Qc Chemistry Technician

2 weeks ago

Toronto, Canada PSC Biotech Full time

***:
The QC Chemistry Technician handles testing materials and finished products to ensure they conform to all applicable laws and company standards. The QC Chemistry Technician will test products across all stages of production to ensure quality levels are met.
- **This position is on-site in York, PA.**

**DUTIES AND RESPONSIBILITIES**:

- Batch record reviews of QC Chemistry tests for clinical trial material, method validation protocol and SOP development, method validation execution, perform analytical chemistry tests in a QC lab, analytical chemistry equipment validation support
- Assure proper qualification, maintenance and calibration of lab equipment and on-line test instruments
- Provide complex statistical analysis of data using Six Sigma methodologies
- Verify and certify all data uploaded to labware and TRS (finished goods, raw materials and non-production samples) each day
- Ensure all data is complete and approve data defensible files for all OOC/OOS data
- Ensure the lab maintains all logbooks, check lists, SPC and tune file tracking documents
- Participate in and support CAPA Review Board meetings, including follow up actions
- Other duties as assigned

**Requirements**:

- A minimum of a BS degree in chemistry, physics or engineering required.
- General lab instrument (HPLC, IC, GC, ICP-MS, ICP-AES) operations and maintenance experience preferred, ICP-MS experience strongly preferred
- 3 - 4 years of related experience or training preferred
- Experience with applicable quality tools such as Pareto, FMEA’s, SPC/SQC, histograms, trend analysis, process mapping, design of experiments, cause and effect diagrams, 8D problem solving methodology
- Basic computer knowledge, including MS Office; LIMS experience preferred
- Knowledge of proper safe handling/disposal of chemicals and ability to maintain a clean and safe workspace
- Strong independent operation skills and ability to complete lab work safely
- Proven ability to partner with leadership to determine training needs, and develop training for cross-functional personnel

LI-TW1

A minimum of a BS degree in chemistry, physics or engineering required. General lab instrument (HPLC, IC, GC, ICP-MS, ICP-AES) operations and maintenance experience preferred, ICP-MS experience strongly preferred 3 - 4 years of related experience or training preferred Experience with applicable quality tools such as Pareto, FMEA’s, SPC/SQC, histograms, trend analysis, process mapping, design of experiments, cause and effect diagrams, 8D problem solving methodology Basic computer knowledge, including MS Office; LIMS experience preferred Knowledge of proper safe handling/disposal of chemicals and ability to maintain a clean and safe workspace Strong independent operation skills and ability to complete lab work safely Proven ability to partner with leadership to determine training needs, and develop training for cross-functional personnel #LI-TW1

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