QC Technician II 1st Shift
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Job Location:
Middletown, DE - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Work Schedule
First Shift (Days)Environmental Conditions
Able to lift 40 lbs. without assistance Adherence to all Good Manufacturing Practices (GMP) Safety Standards Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.) Strong Odors (chemical lubricants biological products etc.) Will work with hazardous/toxic materialsJob Description
Quality Control Technician II is responsible for performing a variety of tasks to ensure the quality and integrity of products and processes within the laboratory. This role involves executing and reporting test results troubleshooting instruments and participating in validation processes. QC Technician II will also assist in training new hires and contribute to process improvements within the QC lab environment.
Hours: Mon-Fri. 7a-3:30pm EST
Key Responsibilities:
Laboratory Operations:
- Demonstrating 4 Is (Integrity Intensity Innovation and Involvement)
- Conducting instrument daily start-ups and maintaining logbooks
- Proficiency with basic lab techniques such as pipetting and serial dilutions
- Understanding instrument operations and quality processes (SOPs Inspection Plans Test Methods)
- Sample preparation and QC buffer solutions
- Managing inventory and bench stocking
- Performing daily and weekly housekeeping
- Data entry
Testing and Reporting:
- Conduct tests and accurately report results.
- Evaluate results and understand the scientific reasoning and rationale behind data generation.
- Detect quality incidents in the lab and provide effective feedback to drive the progress of Out of Specification (OOS) investigations.
Instrument and Process Management:
- Troubleshoot and resolve instrument issues.
- Review stability data and ensure compliance with testing documentation per cGMP and GLP standards.
- Participate in the execution of validation processes with minimal guidance.
Training and Development:
- Assist in cross-training and training new hires.
- Develop and apply prioritization skills to manage workload effectively.
- Continue enhancing proficiency in the use and application of moderate lab procedures.
Process Improvement:
- Adopt and apply basic Practical Process Improvement (PPI) principles to enhance the QC lab environment.
- Contribute to continuous improvement initiatives and support the implementation of best practices.
Qualifications:
- Education:HS Diploma or Equivalent
- Experience:Minimum of 1 years of experience in a Quality Control laboratory or related field.
- Skills:
- Strong understanding of laboratory techniques and quality processes.
- Proficiency in data analysis and scientific reasoning.
- Ability to troubleshoot and resolve instrument issues.
- Excellent communication and interpersonal skills.
- Strong organizational and prioritization skills.
- Familiarity with cGMP and GLP standards.
- Demonstrated ability to train and mentor junior staff.
Working Conditions:
- This position may require standing for extended periods and handling hazardous materials.
- Must be able to work in a laboratory environment with exposure to chemicals and biological materials.
Required Experience:
IC
Key Skills
- Laboratory Experience
- Aseptic Technique
- ELISA
- FDA Regulations
- PCR
- High-Performance Liquid Chromatography
- Microbiology
- Quality Control
- GLP
- cGMP
- Laboratory Information Management Systems
- QA/QC
About Company
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