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Deviation Management Specialist

L5

genesis10Greenville, NC32 days ago

$50.00 per hour

Occupations

Quality Control Systems ManagersRegulatory Affairs SpecialistsRegulatory Affairs Managers

Industries

Other Scientific and Technical Consulting ServicesTemporary Help ServicesPharmaceutical Preparation Manufacturing
Aptask Global Workforce (AGW) is seeking a Deviation Management Specialist for a contract position with a Leading Life Sciences Company located in Greenville, NC. This is a 12+ month contract opportunity. This role is focused on identifying, documenting, and investigating deviations from standard operating procedures within a regulated cGMP environment. The ideal candidate will conduct root cause analysis and collaborate with cross-functional teams to implement corrective and preventive actions (CAPAs) to ensure compliance and drive continuous improvement.
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 CAPAsPrepare 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
  • Analyze deviation trends and provide insights for continuous improvement initiatives
Requirements:
  • Experience in a regulated industry and cGMP environment
  • 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, or Quality Management with 2+ years of related experience
  • Experience with Biologics, Aseptic, and Filling Isolators
  • Six Sigma Certification
  • Experience with electronic documentation systems
  • Familiarity with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP)
Pay range: upto $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 DentalVisionSick 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 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.
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Level

SeniorL5

Salary

$50.00 per hour

Location

Greenville, NC

Occupation

Quality Control Systems Managers

Industry

Other Scientific and Technical Consulting Services

Posted

32 days ago

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