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HIRING : Senior QA Compliance Auditor

HIRING : Senior QA Compliance Auditor

Indianapolis StaffingIndianapolis, IN, US
1 day ago
Job type
  • Full-time
Job description

Sr. QA Compliance Auditor

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.

Responsibilities :

  • Research 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 Skills :

  • Quality Assurance
  • Audit
  • Regulatory Compliance
  • GXP
  • GMP Manufacturing
  • ISO Certified Auditor
  • Risk Management
  • Internal Audit
  • External Audit
  • Corrective and Preventative Actions (CAPA)
  • Laboratory Reports
  • Continuous Improvement Analyst Certification (CQI)
  • Root Cause Analysis
  • ISO 13485
  • Compliance
  • QA Audit
  • Qualifications :

  • Bachelor's degree in a related field such as Pharmacy, Chemistry, or Biology.
  • Compliance management certification preferred.
  • Knowledge of compliance management software.
  • Advanced analytical abilities.
  • Interpersonal skills and organizational proficiency.
  • Experience in industry quality systems and standards.
  • Proficiency in Quality Assurance, Audit, and Regulatory Compliance.
  • Experience in GXP, GMP Manufacturing, and ISO certification.
  • Strong skills in Risk Management, Regulatory Audit, and Compliance.
  • Certification as an ISO Certified Auditor.
  • 5-7 years of experience in a regulatory environment.
  • Excellent communication, decision-making, and problem-solving skills.
  • 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 consideration :

  • Interview availability this week only
  • 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 reaching out and 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 and / or CALL / TEXT ME : 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 Nov 6, 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, please email actalentaccommodation@actalentservices.com for other accommodation options.

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    Compliance Auditor • Indianapolis, IN, US

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