Quality Systems Specialist I
Req ID #: 215904
Memphis, Tennessee, USA
What you’ll do
Quality Systems Specialist I will report to the manager in the Quality Systems organization, which manages oversite of GMP systems such as deviations, CAPA, Change control, and OOSs. You will support the site’s execution of and compliance to GMP, GDP, and FDA requirements by maintaining QMS data and overseeing the quality of regulatory documentation
The essential duties/responsibilities include:
- Support and drive on time completion of investigations, CAPAs, Change controls, etc by closing out QMS documentation following GDP practices
- Participate in projects within the department as assigned by management
- Support Quality Systems processes and assist plant wide departments with quality systems process (e.g. Investigations, CAPA, Change Control, etc)
- Revise Standard Operating Procedures as assigned by management
- Develop and use quality and critical thinking skills
- Participate in continuous improvement projects
- Develop understanding of manufacturing processes and quality systems elements
- Communicate with other managers for process improvements and quality concept
- Have excellent written and verbal communication skills
- Perform other duties as assigned
What you’ll need
- Bachelor’s Degree in life sciences or related field is required
- 0-2 years in GMP related experience in biopharmaceutical/pharmaceutical or related industry
- Experience with GMP regulatory requirements.
- Organized with paperwork
- Detailed oriented
What you get
Core Benefits
- Mental/Dental/Vision Plans
- Vacation and Holiday
- 401(k) with Company Match
- Employee Stock Purchase Plan
Value Added Programs
- Employee discount program
- Tuition Reimbursement
- Employee Recognition and Referral Program
Additional Benefits
- Employee Assistance Plan
- Fitness Reimbursement and Wellness Programs
- Paid Volunteer Time Off
- Parental Leave
About Charles River
Charles River is an early-stage Contact Research Organization (CRO). Here, we are passionate about our role in improving the quality of people's lives. With 100 sites around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our clients' unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world.
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