Quality Control Associate Specialist
2 weeks ago
Position: Quality Control Associate Specialist
Compensation: Competitive hourly rate
Contract Duration: 1 year with potential for extension
Essential Qualifications:
- Proficient in HPLC and/or Capillary Electrophoresis methodologies
- Strong adherence to regulatory standards, established protocols, and safety measures
- Adaptability to shifting priorities and requirements
Role Summary:
This position operates under general oversight, tasked with executing analytical evaluations and providing support within the HPLC/Capillary Electrophoresis division of Clinical Quality Control. The Quality Control Associate Specialist will assist the QC analytical biochemistry team by conducting tests involving HPLC/UHPLC (high and ultra-high liquid chromatography), titer, CE (capillary electrophoresis), CEX (cation exchange), and HILIC (hydrophilic interaction). Additional testing responsibilities may include TOC (total organic carbon), LAL (endotoxin testing), protein concentration, appearance, and pH.
Key Responsibilities:
- Engage in various QC activities, including analytical assessments, sample and data management, and equipment upkeep.
- Conduct routine laboratory procedures such as sample evaluations and preparation of standards and solutions.
- Document, compile, interpret, review, and input laboratory data accurately.
- Communicate results effectively, maintain and operate specialized equipment, and draft/revise documents like Analytical Methods, SOPs, and technical reports.
- Assist in the integration of new methodologies and techniques into the laboratory environment.
- Perform basic troubleshooting for assays and instruments.
- Identify, suggest, and implement enhancements related to standard job functions.
- Comply with safety protocols and basic cGMP regulations.
- Exhibit flexibility in work schedules as necessary.
- Be available for on-call duties as required.
Preferred Qualifications:
- Bachelor's degree with a minimum of 2 years of GMP experience is preferred.
- Experience with HPLC/UPLC and/or Capillary Electrophoresis techniques.
- Background in GMP Chemistry or Biology.
- Strong ability to adhere to regulatory standards, established protocols, and safety measures.
- Capability to evaluate documentation/data in accordance with company and regulatory standards.
- Excellent organizational skills to manage multiple priorities and meet deadlines.
- Strong written and verbal communication abilities.
- Detail-oriented with a flexible approach to changing priorities and requirements.
- Understanding of regulatory requirements, safety protocols, and compliance factors.
- Ability to recognize when and how to escalate issues appropriately.
- Proficient in software applications such as Teams, Excel, and Word.
- Familiarity with SharePoint, Smart Sheets, or LIMS is advantageous.
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