What are the responsibilities and job description for the Quality Assurance Specialist position at Fortira Inc.?
Role: QA Specialist
Location: Devens, MA (Onsite)
Work Schedule is a 2-week rotation as detailed here: * 5am to 5:30pm, 2 on (Tue, Wed) * 2 off (Thurs, Fri) * 3 on (Sat, Sun Mon) * 2 off (Tues, Wed) * 2 on (Thurs, Fri) * 3 off (Sat, Sun, Mon)
* Holidays included as the needs of the business warrant.
• 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
• 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 might be acceptable.
QUALIFICATIONS REQUIRED
• 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.
