ECLARO · 1 day ago
Global Product Development and Supply - Field Specialist QA Operations
Devens, MA
Contract
Onsite
Mid Level
$59/hr - $62/hr
4+ years expECLARO is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines. They are seeking a Contractor Field QA Specialist responsible for quality activities in accordance with client policies and Global cGMP standards.
Staffing & Recruiting
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
Relevant college or university Associate's or Bachelor's degree required
Minimum 4 years relevant work experience, with experience in a Quality Assurance role
Equivalent combination of education and experience might be 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
Benefits
401k Retirement Savings Plan administered by Merrill Lynch
Commuter Check Pretax Commuter Benefits
Eligibility to purchase Medical, Dental & Vision Insurance through ECLARO
Company
ECLARO
ECLARO is an award-winning professional services firm headquartered in New York City and operating in the U.S., Canada and the Philippines.
1001-5000 employees
H1B Sponsorship
ECLARO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (1)
2023 (1)
2022 (2)
2020 (1)
Funding
Current Stage
Late StageLeadership Team
Nicholas Butcher
QA CTO Label Specialist
Dan Broderick
Chief Delivery Officer
Company data provided by crunchbase