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Our client, a leading pharmaceutical company, is hiring a Field Specialist QA Operations consultant on a contract basis.
Work Location Devens, MA Summary Field QA Specialist ( 2nd shift schedule 2PM - 10PM) Devens, MA This role is 100% Onsite Working Hours are from 2PM - 10PM, Monday - Friday JOB RESPONSIBILITIES • Perform QA on the floor activities. • Ensure manufacturing compliance with applicable procedures and batch records. • Perform real time review of manufacturing batch records. • Review manufacturing shop floor documentation. EDUCATION REQUIREMENTS • High School Degree required • Relevant college or university degree preferred. • Minimum 2 years relevant work experience, with experience in a Quality Assurance role. QUALIFICATIONS REQUIRED • Equivalent combination of education and experience acceptable. • Must be action-oriented and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking. • Understands continuous improvement and improves efficiency and productivity within the group or project. • Builds relationships internally within and with cross functional teams. • Must have sound knowledge and experience in FDA regulated cGMP warehousing, Quality, and compliance environments. Prefer to also have knowledge of GMP Manufacturing operations and processes. • Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies. • Routinely recognizes and resolves Quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues. • Able to recognize conflict and notify management with proposed recommendations for resolution. • Must possess an independent mindset. Work is self-directed. • Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision. • Confident in making decisions for non-routine issues. • Develops and revises procedures. • Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution. • Able to prepare written communications and communicate problems to management with clarity and accuracy. • Able to effectively multi-task. • Knowledge of US and global cGMP requirements. Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles. • Must be skilled in planning and organizing, decision-making, and building relationships. • Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management. • Able to effectively multi-task. • Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality Risk Management principles. • Must be skilled in planning and organizing, decision-making, and building relationships. • Knowledge of quality processes, change control, product complaints, deviations, investigations, and CAPA management.- ID: #49476972
- State: Massachusetts Devens 01434 Devens USA
- City: Devens
- Salary: USD TBD TBD
- Job type: Contract
- Showed: 2023-03-15
- Deadline: 2023-05-13
- Category: Et cetera