Tech Ops and Quality - QA Associate, Quality Operations

Creative Solutions Services, LLC; Norton (MA); On-site; USD 70,000 - 90,000; Part time

Job summary

Creative Solutions Services, LLC is seeking a QA Associate for our Norton, MA site to provide day-to-day QA support across manufacturing, validation, materials, QC, and engineering under GMP guidelines. You will work with cross-functional teams to ensure inspection readiness and continuous quality improvement.

The role requires a Bachelor’s degree in a scientific or engineering discipline and 2–4 years of GMP experience, plus knowledge of cGMP and quality systems such as Veeva or SAP.

Qualifications

• Bachelor's degree in a scientific or engineering discipline (Biology, Chemistry, Biotechnology, etc.) or equivalent experience.
• 2–4 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.

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.

Skills

GMP experience

Quality assurance

Documentation

Attention to detail

Cross-functional collaboration

Education

Bachelor's degree in a scientific or engineering discipline

Tools

Veeva

SAP

Job 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

• 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.
• 2–4 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.