Job Description

Location: Greenville, NC 27834

Duration: 12 months - Contract

Pay Rate: $40.00 $50.00/ hr w2

Shift: M-F 8-5

Key Responsibilities:

• 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).

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