Tech Ops and Quality - QA Associate, Quality Operations - Contract
TalentBurst, Inc.
- Norton, MA
- 1 day ago
- $47.31 Per Hour
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Skills
- Biologyunmatched
- Biotech and Pharmaceuticalunmatched
- Calibrationunmatched
- Change Controlunmatched
- Chemistryunmatched
- Communication Skillsunmatched
- Continuous Improvementunmatched
- Cross-Functionalunmatched
- Detail Orientedunmatched
- Documentationunmatched
- Equipment Maintenance/Repairunmatched
- GMP (Good Manufacturing Practices)unmatched
- Maintain Complianceunmatched
- Manufacturingunmatched
- Organizational Skillsunmatched
- Process Improvementunmatched
- Quality Assuranceunmatched
- Quality Controlunmatched
- Quality Managementunmatched
- Regulationsunmatched
- Regulatory Requirementsunmatched
- Risk Analysisunmatched
- SAPunmatched
- Standard Operating Procedures (SOP)unmatched
- Technical Operationsunmatched
- Validation Documentationunmatched
- Validation Planunmatched
Description
Industry: Pharmaceuticals
Title: QA Associate, Quality Operations
Job ID: NORT000038
Location: Norton, MA (Onsite)
Duration: 06 months contract (+Possibility of extension)
*High possibility of role converting to FTE but not guaranteed.
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
Qualification/Skills
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Title: QA Associate, Quality Operations
Job ID: NORT000038
Location: Norton, MA (Onsite)
Duration: 06 months contract (+Possibility of extension)
*High possibility of role converting to FTE but not guaranteed.
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
- Bachelor's 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.
#ZR
#RESCIE1
#Linkd
Numbers & Facts
| Location | Norton, MA |
| Industry | Staffing/Employment Agencies |
| Salary | $47.31 Per Hour |
| Company Size | 5,000 to 9,999 employees |
| Year Founded | 2002 |
| Website | http://www.talentburst.com/ |
About Company
For over 20 years, TalentBurst Inc. has been an award-winning provider of cutting-edge Workforce Management Solutions. With a strong commitment to staying ahead in the tech landscape, we pioneer innovative approaches to talent acquisition. Our expertise spans Life Sciences, and Healthcare Staffing, Banking, Financial, IT, and Engineering, as well as Global Employer of Record (EOR), Agent of Record (AOR), State, Local Government and Education (SLED), and IC validation/compliance services. Additionally, our division, TalentProcure, leads the industry with offerings such as High Hazard Payroll, Managed Services, and Vendor on Premise (VOP) solutions.
Due to our prioritization of excellent standards, we are Joint Commission Certified and are a certified Minority Business Enterprise (MBE) in the USA and Canada. Supporting over 130 Fortune 500 companies globally, we excel in navigating the landscape of talent acquisition. In a world of constant change, we embrace developing people-centric solutions that address the unique demands of our clients. Stay connected by visiting our website and following us on social media!