Joulé · 3 hours ago
Field QA Operations Specialist
Harvard, MA
Contract
Onsite
Mid Level
4+ years expJoulé is a leader in delivering outsourced services and workforce solutions across North America, and they are seeking a Field QA Operations Specialist for their QA Operations organization. The role involves ensuring quality activities for the LSCC in accordance with company policies and global cGMP standards, as well as performing QA on the floor activities and ensuring manufacturing compliance.
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
Qualification
Required
Associate's or Bachelor's degree required
Minimum 4 years relevant work experience, with experience in a Quality Assurance role
Understands continuous improvement and improves efficiency and productivity within the group or project
Must have sound knowledge and experience in FDA regulated cGMP warehousing, Quality, and compliance environments
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
Develops and revises procedures
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
Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management
Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality Risk Management principles
Knowledge of quality processes, change control, product complaints, deviations, investigations, and CAPA management
Benefits
Health and welfare benefits coverage options including medical
Dental
Vision
Spending accounts
Life insurance
Voluntary plans
Participation in a 401(k) plan
Company
Joulé
At Joulé, we believe our world is filled with possibilities – where character, integrity, and commitment drive our purpose.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase