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Field Quality Assurance Specialist
2 months ago
Crox Consulting Inc is seeking a highly skilled Field Quality Assurance Specialist to join our team in Devens, MA. As a key member of our quality assurance team, you will be responsible for conducting QA activities on the manufacturing floor, ensuring adherence to relevant procedures and batch records, and reviewing manufacturing batch records in real-time.
Key Responsibilities:- Conduct quality assurance activities on the manufacturing floor to ensure compliance with regulatory requirements and company standards.
- Review and verify batch records to ensure accuracy and completeness.
- Assess shop floor documentation for compliance with quality procedures and regulations.
- Identify and report quality issues to management and implement corrective actions.
- High School Diploma required; a relevant college degree is preferred.
- At least 4 years of experience in a Quality Assurance role is required.
- Equivalent combinations of education and experience will be considered.
- Must be proactive and skilled in decision-making, relationship-building, problem-solving, conflict resolution, planning, and analytical thinking.
- Familiarity with continuous improvement practices and enhancing efficiency.
- Ability to establish relationships within and across teams.
- Knowledge of FDA-regulated cGMP environments is essential, with preference for experience in GMP manufacturing operations.
- Capable of leading quality initiatives for continuous improvement and system efficiency.
- Proficient in identifying and resolving quality issues, and communicating proposed solutions to management.
- Able to independently manage tasks, with minimal supervision for routine activities.
- Skilled in developing and updating procedures, with the ability to interpret results and make recommendations.
- Strong written communication skills for reporting issues clearly and accurately.
- Capable of handling multiple tasks effectively.
- Comprehensive understanding of US and global cGMP standards, along with quality processes such as material disposition, change control, and CAPA management.
- No heavy lifting or driving is required.
- No exposure to hazardous materials.
