Conduct routine and non-routine analysis of manufacturing environment and in process commercial products according to standard operating procedures. Responsible for collecting, processing and reporting data. Apply knowledge of good manufacturing practices and good laboratory practices on a daily basis. Compile data for documentation of test procedures and prepare reports for internal and regulatory submissions. Calibrate and maintain laboratory and instrumentation equipment. Develop and/or optimize testing methods and troubleshoot testing methods. Revise and update standard operation procedures. Review and evaluate data for conformance to specifications and report and investigate anomalous data. Ensure quality and safety of manufactured products. Use state-of-the-art techniques to evaluate and implement new techniques and technologies.
Proficient in cGMP practices in all aspects of laboratory assignments
Perform routine testing and basic troubleshooting
Represent QC and serve as a point of contact for manufacturing and other departments
Perform microbiological and chemical assays according to established procedures
Share responsibilities with a team to accomplish all testing needed for QC samples
Participate in routine projects
Assist in data trending, data review, lab maintenance, training of new personnel
Collect data, enter data and generate reports from electronic systems.
Initiate, compile, and perform lab investigations that include reviewing documents, conducting internal and external interviews, and tracking information.
All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).
Follows established safety and environmental guidelines and procedures for all work performed. Immediately reports safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions. Fosters a positive safety culture in which no one gets hurt.
Attend team, department and corporate meetings as required
Attend seminars and/or classes as necessary to support business demand
Knowledge, Skills, and Abilities
Demonstrate excellent organizational skills
Ability to read and follow Standard Operating Procedures
Excellent interpersonal, written and verbal communication skills
Ability to read and interpret technical data
Proficient with QC systems
Must have working knowledge in manual and automated chemical and microbiological assays
Must be able work independently as well as within a team in a fast pace environment
Product Quality Assurance
Troubleshooting (Problem Solving)
Complex Problem Solving