3080 QC Analyst II
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.
Skills: 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 cGMP experience.
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.
Education and Experience
Bachelor’s Degree in Biology, Microbiology, Biochemistry, Chemistry or other relevant discipline and 1 year of related experience or AA and 4 years of related experience or HS and 6 years of related experience.
Work Environment/Physical Demands/Safety Considerations
Work in office and laboratory environment.
Ability to stand for 8 to 10 hours a day.
Ability to lift up to 30lbs.
Ability to climb upwards of 6 flights of stairs a day to maneuver within the manufacturing facility.
May work in the clean room environment that requires gowning and no make up or jewelry.
May work in the clean room environment which can be a loud environment from 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.
Available to work over-time, weekends, and holidays as needed.
PLEASE NOTE: Our client has mandated COVID-19 vaccination for their workforce, all external personnel providing services to our client are required to comply with this requirement.