Quality Assurance Associate III - 244917

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

Quality Assurance Associate III - 244917

Responsibilities

• On-site role providing QA oversight for manufacturing operations.
• Review and approve deviations, non-conformance events, change requests, and change controls.
• Audit and approve pre-/post-executed batch records, validation reports, and product/label specifications in compliance with cGMP and internal procedures.
• Prepare release checklists, CoAs, and related documentation to support timely batch disposition.
• Serve as QA liaison with manufacturing, project teams, clients, and regulatory bodies, ensuring quality standards are met and issues are appropriately escalated.
• Write, review, and revise SOPs; lead/participate in audits, inspections, walkthroughs, and process improvement initiatives.
• Represent QA in meetings and act as the single point of contact for designated clients.
• May perform qualified visual inspections of final product when required.

Education & Experience

• 5+ years of experience in the biopharmaceutical industry
• Bachelor’s degree in a Science related field preferred

Knowledge, Skills & Abilities

• Strong knowledge of FDA/EU cGMP requirements and QA documentation practices.
• Proficient with Microsoft Office; able to perform accurate calculations and data recording.
• Experienced in reviewing/approving deviations, NCEs, and change controls.
• Skilled in problem-solving, decision-making, and prioritizing competing tasks.
• Effective communicator with strong interpersonal and teamwork abilities.
• Flexible and adaptable to changing priorities and business needs.
• Demonstrated ability to work independently on complex issues while building productive internal/external relationships.

Seniority level

• Associate

Employment type

• Full-time

Job function

• Quality Assurance

Industries

• Biotechnology Research and Pharmaceutical Manufacturing