QA Associate, Quality Operations

LanceSoft Inc

Norton, MA

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JOB DETAILS

JOB TYPE

Full-time

SKILLS

Biology, Biotech and Pharmaceutical, Calibration, Change Control, Chemistry, Communication Skills, Continuous Improvement, Cross-Functional, Detail Oriented, Documentation, Equipment Maintenance/Repair, GMP (Good Manufacturing Practices), Maintain Compliance, Manufacturing, Organizational Skills, Process Improvement, Quality Assurance, Quality Control, Quality Management, Regulations, Regulatory Requirements, Risk Analysis, SAP, Standard Operating Procedures (SOP), Validation Documentation, Validation Plan

LOCATION

Norton, MA

POSTED

30+ days ago

About the Role The QA Associate will help ensure that life-changing biopharmaceutical products are manufactured to the highest standards. The QA Associate will provide day-to-day QA support across manufacturing, validation, materials, QC, engineering and facility operations at our Norton site, partnering with cross-functional teams to maintain GMP compliance and inspection readiness. Key Responsibilities Provide raw material support, including review/approval of incoming material documentation and release for GMP use. Deliver on-the-floor QA support to manufacturing, including area clearance and changeover operations, ensuring readiness for production activities. Review and approve SOPs, master batch records (MBRs), specifications, risk assessments, and quality documents. Generate and maintain Quality-related SOPs and controlled forms. Review and approve validation documents and protocol executions to confirm compliance with approved procedures and regulatory requirements. Review and approve QC laboratory qualification documents, including equipment qualification. Perform executed batch record review and approval 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, including document retrieval and subject matter input. Approve work orders in the maintenance system to verify equipment maintenance and calibration compliance. Collaborate with internal cross-functional teams at the Norton facility to drive continuous improvement and quality excellence. Qualification/Skills Bachelors degree in a scientific or engineering discipline (Biology, Chemistry, Biotechnology, etc.) or equivalent experience. 24 years of GMP experience in Quality, Manufacturing, or QC. Knowledge of cGMP regulations (21 CFR Parts 210/211/11, ICH Q7/Q10) and Good Documentation Practices. Strong attention to detail, organizational skills, and the ability to communicate effectively across teams. Experience with quality systems (e.g., Veeva, SAP) is a plus.

About the Company

LanceSoft Inc

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

COMPANY SIZE

2,000 to 2,499 employees

INDUSTRY

Staffing/Employment Agencies

FOUNDED

2000

WEBSITE

http://www.lancesoft.com/