Sr. Compliance Specialist

Sr. Compliance Specialist

Location

US-NC-Durham

Category

Regulatory Compliance

Position Type

Full-Time

Working Hours

1st

Shift: Monday - Friday, 8:00am - 5:00pm

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.

Are you interested in joining our team?

The Senior Compliance Specialist is accountable for driving results in a fast-paced environment by effectively performing activities as directed to ensure quality and compliance with applicable regulatory requirements. These activities may include reviewing documents and data, conducting audits and inspections, hosting audits and inspections, and maintaining quality databases. The ideal candidate will assist with the development of SOPs or other quality documents as needed.

The position will perform the role of Lead Inspector for external audits and act as consultant with clients for all level of regulatory issues. The Sr. Compliance Specialist will provide guidance and mentoring for other compliance employees.

Hybrid role with 3 days expected on-site.

• 1st Shift: Monday - Friday, 8:00am - 5:00pm.

• Performs quality review and approval of documents, data, protocols, and/or reports.
• Performs internal and external quality audits and/or inspections.
• Serves as a Lead Inspector for external audits.
• Hosts client audits and inspections.
• Hosts regulatory inspections.
• Maintains quality databases.
• Assists with the implementation and supports quality systems, including but not limited to vendor management,
• training, internal audit program, and overall regulatory inspectional readiness initiatives.
• Assists with quality improvement initiatives as needed.
• Consults with clients on all levels of regulatory issues.
• Assists with development of SOPs or other quality documents as needed.
• Maintains accurate files and records.
• Serves as an effective member of the Compliance team and may serve as a mentor to others in area of
• expertise.
• Complies with company polices and SOPs.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Other duties as assigned.

• 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.

• 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 math skills.
• Good computer skills and knowledge of Microsoft Office products.
• Ability to be trained and to mentor.
• Ability to interact well with clients and regulatory agents.
• Ability to interact well with employees at all levels.
• Ability to negotiate.
• Ability to lead audits.
• Ability to act as a consultant.

• Up to 5% travel expected.

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.