Job Details

Join our Labcorp Quality department as a QA Senior Compliance Specialist!

Do you have 8 years of experience in a regulated environment in GxP roles? Do you have extensive experience working with FDA and EPA inspectors? Do you have strong knowledge regarding the regulatory bodies and processes to maintain compliance, and experience in hosting remote audits and working with regulatory inspectors? If so, then take your career to the next level at Labcorp as a QA Senior Compliance Specialist.

Join an exceptional organization and an exceptional Quality department.

The role is critical to client service, process improvement oversight, and regulatory compliance expertise required for QA monitoring and non-compliance assessment. Extensive face-to-face experience with Regulatory and Federal Agencies and a strong ability to navigate root cause analysis and respond to FDA and EPA inspections are necessary!

The individual in this role verifies compliance with standard operating procedures (SOPs) and regulations by performing various inspections and audits. The auditor hosts external audits/inspections, leads the development of global QA policies, and provides subject matter expertise for the organization. All employees are responsible for complying with applicable regulations such as GCP, GMP, and GLP in their roles.

Duties and Responsibilities:

• Conduct inspections and audits, host external audits/inspections, facilitate audit responses, and deliver training on audit performance.

• Lead in generating global QA policies related to regulation interpretation and application.

• Provide subject matter expertise and guidance on regulatory topics, supporting the organization and client interactions.

• Host external audits/inspections, such as for cause inspections, non-standard authority inspections, or country-specific inspections, and review responses.

• Participate in and manage global quality initiatives aimed at compliance and efficiency improvements.

• Act as a backup for the QA Manager, report monthly activities, and perform other duties as assigned.

• Ensure compliance with regulatory and QA responsibilities as per controlled documents.

Minimum Education and Experience:

• Bachelor's Degree in Pharmacy, Chemistry, Biology, or related discipline.

• Postgraduate degree (MSC or equivalent) preferred.

• Experience may substitute for education.

• 8 years in a regulatory environment with GxP roles.

• Regulatory expertise with detailed knowledge of specific regulations.

• Extensive face-to-face experience with FDA and EPA inspectors.

• Strong skills in root cause analysis and regulatory response management.

Skills and Competencies:

• Strategic communication with clients.

• Knowledge across multiple operational areas.

• Excellent interpersonal, organizational, decision-making, negotiation, and problem-solving skills.

• Experience leading process improvement initiatives.

Labcorp is recognized as one of the world's best employers and one of the most innovative companies. Join us to make a difference in people's lives!

Application Window: May 6th

Pay Range: $80,000 TO $110,000 annually

Offers are based on skills, experience, relevant degrees/certifications, and internal and market considerations.

Benefits: Employees working 20+ hours/week are eligible for comprehensive benefits including Medical, Dental, Vision, Life, STD/LTD, 401(k), PTO/FTO, Tuition Reimbursement, and Employee Stock Purchase Plan. Less than 20 hours/week employees are eligible for the 401(k) plan only. For more info, click here.

Labcorp is an Equal Opportunity Employer:

We value inclusion and do not tolerate discrimination. Employment decisions are based on qualifications and merit, regardless of protected characteristics. Applicants with arrest or conviction records will be considered per law.

We encourage all to apply.

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