QA Lead: Site Audits & Quality Governance

ECHO Consulting Group Inc; Juncos (PR); On-site; USD 60,000 - 90,000; Full time

Benefits offered by this job

Competitive compensation package

Professional development

Job summary

ECHO Consulting Group is a leader in providing solutions for the pharmaceutical, biotechnology, medical devices, and food industries. ECHO Consulting Group delivers high-quality solutions in CQV, quality management, regulatory compliance, manufacturing support, and project management.

Perform one or more of the following duties and responsibilities in support of Quality Assurance program under minimal supervision.

Qualifications

• Experience reviewing and approving change controls, deviations, CAPAs and QA protocols.
• Knowledge of GDP and electronic quality systems is highly desired.
• Ability to collaborate with Manufacturing, Engineering and Process Development.

Responsibilities

• Review and approve MPs, validation protocols and reports.
• Approve EMS/BMS alarms, environmental reports and change controls.
• Lead site audits and investigations, own QA procedures.
• Represent QA on NPI team and support incident triage.
• Provide lot disposition and authorize shipments.

Skills

Project management

Organization

Cross-functional leadership

Negotiation

Regulatory interaction

Data trending

Independent work

Communication skills

Education

Doctorate or Master’s + 3 yrs rel exp; or Bachelor’s + 5 yrs rel exp; or Associate’s + 10 yrs rel exp; or HS diploma + 12 yrs rel exp

Tools

Electronic Quality Systems

GDP knowledge

CAPA management tools

Job description

ECHO Consulting Group is a leader in providing solutions for the pharmaceutical, biotechnology, medical devices, and food industries. ECHO Consulting Group delivers high-quality solutions in CQV, quality management, regulatory compliance, manufacturing support, and project management.

Perform one or more of the following duties and responsibilities in support of Quality Assurance program under minimal supervision.