This position is 2nd Shift
The Quality Control Laboratory Technician I is responsible for:
· Performing, documenting and reporting Quality Control Laboratory testing and procedures
· Providing technical support for the Quality Control Department to ensure effective operations
· Packaging seal tests, product moisture and mechanical strength tests, environmental monitoring of clean rooms, data entry, and any other required laboratory testing
· Follow SOP's to perform Quality Control Laboratory testing and inspection. Operate standard laboratory equipment for water content determination, mechanical strength testing, balances, microscope, UV, UPLC, and packaging seal etc, laboratory testing.
· Perform Environmental Monitoring (EM) of non-sterile manufacturing operations facility, including but not limited to: non-viable and viable Air particulate and viable surface sampling etc.
· Preparation of reagents and solutions in support of laboratory testing and/or environmental monitoring.
· Sample and test USP purified water serving manufacturing facility and laboratories
· Ensure appropriate levels of supplies and equipment; Perform data entry for appropriate Quality and Oracle databases;
· Initiate and conduct Out of Specification (OOS) and Environmental Over-Action Limit investigations
· Conduct inventory of laboratory testing supplies/media and place orders accordingly.
· Comply with current Good Laboratory and Good Documentation Practices. Maintain appropriate databases and spreadsheets to accurately report and trend test results
· Ensure that records and raw data are properly recorded, reviewed, and retained. Summarizes, interprets, reviews laboratory data, and draw conclusions.
· Participate in compliance program-related activities. Support LifeCell's overall Quality Systems by understanding and acting on departmental and project objectives
· Collect test samples. Ensure dispose of solutions and media as per SOPs. Manage and monitor preventive maintenance and calibration activities of lab equipment. Maintain safe laboratory working environment.
· Provide timely support to R&D, manufacture, etc. cross functional teams.
· Develop, review and revise laboratory Standard Operating Procedures. Write study protocols, reports, test procedures etc. Compile data and prepare quarterly and annual summary reports.
· Maintain GMP readiness of laboratories by performing internal audits. Sustain 6S and keep laboratory a safe and pleasant working environment.
· Perform UPLC and UV analysis in support of R&D, production and product release testing as needed
· Support the overall Quality System program at LifeCell
Position Qualification Requirements
· Associates degree in Microbiology, Chemistry, or related field
· At least 1 year experience in quality control laboratory environment
· Experience with MS Office applications including Word, Excel, & Outlook
Other Position Qualifications
In addition to the basic qualifications listed above, the following other position qualifications are required:
· Experience with maintaining and ensuring proper operation of laboratory equipment and workstations
· Experience with following SOPs in performing Quality Control testing for product release and evaluation of R&D samples
· Experience with cGMP's
· Experience in FDA and USP regulations/guidelines.
· Experience working with internal and external customers. I.e. Vendors, collaborating investigators, testing labs etc.
· Demonstrated ability to meet all performance aspects of the job including: following work instructions, meeting attendance standards, meeting safety standards and comprehending standard operating procedures.
· Demonstrated project management and technical writing skills
· Demonstrated presentation and communications skills
In addition to the basic qualifications and other required qualifications listed above, the following preferred qualifications also exist:
· Bachelors degree in Microbiology, Chemistry, or related field
· Experience with Trackwise, Oracle, MS Project
· Experience with standard microbiology laboratory equipment, i.e. autoclave, incubators, microscope, RiboPrinter, LAL readers, etc.
· Experience with Endotoxin, Bioburden, and Dose Audits for Sterility testing
· Experience with HPLC assay and purity analysis
The information listed in this Job Description is not a comprehensive list of all duties/responsibilities performed.
This Job Description is not an employment agreement or contract. Management has the exclusive right to alter this position guide at any time without notice.
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