Quality Assurance Specialist - 2nd Shift

The businesses of Merck KGaA, Darmstadt, Germany; St. Louis (MO); On-site; USD 60,000 - 80,000; Full time

Job summary

A leading company in the life sciences sector is seeking a Quality Assurance Specialist for their St. Louis location. This role involves ensuring compliance with quality standards and improving quality systems across departments. The ideal candidate will have a strong background in quality assurance, with a focus on regulatory compliance and experience in a controlled environment. Strong communication and problem-solving skills are essential for success in this role.

Qualifications

• 3+ years of industry experience in a science field or 5+ years in a Quality role.
• Knowledge of ISO 9001 and ISO 13485 compliance.

Responsibilities

• Implement and maintain Quality Systems for compliance oversight.
• Assist in maintaining department KPIs through timely CAPAs and Deviations.

Skills

Communication

Problem-Solving

Time Management

Negotiation

Education

Bachelor’s Degree in a Science field

Bachelor’s Degree in any field

Tools

MS Word

Excel

Access

Project

PowerPoint

SAP

Trackwise

Job description

Work Location: St. Louis, Missouri
Shift:
Department: LS-SC-PMLQ1B Operational QA Ewing
Recruiter: Genie Hooper

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

Your Role:

The Quality Assurance Specialist - 2nd Shift at our Ewing location provides compliance oversight across the St. Louis ISCO MilliporeSigma Quality Management System (QMS) in collaboration with site personnel. The QA Specialist is responsible for implementing and maintaining Quality Systems and processes to ensure internal and external compliance, and for promoting quality practices that meet or exceed guidelines and regulatory requirements. Responsibilities include maintaining and continuously improving the overall Quality Program.

• Shift: Monday-Thursday 1:30pm - 12am OR Tuesday-Friday 1:30pm - 12am
• Improve quality systems in ISO and non-GMP production environments and drive quality improvement across departments.
• Complete a high volume of work to meet department goals.
• Communicate the status of operations and bring critical deviations to the attention of your manager.
• Communicate with coworkers and interact with other departments regularly.
• Complete work accurately and consistently according to quality guidelines.
• Assist in maintaining department KPIs through timely CAPAs, Deviations, Complaints, and Change Controls.
• Ensure compliance with Life Science and site quality policies and procedures.
• Represent the site during customer and regulatory audits and perform internal audits.
• Assist in investigating customer complaints.
• Contribute to root cause investigations and effectiveness checks of nonconforming incidents, and conduct Quality System training.
• Manage documentation activities, including electronic documentation systems, and write, review, or approve operational procedures, specifications, and controlled documents.

Who you Are

Minimum Qualifications:

• Bachelor’s Degree in a Science field (e.g., Chemistry, Pharmacy, Chemical Engineering) with 3+ years of industry experience

-OR-

• Bachelor’s Degree in any field with 5+ years of experience in a Quality role

Preferred Qualifications:

• Knowledge of ISO 9001 and ISO 13485 and regulatory compliance issues (FDA, USDA, EXCiPACT, ICH, EDQM, IVDR) related to biologic-derived materials, with experience in controlled/regulated environments.
• Current knowledge and/or experience in the fine chemical industry.
• Proficiency in MS Word, Excel, Access, Project, PowerPoint, and familiarity with SAP, Trackwise, etc.
• Excellent verbal and written communication skills, with strong customer service abilities.
• Experience in writing technical documentation and reports.
• Ability to manage multiple tasks and priorities effectively.
• Strong problem-solving skills.
• Good time management and negotiation skills.

The Company is an Equal Employment Opportunity employer. Discrimination based on race, color, religion, age, sex, sexual orientation, national origin, disability, veteran status, or other protected categories is prohibited. Concerns about discrimination should be reported to Human Resources, Legal, or Compliance. The Company will not retaliate against individuals reporting discrimination in good faith.