Quality Assurance Specialist

Work Location: St. Louis, Missouri
Shift:
Department: LS-SC-PMLQ4B Operational QA Broadway
Recruiter: Guadalupe Barragan

This information is for internals only. Please do not share outside of the organization.

Your Role:

The Quality Assurance Specialist provides compliance oversight across the St. Louis ISCO MilliporeSigma Quality Management System (QMS) in collaboration with site personnel. As a QA Specialist you are responsible for the implementation and maintenance of Quality Systems and processes to ensure internal and external compliance and the promotion of quality practices that meet or exceed required guidelines and regulatory requirements. Responsibilities include maintenance and continuous improvement of the overall Quality Program.

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• Improve and maintain quality systems in ISO production environments, ensuring compliance with Life Science and site quality policies.
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• Manage the electronic documentation system, which includes writing, reviewing, and approving controlled documents such as Standard Operating Procedures (SOPs), Specifications, and Master Manufacturing & Packaging Procedures.
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• Oversee training management, including metric reporting and managing the electronic training platform, to meet departmental goals.
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• Assist and/or act as a Lead Auditor in conducting internal audits to ensure compliance with quality policies.
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• Support the department's key performance indicators (KPIs) by ensuring the timely completion of Corrective and Preventive Actions (CAPAs), Deviations, Complaints, and Change Controls.
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• Assist in the investigation of customer complaints and contribute to Root Cause Investigations and Effectiveness Checks for nonconforming incidents.
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• Regularly communicate with coworkers and interact with other departments to support overall quality objectives.
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• Conduct specific Quality System Training relevant to various job functions.
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Physical Requirements:

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• Environmental conditions: Varies depending on specific job responsibilities.
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• 70-100% Office Environment, 10-30% On-the-floor QA activities/observation.
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• Physical requirements: Give site tours of facilities including use of stairs.
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Who You Are

Minimum Qualifications:

• Bachelor's Degree in Life Science (Chemistry, Pharmacy, etc) or Engineering (Chemical, Process, etc) and 5+ years of experience working in the Life Science industry.

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OR

• Bachelor's Degree in any discipline and 5+ years working in a Quality Assurancerole.

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OR

• Masters Degree in Life Science (Chemistry, Pharmacy, etc) or Engineering (Chemical, Process, etc) and 2+ years of experience working in the life science industry.

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Preferred Qualifications:

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• 2+ years of ISO 9001 and ISO 13485 and regulatory compliance issues (i.e., FDA, USDA, EXCiPACT, ICH, EDQM, IVDR) related to biologic derived materials, and prior experience working in a controlled/regulated environment
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• Good computer skills, including proficiency in MS Word, MS Excel, MS Access, MS Project, MS PowerPoint, and ability to learn and operate using other specific application software (SAP, Trackwise, etc.).
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• Excellent communication (verbal & written) and customer services skills.
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• Good writing skills and experience writing technical documentation & reports.
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• Ability to simultaneously manage multiple tasks/priorities.
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• Good problem-solving skills/abilities.
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• Good time management and negotiating skills.
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• Capacity for independent work.
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RSREMD

Pay Range for this position: $66,800.00-$109,300.00.

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.

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.