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Quality Assurance Associate jobs in USA
Quality Assurance Associate jobs in USA, Unlock Your Career Potential as a QA at Xeris Pharmaceuticals in Chicago, USA.
Are you a detail-oriented individual with a passion for quality control in the pharmaceutical industry? If so, Xeris Pharmaceuticals, Inc. in Chicago, USA, has an exciting opportunity for you! As a Quality Assurance Associate, you will play a pivotal role in ensuring the highest standards of quality across the company’s pharmaceutical manufacturing processes.
Quality Assurance Associate jobs in USA Details
- Position: Quality Assurance Associate
- Company: Xeris Pharmaceuticals, Inc.
- Location: Chicago, Illinois
Job Overview:
- Job Type: Hybrid (On-site and Remote)
- Employment Type: Full-time
- Experience Level: Entry level
- Number of Applicants: 70
- Industry: Pharmaceutical Manufacturing
Key Skills:
- Change Control
- Bending
- Biotechnology
- Deviations
- Document Management
- Electronic Document
- Electronic Document Management System (EDMS)
- End User Training
- Pharmaceuticals
- Regulatory Audits
About the Job:
As a Quality Assurance Associate at Xeris Pharmaceuticals, your primary responsibilities will revolve around the execution of day-to-day quality activities related to the company-wide Quality Management System (QMS). Your key focus areas will include documentation management in the Veeva Electronic Document Management System (EDMS) and document and product change control. Here’s an overview of your key responsibilities:
- Manage GXP Central Filing System: Ensure organized and accessible filing of GXP documentation.
- Provide System Administrator Support: Support Veeva EQMS & EDMS as a System Administrator.
- Facilitate Document Life Cycle: Manage various types of documents through their entire life cycle in EDMS, including SOPs, Batch Records, Protocols, Reports, and Specifications.
- Author and Update Policies: Create and update document control and training policies and procedures as necessary.
- Collaborate for Logical Filing: Work with the business to logically file GXP documentation for easy retrieval.
- Training Support: Assign personnel and training materials to the appropriate Job Roles/curricula in Veeva.
- Quality Control: Support Quality Control data entry processes.
- Document Review and Maintenance: Review, edit, and format documents, monitor document status, and ensure compliance with 21 CFR Part 11.
- QMS Compliance: Ensure timely completion of QMS records and documentation following established policies and procedures.
- Support Cross-Functional Activities: Assist in product change control, complaints, and deviations processes, and provide quality support for initiatives and projects.
- Metrics and Reporting: Generate metrics and trend reports, maintain data, and provide regular updates to Quality Leadership and stakeholders.
- End-User Training: Conduct training for new users of the EDMS and EQMS.
- Customer Service: Interact with internal customers at various management levels to provide excellent customer service.
- Audit Support: Provide support for internal and external/regulatory audits and inspections.
- Other Duties: Perform any other duties as assigned.
Qualifications:
- Education: Bachelor’s degree preferred.
- Experience: Minimum of 1-3 years of experience in a pharmaceutical and/or biotech company.
- Computer Skills: Advanced proficiency in all MS Office products.
- Competencies: Adaptability, Project Management, Problem Solving, Critical Thinking, Self-Starter, Quality-driven, Written & Verbal Communication skills, Organizational skills, Teamwork & Collaboration, Interpersonal skills.
Working Conditions:
- Flexibility: Occasional evening and weekend work may be required, along with periodic overnight travel.
- Physical Requirements: This role includes a mix of office work and physical activities such as walking, standing, bending, kneeling, and more.
About Xeris Pharmaceuticals, Inc.
Quality Assurance Associate jobs in USA
Xeris Pharmaceuticals is a forward-thinking biopharmaceutical company dedicated to improving patients’ lives by developing and commercializing advanced products across various therapies. With a commitment to innovation and quality, Xeris Pharmaceuticals is at the forefront of the pharmaceutical manufacturing industry.
- Website: Xeris Pharmaceuticals
- Industry: Pharmaceutical Manufacturing
- Company Size: 201-500 employees
- Headquarters: Chicago, IL
- Founded: 2005
Don’t miss this opportunity to join a dynamic team and contribute to the advancement of pharmaceutical quality assurance. Apply now and embark on a rewarding career journey with Xeris Pharmaceuticals, where your dedication to quality will make a meaningful impact on patient lives.
For more information and to apply, visit the Xeris Pharmaceuticals Careers Page.
If you’re seeking an entry-level position in the pharmaceutical industry with a focus on quality assurance and document management, Xeris Pharmaceuticals, Inc. in Chicago, Illinois, offers an excellent opportunity. As a Quality Assurance Associate, you’ll have the chance to work in a dynamic environment, contribute to the development of cutting-edge pharmaceutical products, and grow your career. Apply today and be part of a company committed to improving the lives of patients through innovation and excellence.
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