Note: The job is a remote job and is open to candidates in USA. Alston & Bird is a leading international law firm seeking an experienced FDA consultant to join their Health Care team in Washington, D.C. The role involves assisting clients with FDA inspections and compliance, requiring extensive knowledge of quality systems and regulatory requirements.
Responsibilities
- Assist attorneys in supporting manufacturing clients on issues related to Current Good Manufacturing Processes (CGMP) compliance
- Prepare clients for inspections, provide inspection support (remote and on-site)
- Provide technical support for remediation efforts in response to Form FDA 483s, Warning Letters, and other enforcement actions
- Extensive knowledge and experience related to quality systems, investigations, Corrective & Preventative Actions (CAPAs), contamination control, cleaning validation, and data integrity are essential for this role
- Collaborate with cross-functional teams at the Firm and at the client including legal, regulatory, quality, manufacturing, and executive leadership teams
- Draft memos regarding the status of projects
- Maintain current and accurate daily time record
- Perform special projects as assigned
Skills
- Bachelor's degree in chemistry, biology, pharmacy, engineering, or a related field
- FDA experience required
- Minimum of 5 years as an FDA investigator or compliance officer, or industry senior position in global quality assurance
- In-depth knowledge of quality systems, regulatory requirements (21 CFR Parts 210, 211 and related guidance), quality management systems (QMS), and ISO standards
- Strong analytical skills with a focus on root cause analysis and problem-solving
- Excellent written and verbal communication skills, enabling effective interaction with various stakeholders
- Proficient in using quality management systems and documentation tools
- Ability to provide exceptional client service and manage multiple engagements in a fast-paced environment
- Willingness to frequently travel to international and domestic client sites to support inspections, audit, and remediation activities
- Ability to organize and prioritize numerous tasks and complete them under time constraints
- Interpersonal skills necessary in order to communicate and follow instructions effectively from a diverse group of clients, attorneys and staff and provide information with ordinary courtesy and tact
- Work typically requires more than 40 hours per week to perform the essential duties of the position; may require irregular hours
- Ability to travel to private and public buildings, domestically and internationally, via private or public conveyance to assist attorney in attending to client needs on legal matters
Benefits
- Flexibility to work hybrid or a fully remote arrangement
- Extended hours and regular domestic and international travel are often needed to meet client deadlines
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