What are the responsibilities and job description for the Sr. Auditor position at 2245 Exelead Inc., USA?

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Your Role

The Quality Auditor is responsible for ensuring compliance with regulatory requirements and internal quality standards within a pharmaceutical environment. This role encompasses conducting audits, managing quality systems, and overseeing supplier quality management to ensure that all operations adhere to cGMP, FDA, and other regulatory standards.

Major Responsibilities :

Conduct Audits :

Scheduling, preparing, conducting, and reporting internal and external audits of manufacturing processes, quality systems, and suppliers.
Evaluate compliance with cGMP, FDA, EU regulations, and internal quality standards.
Prepare detailed audit reports summarizing findings, non-conformances, and recommendations for improvement.
Collaborate with cross-functional teams to develop and implement corrective and preventive actions (CAPAs) in response to audit findings and supplier issues.
Monitor the effectiveness of CAPAs and ensure timely resolution of identified problems.

Quality System Management :

Perform investigations for supplier-related issues and assist in product / process investigations, as assigned.

Assist with implementing new and revised SOPs by performing gap assessments and implementing changes. Back-up to Training Group for providing GMP training or giving GMP presentations to employees.

Participate in mock-inspections, as appropriate.

Drive the escalation of any compliance issues or significant risks identified during audits or when conducting risk assessment.

Meet the requirements outlined in quality standards, quality manuals, policies, procedures, and tools.

Supplier Management :

Conduct assessments and audits of suppliers to evaluate their compliance with quality standards and regulatory requirements.

Collaborate with suppliers to develop and implement corrective actions for identified issues.

Maintain supplier quality metrics and monitor supplier performance to ensure adherence to quality agreements.

Minimum Requirements :

Bachelor's degree in Life Sciences, Pharmacy, Chemistry, or a related field.

Minimum of 7 years of experience in quality assurance, auditing, or supplier management within the pharmaceutical, biotechnology, or cGMP industry.

Domestic travel to supplier sites and other company locations is required. Up to 25%

Auditing experience within regulated biotech / pharma industry

Preferred Qualifications :

Certified Quality Auditor (CQA) or equivalent certification.

Strong knowledge of cGMP, FDA, and EU regulations related to pharmaceuticals.

Ability to interpret and apply regulations, regulatory guidance, and codes and identify and recommend compliance changes as appropriate.

Experience with quality system management and supplier quality assurance processes.

Excellent analytical, problem-solving, and communication skills.

Ability to work independently and collaboratively in a team environment.

Strong attention to detail and organizational skills.

Performance of this work requires limited supervision.

What we offer : We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of our diverse team!

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https : / / www.emdgroup.com / en / company / press-positions.html

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