Job Title: Sr. QA Compliance Auditor

Job Description

Summary: The main function of a compliance analyst is to ensure the organization's operations and procedures meet 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.

Job Responsibilities:

• Researching industry compliance regulations and policies.

• Evaluating internal operational and procedural compliance.

• Analyzing and updating existing compliance policies and related documentation.

• Communicating compliance policies and guidelines to Management and designated departments.

• Developing and executing new compliance policies and procedures as required.

• Applying for compliance certification and regulatory approval.

• Developing and maintaining a compliance recordkeeping system.

• Training employees on industry compliance requirements.

• Maintaining communication with compliance regulators and following up on applications.

• Keeping up with compliance requirements and amendments to regulations.

Essential Job Duties:

• Conduct work as identified on the audit activity table (listing on table is not all inclusive but a representative sample).

• 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 client(s).

• Deliver training in 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 via appropriate forum (e.g., Monthly Reports, Site Quality Review, Liaison meetings).

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

• Perform other duties as assigned by management.

Hard Skills

• Regulatory Compliance

• GXP

• GMP Manufacturing

• Audit

• ISO Certified Auditor

• ISO

Job Type

This is a Contract-to-Hire position with a duration of 6 Month(s).

Work Site

This is a hybrid position requiring some days on-site in Indianapolis, Indiana and some days remote.

Work Environment

Candidates must be located in Indianapolis and will need to go into the office. This role is office based but will go into the laboratory when performing audits. 8am-5pm.

Pay Rate: $38/hour

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.