Title: Senior Preclinical Quality Assurance AssociateHiring Organization: Connexion Systems & EngineeringCompensation, Benefits, and Employment Type- Duration: Contract / Open-Ended Temporary Assignment
- Pay rate: $35$43/hour
- Job Location: Atlanta, GA
- Work Model: 100% onsite
- Schedule: MondayFriday, 8:30 AM5:30 PM
- Job#: bh19588
Description:A growing life sciences organization in Atlanta, GA is seeking an experienced
Senior Preclinical Quality Assurance Associate to provide quality oversight and support during an extended temporary assignment.
This role is ideal for a seasoned QA professional with
direct experience with 21 CFR Part 58 and GLP/non-GLP preclinical studies. You'll work closely with Quality, Preclinical Study Management, laboratory teams, and internal and external subject matter experts to support compliance, audits, quality systems, and study deliverables.
The team has several upcoming audits and needs someone who can step in quickly and work independently in a fast-paced environment.
What You'll Do- Support Quality Assurance (QA) and Quality Control (QC) activities, including document control, risk management, and CAPA-related activities
- Conduct and participate in internal audits and quality control activities
- Ensure compliance with SOPs, regulatory requirements, and Good Laboratory Practices (GLP)
- Conduct planned audits of facilities and processes and document audit findings in quality systems
- Identify and escalate discrepancies and compliance concerns to management
- Participate in audits of critical phases of GLP studies
- Support quality oversight of preclinical studies and related activities
- Develop and deliver quality training programs for laboratory staff
- Train team members on QA requirements, processes, procedures, and applicable regulations
- Participate in the implementation and monitoring of health, safety, and environmental (HSE) procedures
- Support the quality management system and related implementation activities
- Collaborate with internal and external subject matter experts to facilitate technically sound execution of study deliverables
- Lead quality-related tasks, projects, and deliverables
- Lead internal audits to ensure compliance with applicable standards and requirements
- Prepare, maintain, and update quality documentation
- Train and mentor newer or less experienced team members
- Participate in continuous improvement initiatives focused on quality processes and systems
- Support business development activities as needed, including potential client meetings, client education, and proposal input
What We're Looking ForStrongly preferred:- Direct experience with 21 CFR Part 58
- Direct experience with GLP and non-GLP preclinical studies
- Experience supporting or conducting preclinical quality assurance audits
- Strong understanding of GLP requirements and regulatory policies
- Experience working within a regulated laboratory, preclinical, medical device, pharmaceutical, biotech, or related life sciences environment
Additional Qualifications:- Bachelor's degree in Life Sciences or a related discipline
- Experience working with quality management systems, SOPs, CAPA, document control, and risk management
- Strong audit experience and ability to identify, document, and communicate compliance issues
- Excellent written and verbal communication skills
- Exceptional attention to detail and organizational skills
- Ability to manage multiple projects, priorities, and deadlines
- Ability to work independently with minimal day-to-day guidance
- Strong judgment and problem-solving skills
- Ability to lead and coordinate small cross-functional teams
- Comfortable collaborating with both internal and external stakeholders
- Ability to train and mentor other team members
What You'll Get- $35$43/hour
- MondayFriday, 8:30 AM5:30 PM
- 100% onsite in Atlanta, GA
- Open-ended contract assignment
- Opportunity to work directly with Quality and Preclinical Study Management leadership
- Exposure to active preclinical quality, compliance, and audit initiatives
- Opportunity to contribute to quality systems and continuous improvement efforts
Ideal BackgroundThis position is particularly well suited for a
Preclinical QA professional, GLP Quality Assurance Associate, QA Auditor, or Quality Compliance professional who has hands-on experience with
21 CFR Part 58 and GLP/non-GLP preclinical research.
If you have direct preclinical QA experience and are comfortable stepping into a fast-moving environment with upcoming audits and multiple competing priorities, we'd like to hear from you.
Please use the apply button to submit your resume for consideration. You will receive a brief survey via email to complete your application. Applicants who complete the survey will receive priority consideration.You can review our other job postings athttps://jobs.csetalent.com/.If you are active in a job search but this job is not for you, please reach out to jobpostings@csetalent.com
. We would be glad to help you find the perfect job!Connexions mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.