What are the responsibilities and job description for the Field QA Specialist position at Synectics Inc.?
Job Description
- Responsible for quality activities for the SUF in accordance with policies, standards, procedures, and Global cGMP.
- 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.
- 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.
- 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.
- Relevant college or university degree required.
- Minimum 4 years relevant work experience, with experience in a Quality Assurance role.
- 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.
- Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.
- Must have sound knowledge and experience in FDA regulated cGMP warehousing, Quality, and compliance environments.
- Prefer knowledge of GMP Manufacturing operations and processes.
- Able to recognize conflict and notify management with proposed recommendations for resolution.
- Must possess an independent mindset.
- Work is self-directed.
- 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.