Advantage Technical · 3 hours ago
Quality Control Analyst
Norton, MA
Full-time
Onsite
Mid, Senior Level
$44.60/hr - $44.60/hr
4+ years expAdvantage Technical is seeking a Quality Control Analyst II to support Quality Control activities across development through commercial manufacturing. This role involves performing analytical testing, contributing to laboratory operations, and ensuring compliance with quality standards.
Staffing & Recruiting
No H1B
U.S. Citizen OnlyHiring Manager
Damarys Zambrano, MSIOP
Responsibilities
Perform routine and non-routine analytical testing of increasing complexity to support raw materials, in-process samples, finished product release, and stability programs, in accordance with approved SOPs
Execute testing schedules while maintaining accurate, current training records and ensuring timely completion of assignments to meet QC timelines and quality metrics
Support laboratory operations through reagent preparation, sample handling, equipment maintenance, and inventory management
Ensure timely submission of analytical data; may serve as a data reviewer to support efficient data availability
Perform role-specific operational tasks, such as raw material sampling and testing, environmental monitoring, and product testing
Contribute to the revision and maintenance of controlled documents, including SOPs, work instructions, and test methods
Adhere to internal policies, procedures, and regulatory requirements, including GMP, GLP, and applicable ICH guidelines
Collaborate with QC and cross-functional teams to support seamless laboratory operations and overall organizational goals
Participate in inspection readiness activities and support internal audits and regulatory inspections, as needed
Support investigations, data trending, and continuous improvement initiatives to enhance QC processes, efficiency, and effectiveness
Assist with data verification activities in support of regulatory submissions, as required
Pursue ongoing training to expand technical expertise and regulatory knowledge
Qualification
Required
Must be a US citizen or green card holder
4–8 years of experience in the pharmaceutical or biotechnology industry within a regulated QC or analytical laboratory environment
Hands-on GMP experience in analytical testing is required
Ability to work effectively under direction with strong attention to detail in a dynamic environment
Strong communication and teamwork skills
Preferred
Bachelor's degree in Chemistry, Biology, Biochemistry, or a related scientific field preferred
Associate's degree, Biotech certificate, or equivalent experience will be considered
Experience with data analysis and data trending is preferred
LIMS (preferred)
Company
Advantage Technical
Advantage Technical aligns people and companies to create opportunity.
10001+ employees
Funding
Current Stage
Late StageCompany data provided by crunchbase