Immediate need for a talented Field Specialist QA Operations. This is a 12 months Contract opportunity with long-term potential and is located in Devens, MA(Onsite). Please review the job description below and contact me ASAP if you are interested.
Job ID: 24-26403
Pay Range: $50 - $56/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
Key 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.

Key Requirements and Technology Experience:

• High School Degree required
• Relevant college or university degree preferred.
• 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.
• 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.

Our client is a leading Pharmaceutical industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.
Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.