More jobs:
Quality System Specialist II
Job in
Hercules, Contra Costa County, California, 94547, USA
Listed on 2026-07-18
Listing for:
Manpower
Full Time
position Listed on 2026-07-18
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, Data Analyst
Job Description & How to Apply Below
Quality System Specialist II
Our client, a leader in the life sciences and regulated manufacturing industry, is seeking a dedicated and detail-oriented Quality System Specialist II to join their team. As a Quality System Specialist II, you will be an integral part of the Quality Assurance department supporting various compliance and continuous improvement initiatives. The ideal candidate will demonstrate strong organizational skills, excellent communication abilities, and a proactive approach to problem-solving, which will align successfully in the organization.
Location:
Hercules, CA
Shift: Day
What's the Job?
- Support the administration and maintenance of the Quality Management System (QMS) to ensure compliance with regulatory standards.
- Review, process, and maintain controlled documents such as SOPs, work instructions, forms, and records.
- Assist with document change requests, revision control, and support investigations, deviations, CAPAs, and change control activities.
- Monitor quality system metrics and generate reports to support continuous improvement efforts.
- Assist with internal and external audits, including preparation and follow-up activities, ensuring documentation compliance.
What's Needed?
- Bachelor's degree in Biology, Chemistry, Engineering, Life Sciences, or a related field, or equivalent experience.
- At least 2 years of experience supporting Quality Systems, Quality Assurance, or Quality Compliance in a regulated environment.
- Working knowledge of Quality Management Systems (QMS) and familiarity with FDA Quality System Regulations (21 CFR Part 820), ISO 13485, or other standards.
- Strong organizational skills with exceptional attention to detail and excellent written and verbal communication skills.
- Proficiency with Microsoft Office Suite (Word, Excel, Outlook, PowerPoint).
What's in it for me?
- Opportunity to contribute to a reputable organization committed to quality and compliance.
- Engage in meaningful work supporting regulatory and quality assurance activities.
- Collaborate with cross-functional teams in a dynamic environment.
- Develop your skills and expertise within the life sciences industry.
- Be part of a company that values diversity and inclusion, fostering a supportive workplace culture.
Upon completion of waiting period associates are eligible for:
- Medical and Prescription Drug Plans
- Dental Plan
- Supplemental Life Insurance
- Short Term Disability Insurance
- 401(k)
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