8048 QC Analyst II
Perform chemical testing in support of manufacturing operations, lot release and validation in accordance with standard operating procedures.
Collect, process, and report data.
Apply knowledge of good manufacturing practices and good laboratory practices on a daily basis.
Conduct routine and non-routine analysis of manufactured products.
Calibrate and maintain laboratory and instrumentation equipment.
Revise and update standard operating procedures.
Troubleshoot testing methods.
Maintain laboratories in audit ready and cGMP compliant manner.
Compile data for documentation of test procedures and prepare reports.
Review and evaluate data for conformance to specifications/reports.
Investigate anomalous data. Provide ongoing training and process improvements.
Prepare reagents for laboratory testing.
Perform compliance walks and complete routine cleaning and maintenance of lab equipment.
Experience in LIMS and Empower preferred.
Initiate, compile, and/or support lab investigations including reviewing documents, conducting internal and external interviews, and compiling data.
Ability to troubleshoot assay and instrument issues.
Perform chemical testing at all levels of complexity to support manufactured products, investigations, special studies, and validation activities.
Train others in basic to complex laboratory techniques.
Serve as a liaison for daily activities and special projects within QC or cross-functionally.
Act as subject matter expert for assays/areas of technical expertise and provide support to analysts within department and cross-site.
Participate in routine projects.
Responsible for working independently as well as within a team.
Responsible for collecting, entering data and generating reports from electronic systems.
Identify and train in other applications or assays as necessary to support QC activities as a subject matter expert.
Identify functional improvement needs for laboratory systems or technical equipment.
Support projects requiring technical or project management guidance.
Apply theories and principles from technical and/or professional discipline to independently address a variety of problems of moderate scope.
All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).
Ensures the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one’s functional area. Fosters a positive safety culture in which no one gets hurt.
Demonstrate excellent organizational skills.
Strong written and verbal communication skills, with demonstrated leadership in a large group. Computer skills- Microsoft Word, Excel, Power Point.
Ability to read and follow Standard Operating Procedures.
Work under general supervision and guidance.
Ability to read and interpret technical data.
Ability to work in a fast pace environment with high volume testing schedules.
Experience in testing chemical assays.
Excellent aseptic technique.
Experience with electronic systems used in laboratories – LIMS, Empower.
Knowledge of laboratory safety procedures.
Experience working in GMP environment.
Experience speaking to auditors.
Work Environment/Physical Demands/Safety Considerations:
Work in office and laboratory environment.
Lift up to 30lbs.
May work in the clean room environment that requires gowning and no makeup or jewelry.
May work in the clean room environment where it is loud due to different equipment operating.
Work with some hazardous materials and chemicals.
Ability to sit, stand and move within work space for extended periods.
Ability to perform repetitive tasks including frequent hand to finger manipulations, grasping, pushing and pulling.
Ability to stand 8 to 10 hours a day.
Education: Education and Experience
Bachelor’s Degree in Biology, Microbiology, Biochemistry, Chemistry or other relevant discipline.
5-6 years of related experience.