Job Description

Manufacturing Investigator

The Deviation Investigator is tasked with identifying, documenting, investigating, and resolving deviations from standard procedures, protocols, or regulatory requirements. This role is pivotal in ensuring that all deviations are managed in compliance with company policies and industry regulations, and that corrective and preventive actions (CAPAs) are implemented effectively.

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

Essential Skills

• At least 2 years of experience in a pharmaceutical environment conducting investigations.
• Strong analytical and problem-solving skills, with proficiency in root cause analysis using methods such as fishbone and 5 whys.
• Proven experience in technical writing, particularly in writing investigations.

Additional Skills & Qualifications

• Knowledge of Good Manufacturing Practices (GMP).
• Experience in process improvement.

Work Environment

The role operates within a typical office environment, with working hours from Monday to Friday, 8:00 am to 5:00 pm. The hiring manager offers flexibility in the schedule. Expectation of 10 hours per week of overtime. Interviews will be conducted face-to-face. Manufacturing

Pay and Benefits

The pay range for this position is $50.00 - $50.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Greenville, NC.

Application Deadline

This position is anticipated to close on Sep 30, 2025.

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