Quality Control Associate I
About The Position
We are seeking a QC Associate to support direct material (raw material) testing. As a Quality Control Associate I, you will be responsible for compendial method testing, direct material (raw material), reagent preparation, and sample management for biopharmaceutical products. Additional responsibilities include equipment management and maintenance, and laboratory duties. The Opportunity Compliance and Quality System Adherence: Apply advanced knowledge of GMP, GDP, and Data Integrity ALCOA principles daily. Follow established safety and environmental guidelines and maintain the laboratory in an inspection-ready state (e.g.,5S implementation). Core Compendial Testing: Execute and document routine and non-routine compendial testing, including pH, osmolality, Karl Fischer, basic wet chemistry, and other general techniques according to established procedures. Chemical Assay Execution: Perform specialized chemical assays and analysis, collect and process data, and ensure results are reported accurately and on time. Equipment Maintenance and Readiness: Perform daily and periodic laboratory equipment maintenance, including calibration and standardization of equipment, to ensure continuous readiness and compliance. Technical Support and Troubleshooting: Perform basic troubleshooting of chemical assays and provide initial support for instrument issues to minimize downtime. Materials and Inventory Management: Perform sample management and aliquoting. Manage laboratory supplies by performing inventory checks and stocking supplies as needed (e.g., preparing reagents). Investigation and Data Review: Assist in data trending and data review for conformance to specifications. Assist with or lead laboratory investigations OOS/OOT with appropriate oversight. Training and Cross-Functional Liaison: Train others in basic to complex laboratory and troubleshooting techniques. Serve as a liaison for daily activities and special projects within QC or cross-functionally. Independent Execution: Demonstrate the ability to work independently with little supervision and provide support for the execution of studies and protocols as needed
Requirements
- Bachelor’s degree in Chemistry, Biochemistry, or a related scientific discipline
- 3-4 years of experience in pharmaceutical/biotech QC labs
- Hands-on raw material testing under cGMP
- Basic knowledge in Chromatography and chemical testing assays
- Basic equipment troubleshooting techniques
- Proficiency in all necessary wet chemistry methods
- Experience working in a GMP environment
- Ability to read and follow Standard Operating Procedures precisely
- Knowledge of laboratory safety procedures
- Basic experience supporting quality events
- Proficiency with laboratory electronic systems, including LIMS and Microsoft Office
- Excellent organizational skills
- Ability to be agile and work independently in a fast-paced environment
- Experience working on group projects
- Proficient in time management with oversight
- Excellent interpersonal, written, and verbal communication skills
- Continuous improvement mindset
- Basic experience supporting audit or inspection activities
Nice To Haves
- Working knowledge of Empower or GSMP software
Responsibilities
- Apply advanced knowledge of GMP, GDP, and Data Integrity ALCOA principles daily.
- Follow established safety and environmental guidelines and maintain the laboratory in an inspection-ready state.
- Execute and document routine and non-routine compendial testing, including pH, osmolality, Karl Fischer, basic wet chemistry, and other general techniques according to established procedures.
- Perform specialized chemical assays and analysis, collect and process data, and ensure results are reported accurately and on time.
- Perform daily and periodic laboratory equipment maintenance, including calibration and standardization of equipment.
- Perform basic troubleshooting of chemical assays and provide initial support for instrument issues.
- Perform sample management and aliquoting.
- Manage laboratory supplies by performing inventory checks and stocking supplies as needed.
- Assist in data trending and data review for conformance to specifications.
- Assist with or lead laboratory investigations OOS/OOT with appropriate oversight.
- Train others in basic to complex laboratory and troubleshooting techniques.
- Serve as a liaison for daily activities and special projects within QC or cross-functionally.
- Demonstrate the ability to work independently with little supervision and provide support for the execution of studies and protocols as needed.
Benefits
- Discretionary annual bonus may be available based on individual and Company performance.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
