Job Description
Job Summary:
- The purpose of the Microbiology Lab Tech I role is to conduct analytical testing on commercial, stability and non-routine samples.
- They are responsible for ensuring that all testing is carried out in accordance with cGMP.
Key Responsibilities:
- Primary Commitment to patient safety and product Quality.
- Understands and comply with all the regulations governing the quality systems.
- Delivery of key Quality and Performance Objectives.
- Ensure that you are in compliance with all mandatory training requirements.
- Your responsibilities will include, raw material, in process and finished product testing.
- Complete documentation associated with analytical testing in a timely manner.
- Ensure all analytical testing is carried out as defined in the Quality System.
- Provide analytical support to process validations.
- Participate in Regulatory, Internal and Vendor audit programs as required.
- Provide training, technical guidance / trouble shooting to junior laboratory staff.
- Review of Laboratory results and documentation.
- Perform and assist with additional duties as may be directed by the QC supervisor.
Quality Systems Duties and Responsibilities:
- Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
Education:
- AA Degree or equivalent work experience in related discipline.
- A degree in a non-science category can be considered.
3 Top Lab Skills:
- Some Endotoxin testing experience.
- Bioburden testing experience.
- Familiarity with Graduated cylinder, tinsnips, scissors, taking measurements.
Additional Skills Required:
- Must be willing to learn.
- Must have superior attention to detail.
Work Environment:
- There are approximately 18 people in department.
- Half the team may be working in lab on any given day.
- This is an office + lab environment.