The Quality Control Analyst II supports the manufacturing, validation and process development and stability functions of Aldevron by analyzing GMP projects by through testing, sampling, and completing the applicable documentation.
Essential Duties and Responsibilities:
- Act as primary analyst for GMP projects and completion of appropriate documentation
- Perform testing and sampling to support manufacturing, validation, process development and stability studies in a GMP environment
- Gathers data and documents test results
- Assist in qualification/validation of methods as needed
- Perform routine equipment maintenance and assist in troubleshooting as needed
- Accurately document and compare testing results against control/specification limits
- Initiate nonconformance reports for failing materials, Out-of-Spec investigations, Lab Investigations, Root Cause and CAPA related activities
- Create, revise and update standard operating procedures (SOP) as requested
- Mentor and train other quality control staff
- Perform routine and non-routine laboratory testing
- Data entry into manufacturing summary reports
- Perform data entry and peer review of quality documents for accuracy in accordance with laboratory procedures, standards and GMP requirements
- Perform advanced assays requiring precise analytical skills
- Perform testing and data analysis supporting DNA, RNA, protein and antibody sequencing projects
- Independently run all established QC assays
- Preparation of buffers along with pH adjustment
- Handling of product, including transfer of material for shipments of in-process samples and outsourced testing
- Maintain inventory of standards, reagents, and other lab consumables
- All employees are responsible for the general upkeep of work and shared spaces
- Other duties as assigned
- Minimum 1-year experience working in a laboratory environment
- Bachelor's degree in Science related field preferred
Skills and Knowledge:
- Operate precision measuring tools and equipment
- Perform inspection of vials
- Ability to follow written procedures and written or verbal directions
- Ability to manage time performing several different tasks throughout the day
- Work as a team member
- Have good depth perception and steady hands for pipetting
- Have good manual dexterity
This position works in a lab setting and may come in contact with various solutions and chemicals, and will be responsible for activities related to biological processes such as bacterial growth.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; bend; lift up to 50 pounds; use hands to finger, handle or feel; and reach with hands and arms.
Aldevron is a custom manufacturing organization that provides plasmid, protein and antibody development and production services. Headquartered in Fargo, ND with locations in Madison, WI and Freiburg, Germany we constantly look to innovate and advance life science through collaborative partnerships. Aldevron works with leaders in pharmaceutical, biotech and research institutions around the world to accelerate the development of drug, treatment and preventions for numerous diseases and genetic disorders. Our reputation for innovative solutions for our clients has allowed us to expand our organization and offerings in all service platforms. We are working in a landmark moment in the history of life science.