Quality Control Chemist/ Lab Technician/ QC
Intellectt INC5 months ago
El Paso, TX, United States
On-site
Full-time
Junior Level (1-3 years)
Job Description
Job Title: Spec I, Quality Control (QC Chemistry)
Location: El Paso, Texas
Shift: Day Shift
Interview Process: In-Person
Position Summary:
The Quality Control Specialist I is responsible for performing chemical analysis of raw materials, in-process samples, finished products, and stability samples within a pharmaceutical laboratory environment. The role requires hands-on experience with analytical instrumentation including HPLC and GC, adherence to USP/ISO/ASTM testing methods, and compliance with GMP, GLP, and FDA regulations.
Key Responsibilities:
- Perform chemical analysis on raw materials, in-process products, finished goods, and stability samples.
- Operate, maintain, and troubleshoot analytical instruments including HPLC (High-Performance Liquid Chromatography) and GC (Gas Chromatography).
- Conduct testing according to USP, ISO, ASTM, and internal laboratory procedures.
- Maintain Quality Control reports and laboratory documentation.
- Support laboratory housekeeping and safety initiatives.
- Ensure compliance with company policies, GMP, GLP, and safety regulations.
- Maintain laboratory equipment calibration programs and records.
- Develop, validate, and verify chemical testing methods.
- Prepare validation protocols, study reports, and technical documentation.
- Accurately document laboratory activities in notebooks, worksheets, and electronic systems.
- Analyze test data, investigate discrepancies, and troubleshoot laboratory experiments.
- Provide technical support for chemistry laboratory operations.
- Maintain required training certifications and regulatory compliance.
- Support audits, inspections, and quality initiatives.
- Perform additional laboratory duties as assigned.
Required Qualifications:
Education:
- Bachelor's Degree in Chemistry or a related scientific discipline.
Experience:
- Minimum 2 years of hands-on chemistry laboratory experience within a pharmaceutical environment.
- Experience operating and maintaining:
- HPLC
- GC
- Experience performing analytical chemistry testing in a regulated laboratory.
Required Skills:
- Strong knowledge of analytical chemistry principles.
- Hands-on experience with USP, ISO, and ASTM testing methodologies.
- Understanding of chemical method validation and verification.
- Ability to follow detailed laboratory procedures and SOPs.
- Experience maintaining laboratory records and documentation.
- Strong analytical and troubleshooting skills.
- Knowledge of laboratory calibration practices.
- Ability to work independently with minimal supervision.
- Strong organizational and communication skills.
Preferred Qualifications:
- Experience in pharmaceutical quality control laboratories.
- Knowledge of FDA regulations for pharmaceutical products and medical devices.
- Experience working within GMP and GLP environments.
- Familiarity with stability testing programs.
- Experience supporting laboratory audits and regulatory inspections.
Required Skills
USP Testing
Analytical Chemistry
HPLC (High-Performance Liquid Chromatography)
GC (Gas Chromatography)
ISO Standards
GLP Compliance
Troubleshooting Skills
Regulatory Documentation
ASTM Testing
Method Validation
GMP Compliance