Interested in this role? Reach out directly to apply TODAY to Grace Williams at grawilliams@actalentservices .com
Job Description
Join a leading central laboratory that provides testing and bioanalysis services as a Lead QA Compliance Auditor within the Quality Assurance team. This role focuses on ensuring that the organization's operations and procedures meet both government and industry compliance standards. A compliance analyst may research regulations and policies, communicate requirements, and apply for compliance certifications on behalf of the organization.
ResponsibilitiesResearch industry compliance regulations and policies.Evaluate internal operational and procedural compliance.Analyze and update existing compliance policies and related documentation.Communicate compliance policies and guidelines to management and designated departments.Develop and execute new compliance policies and procedures as required.Apply for compliance certification and regulatory approval.Develop and maintain a compliance recordkeeping system.Train employees on industry compliance requirements.Maintain communication with compliance regulators and follow up on applications.Keep up with compliance requirements and amendments to regulations.Conduct work as identified on the audit activity table.Contribute to global QA policies on interpretation/application of regulations.Provide subject matter expertise to projects and support team in CAPA plan creation.Host external audits/inspections and assist with audit response facilitation.Support the QA-to-QA relationship with key clients.Deliver training in the performance of audits.Participate in global quality initiatives aimed at improving compliance and/or efficiency.Support the reporting of quality metrics and implementation of necessary corrective actions.Essential SkillsQuality AssuranceAuditRegulatory ComplianceGXPGMP ManufacturingISO Certified AuditorRisk ManagementInternal AuditExternal AuditCorrective and Preventative Actions (CAPA)Laboratory ReportsContinuous Improvement Analyst Certification (CQI)Root Cause AnalysisISO 13485ComplianceQA AuditQualificationsBachelor’s Degree in a Life Science field. (i.e. Pharmacy, Chemistry or Biology or related discipline) or related experience.Experience of industry quality systems/standards.Knowledge of compliance management software.Advanced analytical abilities.Excellent interpersonal, communication, organizational, skills.4-7 years of experience in a regulatory environment.Ability to influence QA strategy and apply regulatory knowledge.Postgraduate degree in science or management related discipline, preferable.Work Environment
Candidates must be willing to work in Indianapolis and will need to report to the office. The work environment is dynamic and requires interaction with various departments and regulators to maintain compliance standards .
INTERESTED IN THIS ROLE? SEE BELOW TO APPLY NOW FOR IMMEDIATE CONSIDERTATION:
Interview availability this week
I am scheduling interviews for this position and conducting phone interviews as early as today. All candidates will be considered immediately within 24 hours of applying directly to Grace Williams.HOW TO APPLY DIRECTLY :Email your updated resume, brief intro about your interest, preferred method of communication for you (i.e., call, email, text) to grawilliams@actalentservices. com or call me directly at (317-567 -6610)Pay and Benefits
The pay range for this position is $40.86 - $41.10/hr.
Eligibility requirements apply to some benefits and may depend on your job
classification and length of employment. Benefits are subject to change and may be
subject to specific elections, plan, or program terms. If eligible, the benefits
available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Indianapolis,IN.
Application Deadline
This position is anticipated to close on Aug 7, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.