Proclinical Staffing ยท 2 days ago
QA Associate, Quality Operations
Norton, MA
Contract
Onsite
New Grad, Entry LevelProclinical Staffing is seeking a QA Associate, Quality Operations to support the manufacturing of biopharmaceutical products in MA. This position focuses on quality assurance activities across manufacturing, validation, materials, QC, engineering, and facility operations.
Staffing & Recruiting
Hiring Manager
Shannon Briggs
Responsibilities
Review and approve incoming material documentation for GMP use
Provide on-the-floor QA support for manufacturing, including area clearance and changeover operations
Review and approve SOPs, master batch records (MBRs), specifications, risk assessments, and other quality documents
Generate and maintain Quality-related SOPs and controlled forms
Review and approve validation documents and protocol executions to ensure regulatory compliance
Approve QC laboratory qualification documents, including equipment qualifications
Perform executed batch record reviews to ensure accuracy and compliance
Review and approve deviations, CAPAs, change controls, and related investigations in the quality management system
Support partner audits and regulatory inspections by providing document retrieval and subject matter expertise
Approve work orders in the maintenance system to verify equipment maintenance and calibration compliance
Collaborate with internal teams to drive continuous improvement and uphold quality standards
Qualification
Required
Bachelor's degree in a scientific or engineering discipline (e.g., Biology, Chemistry, Biotechnology) or equivalent experience
Familiarity with cGMP regulations (21 CFR Parts 210, 211, 11), ICH Q7-Q10, and Good Documentation Practices
Strong attention to detail, organizational skills, and effective communication abilities
Preferred
Experience with quality systems such as Veeva or SAP is a plus
Company
Proclinical Staffing
At Proclinical Staffing, our life science recruitment services support our partners with permanent and contract vacancies by connecting them with specialist talent across the globe.
Founded in 2005
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase