Quality Control Technician
Sigma
Quality Control Technician – Bioanalytical / Microbiology | Athens, GA
Sigma Systems is seeking a detail-oriented Quality Control Technician for a 13-month contract opportunity in Athens, Georgia. This role supports Bio Quality Control (Bio QC) testing by performing laboratory assays on raw materials, in-process materials, product release samples, and stability samples in accordance with established procedures and applicable regulatory requirements.
The ideal candidate will have experience with aseptic techniques, microbiological testing, Good Manufacturing Practices (GMP), and laboratory quality control procedures. Candidates with experience in biotechnology, pharmaceutical manufacturing, biologics, veterinary biologics, or other regulated laboratory environments are encouraged to apply.
Key Responsibilities
- Perform bioanalytical and biological quality control testing, including applicable immunological, microbiological, molecular biological, virological, or in vivo assays.
- Conduct laboratory testing on raw materials, in-process samples, product release samples, and stability samples.
- Initiate, execute, and complete laboratory assays in accordance with validated test methods, approved procedures, and established quality standards.
- Ensure laboratory testing activities comply with applicable 9 CFR, EU, and VICH regulatory guidelines, as well as internal quality requirements and production-specific procedures.
- Maintain accurate, complete, and traceable laboratory documentation in accordance with Good Manufacturing Practices (GMP) and applicable documentation standards.
- Communicate testing progress, scheduling constraints, compliance concerns, deviations, and other laboratory issues to supervisors in a timely manner.
- Follow established laboratory procedures and quality systems to support accurate, reliable, and reproducible test results.
- Maintain a safe and organized laboratory environment while adhering to site safety procedures and applicable safety performance indicators.
- Support quality and compliance initiatives by following company policies, laboratory standards, and established operational principles.
- Complete assigned testing activities within required timelines while maintaining data integrity and quality expectations.
Required Qualifications
- Experience or demonstrated familiarity with laboratory quality control testing, preferably in biotechnology, pharmaceutical, biologics, microbiology, or a related laboratory environment.
- Knowledge of aseptic techniques and contamination prevention practices.
- Experience with microbiological testing or other relevant biological laboratory assays.
- Understanding of Good Manufacturing Practices (GMP) and laboratory documentation requirements.
- Ability to follow validated procedures, standard operating procedures (SOPs), and established quality guidelines.
- Strong attention to detail, organizational skills, and commitment to accurate laboratory documentation.
- Effective written and verbal communication skills, including the ability to report testing issues and communicate with supervisors.
- Ability to work safely and consistently in a regulated laboratory environment.
Preferred Qualifications
- Previous experience working in a GMP-regulated laboratory or manufacturing facility.
- Hands-on experience performing microbiological, immunological, molecular biological, or virological assays.
- Familiarity with biological quality control testing for raw materials, in-process materials, product release, or stability samples.
- Exposure to regulatory requirements, including 9 CFR, applicable European Union requirements, and VICH guidelines.
- Experience working with validated analytical methods, controlled documentation, and laboratory quality systems.
- Background in pharmaceutical manufacturing, biotechnology, biologics, or veterinary biologics.
Key Skills & Keywords
- Quality Control (QC) Testing
- Bioanalytical Testing
- Biological Quality Control (Bio QC)
- Aseptic Technique
- Microbiological Testing
- Good Manufacturing Practices (GMP)
- Laboratory Assays
- Standard Operating Procedures (SOPs)
- Validated Test Methods
- Laboratory Documentation
- Raw Material Testing
- In-Process Quality Control
- Product Release Testing
- Stability Testing
- Regulatory Compliance
- 9 CFR, EU and VICH Guidelines
- Contamination Control
- Laboratory Safety
- Data Integrity
- Biotechnology and Biologics
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