Work Location: St. Louis, Missouri Shift: Department: LS-SC-PMLQ1 Quality Assurance Recruiter: Katherine Hall
Hiring Manager: Kaitlin Hall
This information is for internals only. Please do not share outside of the organization.
Your Role:
This position is located at the Ewing location. The Quality Assurance Supervisor will have responsibility for quality assurance aspects of the Quality Management System (QMS) to ensure that process and procedures are following ISO 9001, ISO 13485, and current Good Manufacturing Practices (cGMP). The Quality Assurance Senior Supervisor provides leadership and expertise on quality assurance processes and tools. They will lead a team that manages processes such as Deviation, CAPA, Change Control, Training, Complaint Management, and Document Control. In addition, they will have responsibility to ensure that the site is in a state of continuous inspection readiness. The Quality Assurance Senior Supervisor will report directly to the Head of Quality.
Responsibilities include but are not limited to:
Manage Quality Management System (QMS) to ensure alignment with corporate and regulatory standards such as ISO 9001, ISO 13485, and cGMP.
Hire, train and develop qualified staff to ensure effective execution of quality assurance tasks and attain operational and development goals.
Drive achievement of site vision and goals / objectives. • Ensure application of risk management and sound root cause analysis.
Analyze and report quality measures, performance trends and improvements.
Support the initiation and management of quality improvement plans.
Provide Quality Management Systems training to site employees as part of the Learning management system.
Review and approve quality documentation such as procedures, deviation/CAPA plans, risk assessments and change controls to ensure compliance.
Provide quality assurance support to new product introduction and contract manufacturing activities.
Who You Are:
Minimum Qualifications:
Bachelors Degree in Biology, Chemistry, or other Life Science discipline.
3+ years of work experience in a quality leadership role.
Preferred Qualifications:
Experience with ISO 9001, ISO 13485 and 21CFR GMP requirements and guidelines.
Experience with Microsoft Office and Quality systems (Trackwise) software.
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.
