Senior QA Associate — Biotech Manufacturing (cGMP)

Medix™; Allendale (NJ); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading biopharmaceutical company in New Jersey is seeking an experienced Quality Assurance Associate III. The role involves providing comprehensive QA oversight for manufacturing operations, reviewing deviations and approvals in compliance with FDA cGMP standards. Ideal candidates have over 5 years of experience in the biopharmaceutical industry and strong problem-solving and communication skills. This full-time position promises a dynamic work environment with vital QA responsibilities.

Qualifications

• 5+ years of experience in biopharmaceutical industry is required.
• Proficiency in reviewing deviations and change controls is essential.

Responsibilities

• Provide QA oversight for manufacturing operations.
• Audit and approve batch records and validation reports.
• Serve as QA liaison with various teams ensuring quality standards.
• Write and review SOPs and participate in audits.

Skills

Quality Assurance expertise

FDA/EU cGMP knowledge

Microsoft Office proficiency

Problem-solving skills

Interpersonal communication

Teamwork abilities

Flexibility

Education

Bachelor’s degree in a Science related field

Job description

A leading biopharmaceutical company in New Jersey is seeking an experienced Quality Assurance Associate III. The role involves providing comprehensive QA oversight for manufacturing operations, reviewing deviations and approvals in compliance with FDA cGMP standards. Ideal candidates have over 5 years of experience in the biopharmaceutical industry and strong problem-solving and communication skills. This full-time position promises a dynamic work environment with vital QA responsibilities.