Senior QA Validation | Cell Therapy GMP Compliance

BioSpace; Raritan (NJ); On-site; USD 93,463 - 122,670; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company match

Paid parental leave

15 vacation days

Flexible spending and health savings accounts

Well-being initiatives

Job summary

A biopharmaceutical company is looking for a QA Validation Specialist III in Raritan, NJ. This role involves providing quality oversight for validation activities within a cell therapy manufacturing plant. Candidates should have at least 4 years of experience in quality assurance, strong knowledge of cGMP regulations, and excellent communication skills. The position offers a dynamic work environment focusing on compliance and continuous improvement initiatives.

Qualifications

• Minimum 4 years relevant experience in quality assurance or manufacturing compliance.
• Knowledge of cGMP regulations and FDA/EU guidance.
• Strong knowledge of GxP compliance.
• Experience with cGMP regulatory body audits.

Responsibilities

• Provide quality oversight for computer systems validation and process validation.
• Review and approve qualification and validation documentation.
• Assist in the development of validation and qualification policies and procedures.
• Oversee data integrity of systems and equipment.

Skills

GMP compliance

Interpersonal skills

Communication skills

Decision-making

Attention to detail

Team collaboration

Tools

Microsoft Office

Job description

A biopharmaceutical company is looking for a QA Validation Specialist III in Raritan, NJ. This role involves providing quality oversight for validation activities within a cell therapy manufacturing plant. Candidates should have at least 4 years of experience in quality assurance, strong knowledge of cGMP regulations, and excellent communication skills. The position offers a dynamic work environment focusing on compliance and continuous improvement initiatives.