QC Tech II - 1st Shift

Work Schedule

First Shift (Days)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Fluctuating Temps hot/cold, Laboratory Setting, Loud Noises (Equipment/Machinery), No contact lens allowed; prescriptive glasses will be provided, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

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.

Key Responsibilities:

Laboratory Operations:

• Demonstrating 4 I’s (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: Associate's or Bachelor's degree in a scientific discipline (e.g., Biology, Chemistry, Biochemistry) or equivalent experience.
• Experience: Minimum of 2 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.