Quality Specialist
$25/h-$30/h
a day ago
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OnsiteFull-timeMid
Summary
Certified Group is seeking a Quality Specialist to join their team in Carrollton, TX. The role involves ensuring compliance with FDA regulations and managing electronic Quality Management Systems (eQMS) within the biotechnology research industry.
About the Role
As a Quality Specialist, you will be responsible for implementing and maintaining the eQMS, leading CAPA processes, handling customer complaints and OOS investigations, conducting internal audits, and collaborating with cross-functional teams to uphold quality standards. You will also develop quality-related documentation and assist in regulatory inspections.
About You
Required:
- Bachelor's degree in a scientific or technical field, such as Chemistry, Biology, Engineering, or related discipline.
- 3-5 years of experience in a quality assurance role within an FDA regulated industry, preferably in pharmaceuticals, medical devices, or biotechnology.
- Strong understanding of FDA regulations and guidelines, including cGMP, 21 CFR Part 11, and ICH guidelines.
- Proven experience in managing electronic Quality Management Systems (eQMS).
- Proficiency in conducting investigations, root cause analysis, and implementing corrective actions for CAPA, Customer Complaints, and OOS events.
- Experience in conducting Internal Audits.
Preferred:
- Familiarity with audit processes and methodologies.
- Excellent communication skills and ability to collaborate with cross-functional teams.
- Strong attention to detail and analytical skills.
- Ability to work independently and manage multiple projects in a fast-paced environment.
Benefits
- Progressive 401k Retirement Savings Plan
- Employer Paid Short- Term and Long-Term Disability, and Life Insurance
- Group Medical
- Tuition Reimbursement
- Flexible Spending Accounts
- Dental
- Paid Holidays and Time Off
- Many positions which qualify for the company bonus program
Certified Group
Certified Group partners with customers to deliver innovative scientific solutions and expertise – So The World Can Trust In What It Consumes™. Our network of 30+ North American and European laboratories serves the food & beverage, dietary supplements, cosmetics, OTC, tobacco/nicotine, cannabis, and hemp industries. Certified Group includes Food Safety Net Services (FSNS), FSNS Certification & Audit, Certified Laboratories, EAS Consulting Group, and Labstat International Inc.
Carrollton, TX