Sr. Lead QA Compliance Analyst - HIRING

HIRING NOW: Sr.

Lead QA Compliance Analyst Interested in this role?

Lead QA Compliance Auditor plays a crucial role in ensuring that the organization's operations and procedures adhere to government and industry compliance standards.

This position involves researching regulations, communicating requirements, and applying for compliance certifications to maintain the highest standards.

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.

* Stay updated 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, including regulatory inspections and strategic clients.

* Facilitate audit responses and support QA-to-QA relationships with key client(s). * Deliver training in the performance of audits (basic, intermediate, complex). * Participate in global Quality initiatives aimed at improving compliance and efficiency.

* Support the reporting of quality metrics and implement corrective actions or process improvements.

* Ensure Regulatory Compliance and Quality Assurance responsibilities are followed as per controlled documents.

* Perform other duties as assigned by management.

Essential Skills * Quality Assurance * Leading Audits * Regulatory Compliance * GXP * GMP Manufacturing * ISO Certified Auditor * Risk Management * Internal Audit * External Audit * Compliance * QA Audit * ISO 13485 Additional Skills & Qualifications * Industry-related bachelor's degree or related experience.

* Compliance management certification preferred.

* Knowledge of compliance management software.

* Advanced analytical abilities.

* Good communication and interpersonal skills.

* 4-7 years of experience in regulatory environment.

* Experience in industry quality systems/standards.

* Excellent interpersonal and organizational skills.

* Ability to influence QA strategy systems/standards.

* Bachelor's Degree in Pharmacy, Chemistry, or Biology-related discipline preferred.

Work Environment This position is based in Indianapolis and requires on-site presence in the office.

The work environment involves collaboration with various departments, using compliance management software and maintaining communication with regulators.

Dress code is professional, and the work schedule adheres to standard office hours.

INTERESTED IN THIS ROLE?

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 ) 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 May 26, 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 for other accommodation options.