Deviation Management Specialist

AGW - 4.3

Greenville, NC Job Details Contract Up to $50 an hour 1 day ago Benefits Health insurance Dental insurance Vision insurance Paid sick time Qualifications Microsoft Excel Technical writing experience within manufacturing Regulatory/legal compliance standards in production Productivity software Pharmaceutical manufacturing facility experience Full Job Description Aptask Global Workforce (AGW) is seeking a Deviation Management Specialist for a contract position with a Global Biotechnology Company located in Greenville, NC. This is a 12+ month contract opportunity. This role is focused on ensuring quality and compliance within a regulated cGMP environment. The ideal candidate will be responsible for identifying and investigating deviations from standard operating procedures, developing corrective and preventive actions (CAPAs), and maintaining meticulous documentation to support both internal quality standards and external regulatory requirements.

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 CAPAs Prepare and 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

Requirements:

Experience in a regulated industry and cGMP environment (e.g., Pharmaceuticals, Manufacturing, Engineering, Medical, Law Enforcement, etc.) Strong attention to detail, 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 Desired skills: Associate or bachelor's degree in a relevant field such as Life Sciences, Engineering, Medical, or Quality Management with 2+ years of related experience Experience with Biologics, Aseptic processes, or Filling Isolators Six Sigma Certification Experience with electronic documentation systems Familiarity with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) Pay range: up to $50.00 per hour Only candidates available and ready to work directly as Aptask Global Workforce (AGW) employees will be considered for this position. If you have the described qualifications and are interested in this exciting opportunity, apply today! Aptask Global Workforce (AGW) ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery. Benefits of working with ApTask Global Workforce include: Medical Dental Vision Sick Pay (for applicable states/municipalities) Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website https://www.agwtalent.com/. ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran. #INDAGW