Deviation Investigator

Shift: 1st shift, Monday-Friday 8-5
Duration: 12 Months
Pay range:  $40.00 - $50.00 Hourly
Onsite Job
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).
 
Employee Benefits:
At LanceSoft, full time regular employees who work a minimum of 30 hours a week or more are entitled to the following benefits:

• Four options of medical Insurance
• Dental and Vision Insurance
• 401k Contributions
• Critical Illness Insurance
• Voluntary Permanent Life Insurance
• Accident Insurance
• Other Employee Perks

About LanceSoft
LanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. We provide Global Workforce Solutions with a human touch.