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Senior Pharmaceutical Quality Specialist
3 weeks ago
Job Overview:
The Quality Control (QC) Analyst is responsible for ensuring the quality of pharmaceutical substances in a Good Manufacturing Practice (GMP) environment. This role involves performing testing and analysis using various techniques, including Gas Chromatography (GC) and High-Performance Liquid Chromatography (HPLC). The successful candidate will have excellent analytical skills, attention to detail, and the ability to work independently.
Key Responsibilities:
- Perform testing and analysis of pharmaceutical substances, raw materials, and drug substances in a GMP environment.
- Conduct GC and HPLC analysis, as well as other analytical techniques as required.
- Train on relevant analytical techniques and train other analysts upon qualification.
- Maintain laboratory equipment and calibrate regularly.
- Manage inventory and materials for analysis.
- Verify and review results from other analysts when qualified.
- Ensure accurate data entry into Laboratory Information Management Systems (LIMS).
- Assess testing results and close out batch analyses.
- Meet target dates and update testing status.
- Maintain high standards of laboratory housekeeping.
- Document work accurately.
- Work collaboratively to meet customer expectations and Key Performance Indicators (KPIs).
Requirements:
- High school diploma or equivalent required; bachelor's degree in chemistry, biology, or related field preferred.
- 1+ year experience in QC analysis or related field.
- Excellent analytical skills and attention to detail.
- Ability to work independently and as part of a team.
- Strong communication and documentation skills.