We are seeking an experienced Senior Quality Control Specialist to join our Quality Control Operations team in Social Circle, GA. This position serves as a technical leader within QC Operations Support, driving quality systems excellence, analytical method implementation, compliance initiatives, and continuous improvement activities in a regulated pharmaceutical manufacturing environment.
The ideal candidate will possess strong Quality Control experience, preferably within QC Microbiology, and demonstrate expertise in cGMP regulations, laboratory operations, quality systems, and cross-functional project leadership.
Key Responsibilities
- Perform and support Compendial Assessments for laboratory testing and quality processes.
- Author, review, and approve technical documents, procedures, protocols, and reports.
- Design, coordinate, and support analytical method onboarding and implementation activities.
- Lead qualification activities for critical materials, laboratory instruments, and equipment.
- Manage and oversee Change Control processes and associated documentation.
- Drive Corrective and Preventive Actions (CAPAs) from initiation through closure.
- Serve as a Subject Matter Expert (SME) for QC systems, compliance, and laboratory operations.
- Collaborate effectively with Manufacturing, Quality Assurance, Regulatory Affairs, Validation, and other cross-functional teams.
- Identify and implement continuous improvement opportunities within QC operations.
- Conduct data trending, statistical analysis, and performance monitoring to support quality objectives.
- Represent Quality Control on local and global projects, audits, and regulatory inspections.
- Support additional quality and operational initiatives as assigned by leadership.
Required Qualifications
- Bachelor’s degree in Science, Engineering, Microbiology, Chemistry, Biology, or a related technical discipline.
- Minimum 5–7 years of Quality Control experience within the pharmaceutical, biotechnology, medical device, or other regulated industry.
- Strong experience with QC laboratory operations and quality systems.
- Experience working within cGMP-regulated environments.
- Knowledge of government regulations related to pharmaceutical and medical device manufacturing laboratories.
- Experience managing investigations, deviations, CAPAs, change controls, and quality documentation.
Preferred Qualifications
- Strong QC Microbiology experience, including testing, sampling, and laboratory processes.
- Experience supporting analytical method transfers, validations, and onboarding activities.
- Advanced understanding of statistical analysis and quality metrics.
- Experience leading projects, mentoring teams, and driving operational excellence initiatives.