QA Associate, Quality Operations

BioPharma Consulting JAD Group • Contract • Norton, MA, US • 3m ago

The QA Associate, Quality Operations is a floor-facing Quality Assurance role that supports day-to-day manufacturing operations in a GMP-regulated environment. This position was opened due to increased team activity and requires strong collaboration with cross-functional partners across Manufacturing, Quality Control, Validation, Engineering, Facilities, and Materials. The role is ideal for an early-career QA professional with hands-on GMP experience who is comfortable working on the production floor and engaging with diverse teams.

Key Responsibilities

Provide on-the-floor QA support to manufacturing operations, including area clearance, line clearance, and changeover activities to ensure production readiness.
Support raw material processes, including review and approval of incoming material documentation and release for GMP use.
Review and approve SOPs, Master Batch Records (MBRs), specifications, risk assessments, and other GMP documentation.
Generate, revise, and maintain quality-related SOPs and controlled forms.
Perform executed batch record review and approval to ensure accuracy, completeness, and compliance.
Review and approve deviations, CAPAs, change controls, and associated investigations within the quality management system.
Review and approve validation protocols, reports, and protocol executions in alignment with regulatory and site requirements.
Review and approve QC laboratory qualification and equipment qualification documentation.
Approve work orders in maintenance systems to verify equipment maintenance and calibration compliance.
Support inspection readiness activities, partner audits, and regulatory inspections, including document retrieval and subject matter support.
Collaborate closely with cross-functional teams to drive continuous improvement and promote a strong quality culture.

Technical Skills

Experience using quality and enterprise systems such as:
- SAP (highly used)
- Veeva Vault (highly used)
- LIMS (plus)
- Infor / CMMS systems (nice-to-have)
Proficiency in reviewing and managing GMP documentation and quality system records.

Requirements

Qualifications & Experience

Bachelor's degree in a scientific or engineering discipline (e.g., Biology, Chemistry, Biotechnology) required.
Minimum of 2 years of professional GMP experience; 2-4 years preferred.
Open to candidates with up to :10 years of experience, provided GMP exposure aligns with the role scope.
At least one role with direct, hands-on GMP experience.
Experience supporting manufacturing or operational environments required.
Knowledge of cGMP regulations (21 CFR Parts 210/211/11, ICH Q7/Q10) and Good Documentation Practices (GDP).

Benefits