GMP QA Validation Specialist (Contract)

SGS Consulting; Sanford (NC); On-site; USD 50,000 - 80,000; Part time

Job summary

A leading consulting firm in North Carolina seeks a Specialist in QA Validation to oversee quality systems in GMP operations. The role involves collaborating with various departments to ensure compliance with regulatory standards. Candidates should possess a relevant degree and experience in QA within a biologics manufacturing environment. Strong analytical and communication skills are necessary for success in this fast-paced team setting.

Qualifications

• 3-5+ years in a QA function in a biologics manufacturing facility.
• Knowledge of FDA, EMA regulations and industry best practices.
• Experience with process equipment qualification/validation.

Responsibilities

• Provide QA support and oversight to ensure compliance.
• Author and review controlled documents for quality.
• Assist in regulatory inspections as needed.

Skills

QA compliance

Risk-based qualification

Analytical skills

Problem-solving

Communication

Education

B.S. degree in Biological/Physical/Chemical sciences or equivalent

M.S. degree (preferred)

Job description

A leading consulting firm in North Carolina seeks a Specialist in QA Validation to oversee quality systems in GMP operations. The role involves collaborating with various departments to ensure compliance with regulatory standards. Candidates should possess a relevant degree and experience in QA within a biologics manufacturing environment. Strong analytical and communication skills are necessary for success in this fast-paced team setting.