Shift: Monday-Friday 8-5
Fully onsite
Key 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).
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).
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