Sr. Compliance Specialist - Audit , GMP

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.

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Job Summary

The Senior Compliance Specialist is accountable for driving results in a fast-paced environment by effectively performing activities directed to ensure quality and compliance with applicable regulatory requirements. These activities may include reviewing documents and data, conducting audits and  supporting inspections, and maintaining quality databases. The ideal candidate will assist with the development of SOPs or other quality documents as needed. The Senior Compliance Specialist will perform the role of Lead Inspector for external audits and act as consultant with clients for all levels of regulatory issues. The Sr. Compliance Specialist will provide guidance and mentoring for other compliance employees.

On-Site Expectations

• Hybrid position. Must be on-site for client audits. Occasional travel to other sites for audits.
• 1st Shift: Monday - Friday, 8:00am - 5:00pm.

Responsibilities

• Host client audits and coordinate with clients.
• Coordinate with internal team members to complete responses.
• Write and coordinate audit responses.
• Perform quality review and approval of documents, data, protocols, and/or reports.
• May assist with supplier quality audits and/or inspections.
• May assist with evaluation of supplier changes and notifications and make assessment of impact accordingly.
• Maintain quality databases and support quality systems.
• Assist with development of SOPs or other quality documents as needed.
• Consult with clients on all levels of regulatory issues.
• Serve as an effective member of the Compliance team and serve as a mentor in area of expertise.
• Comply with company policies and SOPs.
• Assist with quality improvement initiatives as needed.
• Ensure timely completion and compliance with cGMP and all other relevant company training requirements.
• Other duties as assigned.

Qualifications

• Bachelor’s degree in Chemistry, Biology, or related field with 10+ years of GMP related experience, or Master’s degree in related field with 5+ years of related experience, or equivalent educational and work experience.
• Client hosting experience in the pharmaceutical industry preferred.
• Supplier management experience in pharmaceutical industry is a plus.
• Client-facing experience required.

Knowledge, Skills, and Abilities

• Strong knowledge of regulations and SOPs applicable to area of responsibility and keeps abreast of new regulations and regulatory guidance in areas of expertise.
• Good written and oral communication skills.
• Good computer skills and knowledge of Microsoft Office products.
• Ability to be trained and to mentor.
• Ability to interact well with employees at all levels.
• Ability to negotiate.
• Ability to lead audits.
• Ability to act as a consultant.

Travel Expectations

• Up to 10% travel for audits.

Physical Demands and Work Environment

The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk and listen. The employee is frequently required to stand, walk, and sit. The employee may be occasionally required to climb or balance.