What are the responsibilities and job description for the Deviation Investigator position at VARITE INC?
VARITE is looking for qualified Deviation Investigator in Greenville, NC.
WHAT THE CLIENT DOES?
An American-headquartered life science and clinical research company. It is a global supplier of analytical instruments, clinical development solutions, specialty diagnostics, laboratory, pharmaceutical and biotechnology services.
WHAT WE DO?
Established in the Year 2000, VARITE is an award-winning minority business enterprise providing global consulting & staffing services to Fortune 1000 companies and government agencies. With 850 global consultants, VARITE is committed to delivering excellence to its customers by leveraging its global experience and expertise in providing comprehensive scientific, engineering, technical, and non-technical staff augmentation and talent acquisition services.
Job Title: Deviation Investigator
Location: Greenville, NC
Contract Duration: 9 months
Pay Rate Range: $40.00 - $50.00/hr. on W2
Work Authorization: Only USC or GC
HERE’S WHAT YOU’LL DO
Description:
How will you make an impact?
- A leading pharmaceutical organization is seeking a Deviation Specialist to support its quality and compliance operations within a high-volume sterile manufacturing facility.
- This role focuses on conducting thorough investigations, driving root cause analysis, and contributing to continuous improvement initiatives in a regulated environment.
- This role ensures that all deviations are managed in compliance with company policies and industry regulations, and that corrective and preventive actions (CAPAs) are implemented effectively.
- The ideal candidate will be a skilled technical writer with strong communication and problem-solving abilities, and a comfort level in navigating complex production environments.
Key Responsibilities:
- Deviation Management:
- 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.
- Associate or bachelor’s degree in a relevant field such as Life Sciences, Engineering, Medial, or Quality Management.
- Preferred Experience: Biologics, Aseptic, Filling Isolators, Six Sigma Certification, Electronic documentation systems.
- Familiarity with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
Working Conditions:
- This job operates in a professional office environment as well as the Production, Laboratory, and Warehouse environment in a pharmaceutical facility.
- While performing the duties of this role, the employee is required to walk, sit, and use hands to handle or feel tools or controls, reach with hands and arms, balance, stoop, crouch, bend, talk, and hear. The work is typically located in a comfortable indoor area. There may be regular exposure to mild physical discomfort from factors such as temperature extremes, loud noise, strong drafts, or bright lights.
BENEFITS:
We offer a comprehensive benefits package designed to support the health, well-being, and financial security of our employees and their families. Eligible employees may receive:
- Health Insurance: Medical, dental, and vision coverage
- Retirement Plans: Participation in a company-sponsored retirement savings plan.
- Legal Service Plans: Offering access to attorneys for legal advice and representation.
If this opportunity interests you, please respond by clicking on EasyApply.
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VARITE is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
Salary : $40 - $50