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Quality Assurance Audit Lead

Your role:

The Sr. Quality Assurance Specialist reports to the Head of Quality will be responsible for the audit readiness activities within the Biologics Midwest sub cluster.  This individual will manage all aspects of the sites’ audit program, provide employee training and support, and support the quality management system. Qualified candidates will possess strong inspections/auditing skills, have a demonstrated ability to solve problems and implement sustainable solutions, and effectively communicate with external auditors as well as multiple functional groups within the organization.

 

  • Support all audit/inspection types (e.g. internal, external, vendor, regulatory inspections, registrar).
  • Plan, conduct, and report audits according to the sites’ quality management system and electronic document management system processes.
  • Communicate effectively, verbally and in writing, with all internal and external clients.
  • Support the tracking and trending of all compliance reports and audit activities.
  • Provide root cause guidance to CAPA owners and/or conducts root cause analysis when assigned.
  • Champion the timely management of audit findings and CAPAs.
  • Follow-up and verify effectiveness checks.
  • Work with all levels of internal / external personnel in a professional and organized manner.
  • Identify and implement process improvements, with a focus on the audit program.
  • Escalate quality concerns and problems to the Head of Quality.

 

Who you are:

 

Basic Qualifications:

  • Bachelor’s Degree in chemistry, biology, pharmacy, biomedical engineering, or related life science discipline.
  • 5+ years of quality experience working within a ISO 9001, ISO 13485 and / or 21CFR820 GMP certified manufacturing environment    
  • 5+ years of experience working in at least one of the following areas:  Audits, Quality Ops, QC Labs, Quality Management Systems, Validation, Supplier Management  

 

Preferred Qualifications:

  • Experience working w/ customers and internal/external stakeholders.
  • Strong written and verbal communication skills.
  • Strong command of quality systems supporting ISO 9001, ISO 13485, FDA regulations (such as 21CFR820, 21CFR 210 & 211).  MDSAP a strong plus.
  • Certifications: CQE, CQA, CMQ/OE, CQPA a plus

 

 

Job Requisition ID:  209370
Location:  St. Louis
Career Level:  D - Professional (4-9 years)
Working time model:  full-time

Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options.

US Disclosure
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.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.

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