4 manager field quality assurance cell therapy Jobs in devens, ma

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Field Quality Assurance Specialist

Cynet Systems

Devens, MA | Full Time

$88k-106k (estimate)

1 Week Ago

Associate Director, Quality Engineering, Cell Therapy

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Devens, MA | Full Time

$108k-140k (estimate)

2 Days Ago

Field Quality Assurance Specialist

Cynet Systems Devens, MA

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$88k-106k (estimate)

Full Time 1 Week Ago

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Cynet Systems is Hiring a Field Quality Assurance Specialist Near Devens, MA

Job Description:

Pay Range $60hr - $63hr

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:

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.
ble 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.
ble to prepare written communications and communicate problems to management with clarity and accuracy.
ble 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.
ble 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.