification, Electronic documentation systems.
• Familiarity with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com .

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

AI Statement:

By applying, you acknowledge that AI-assisted tools may be used during hiring.

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