We are immediately hiring for a Senior QA Compliance Auditor here in Indiana! This role will primarily focus on performing and leading audits and ensuring compliance within a clinical laboratory environment. This is a long-term career opportunity and we are looking for a candidate with experience in an FDA or similarly regulated environment (experience in pharmaceutical, clinical, medical, or similar industries highly preferred).

Description:

The main function of a SR. QA Compliance Auditor is to ensure that the organization's operations and procedures meet government and industry compliance standards. This role involves researching regulations and policies, communicating requirements, and applying 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 (e.g., regulatory inspections, strategic clients) and assist with the facilitation of audit responses.

• Support the QA–to-QA relationship with key clients.

• Deliver training in the performance of audits (basic, intermediate, complex).

• Participate in global Quality initiatives aimed at improving compliance and/or efficiency of the QA organization.

• Support the reporting of quality metrics and implementation of necessary corrective actions and/or process improvements.

• Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities are followed as indicated in applicable controlled documents.

• Perform other duties as assigned by management.

Qualifications:

• Must have an industry-related Bachelor's degree (Chemistry, Biochemistry, Biology, Medical Laboratory Science, Pharmaceutical Sciences, etc.)

• Must have multiple years of experience leading internal and/or external audits (internal company audits vs. being audited by the FDA or similar regulatory bodies).

Pay and Benefits

The pay range for this position is $38.00 - $38.40/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 Mar 21, 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.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

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 process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.