Team Leader, QC
$31,200–$31,200 year
On-siteFrederick, Maryland, United States
Job Summary
Lead and develop the Genexus QC weekend shift team while performing hands-on quality control testing of reagents and kits using next-generation sequencing and purification methods. Oversee Out of Specification investigations, manage problem reporting through TrackWise, and update testing methods and SOPs to ensure data integrity and compliance. Perform peer reviews of QC data packets, support method validation activities, and ensure the laboratory adheres to cGMP requirements and safe working practices. Manage weekend shift operations to support continuous manufacturing needs while fostering a team-first mindset and promoting the 4 I values.
Required Qualifications
- Bachelor's Degree
- 2 years of experience in pharmaceutical/biotech QC laboratory operations
- Knowledge of GMP regulations
- Knowledge of ICH guidelines
- Knowledge of pharmacopeia standards
- Strong technical proficiency with analytical instrumentation and testing methods
- Experience with laboratory information management systems (LIMS)
- Experience with quality documentation
- Demonstrated success implementing process improvements
- Troubleshooting investigations
- Excellent project management and organizational skills
- Strong interpersonal abilities to lead teams
- Collaborate across functions
- Clear written and verbal communication skills
- Technical writing
- Proficiency with Microsoft Office suite
- Statistical analysis tools
- Ability to work a fixed weekend schedule
- Strong attention to detail
- Commitment to data integrity
- Experience managing lab equipment
- Calibration
- Maintenance programs
- Knowledge of environmental monitoring
- Contamination control
- Demonstrated problem-solving abilities in a structured environment
- English proficiency
Desired Qualifications
- 1+ years of supervisory experience
- Preferred Fields of Study: Chemistry
- Preferred Fields of Study: Biology
- Preferred Fields of Study: Biotechnology
- Preferred Fields of Study: Pharmaceutical Sciences
- Preferred Fields of Study: related scientific field
- 1-2 years demonstrated leadership experience managing technical teams
- Industry certifications in GMP/GDP practices
- Additional languages
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