QC Sterile Laboratory Technician I
About The Position
Provide support to Production by visually inspecting sterilized glass vials throughout daily activities; identify and classify defects Perform visual inspection and testing of incoming materials using statistical sampling techniques, precision measuring instrumentation and FT-IR to ensure conformance Perform laboratory tests including endotoxin, bioburden and sub visible particle Perform Environmental Monitoring in ISO level Clean Room including compressed air testing Conduct inventory of laboratory supplies and communication needs for order placement(s) Collect WFI (Water For Injection) for testing using aseptic technique Communicate non-conforming issues and interact effectively with proper contact(s) Demonstrate flexibility in providing coverage during instances of co-work vacation time and/or medical absence(s) Cross train in other areas and/or functions of the laboratory to support business needs Complete daily, weekly and monthly cleaning of applicable laboratory areas Review testing documents for completeness and accuracy Maintain all laboratory notebooks and equipment log books Work on all assigned tasks, projects and daily tasks Follow all Company policies and procedures Participate in required trainings and meetings, when necessary Help promote and implement safety/EHS directives and maintain a clean and safe workspace Follow cGMP and adhere to all ISO and safety guidelines and policies
Requirements
- High School Diploma or GED, required
- Basic computer knowledge and skills including MS Office
- Multi-tasking abilities
- Detail oriented approach; ability to follow directions and instructions
- Positive team approach
- Effective communication skills
- Ability to read, write and speak English language
Nice To Haves
- Quality Control and laboratory experience, preferred
- Experience working in a fast-paced manufacturing setting
- Understanding of cGMP and ISO, preferred
Responsibilities
- Provide support to Production by visually inspecting sterilized glass vials throughout daily activities; identify and classify defects
- Perform visual inspection and testing of incoming materials using statistical sampling techniques, precision measuring instrumentation and FT-IR to ensure conformance
- Perform laboratory tests including endotoxin, bioburden and sub visible particle
- Perform Environmental Monitoring in ISO level Clean Room including compressed air testing
- Conduct inventory of laboratory supplies and communication needs for order placement(s)
- Collect WFI (Water For Injection) for testing using aseptic technique
- Communicate non-conforming issues and interact effectively with proper contact(s)
- Demonstrate flexibility in providing coverage during instances of co-work vacation time and/or medical absence(s)
- Cross train in other areas and/or functions of the laboratory to support business needs
- Complete daily, weekly and monthly cleaning of applicable laboratory areas
- Review testing documents for completeness and accuracy
- Maintain all laboratory notebooks and equipment log books
- Work on all assigned tasks, projects and daily tasks
- Follow all Company policies and procedures
- Participate in required trainings and meetings, when necessary
- Help promote and implement safety/EHS directives and maintain a clean and safe workspace
- Follow cGMP and adhere to all ISO and safety guidelines and policies
Benefits
- Excellent healthcare benefits including medical, dental and vision
- Short and long term disability
- Tuition reimbursement
- Paid time off
- Pet insurance
- Other supplemental benefits available upon election
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
