Merck Gruppe
Work Location: Indianapolis, Indiana
Shift: No
Department: LS-SC-POEQC2 Indianapolis Auditing & Compliance
Recruiter:Leah S Westley
This information is for internals only. Please do not share outside of the organization.
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: 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. Who You Are Minimum Requirements: Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or a related field or equivalent experience. 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 or equivalent. 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.
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
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This information is for internals only. Please do not share outside of the organization.
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: 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. Who You Are Minimum Requirements: Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or a related field or equivalent experience. 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 or equivalent. 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.
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
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