FDA Compliance & Inspections Specialist (Hybrid/Remote)

USA Alston & Bird; Washington (District of Columbia); Hybride; USD 200 000 - 250 000; Plein temps

Résumé du poste

USA Alston & Bird in Washington, D.C. is seeking an experienced FDA consultant to join the Health Care team’s FDA practice. Candidates must have at least 5 years of FDA investigator or senior quality experience. Responsibilities include assisting with compliance issues and providing inspection support.

The position offers flexibility for hybrid or fully remote work and may involve travel. The salary range is between $200,000 and $250,000 based on experience and qualifications.

Qualifications

• Minimum of 5 years as an FDA investigator or compliance officer.
• In-depth knowledge of quality systems and regulations.
• Proficiency in quality management systems.

Responsabilités

• Assist attorneys on CGMP compliance issues.
• Prepare clients for inspections and provide support.
• Provide technical support for remediation efforts.
• Collaborate with cross-functional teams.
• Maintain accurate daily time records.

Connaissances

FDA investigation experience

Knowledge of CGMP compliance

Strong analytical skills

Excellent written and verbal communication

Ability to organize and prioritize tasks

Interpersonal skills

Formation

Bachelor’s degree in chemistry, biology, pharmacy, engineering, or related field

Outils

Quality management systems

Documentation tools

Description du poste

USA Alston & Bird in Washington, D.C. is seeking an experienced FDA consultant to join the Health Care team’s FDA practice. Candidates must have at least 5 years of FDA investigator or senior quality experience. Responsibilities include assisting with compliance issues and providing inspection support.

The position offers flexibility for hybrid or fully remote work and may involve travel. The salary range is between $200,000 and $250,000 based on experience and qualifications.