The QC Scientist (GMP Services) will lead methodology transfer from Process and Product Design. This position is also responsible for researching and evaluating improvements to process and technology.
Essential Duties and Responsibilities:
- Research and assess process/technology improvements
- Lead or support transfer of methodology from R&D
- Devise or develop new analytical methods and/or techniques
- Support, lead or actively contribute to a team setting within the laboratory and potentially with other departmental work teams to: increase efficiency, solve problems, generate cost savings, improve quality, and provide new innovation support
- Actively contribute to the environmental monitoring program; microbial identification, organism risk assessments
- Perform testing and sampling to support manufacturing, validation, process development and stability studies in a GMP environment
- Gathers data and documents test results
- Create, revise and update standard operating procedures (SOP), qualification/validation protocols and reports
- Lead or assist in characterization/qualification/validation of methods
- Accurately generation quality documents to meet Good Documentation Practices (GDP) and Aldevron expectations
- 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
- Mentor and train other quality control staff regarding good laboratory practice and safety
- Lead analytical investigations
- Address and manage deviations related to analytical procedures
- Perform data entry and reviews own work for accuracy in accordance with laboratory procedures, standards and GMP requirements
- Perform testing and data analysis supporting DNA, RNA, protein and antibody sequencing projects
- Perform review of test data with application of GDP
- Perform advanced assays requiring precise analytical skills
- Responsible for assisting with the following list of tasks, not intended to be all-inclusive, to be completed and properly documented to ensure customer satisfaction.
- Independently run all established QC assays
- Preparation of QC buffers
- 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 3 years of experience working in a molecular biology, biochemistry or microbiology laboratory environment.
- Experience in assay optimization, experimental design, data analysis and data and concept presentation.
- Ph.D. in biochemistry or related scientific field, preferred. Minimal of Master's degree with 3 years of relevant work experience or Bachelor's Degree with 5 years of relevant work experience required.
Skills and Knowledge:
- Proven track record of creative scientific accomplishment as evidenced by publication and/or patent record
- Operate precision measuring tools and equipment
- Must be able to develop solutions for simple and complex problems, which require a high degree of ingenuity, creativity and innovation
- Ability to work on cross functional teams and apply influencing skills in a matrix environment
- Have good manual dexterity
- Demonstrate high ethical standards, trustworthiness with strong communication and leadership skills
- Ability to follow written procedures and written or verbal directions
Other characteristics such as personal characteristics:
- Have good depth perception and steady hands for pipetting
Who is Aldevron?
Aldevron is a leader in advancing biological science. Our custom development and manufacturing services provide scientists around the world with the essential components to accelerate research and open up their laboratories for groundbreaking science and breakthrough discoveries.
Why choose Aldevron?
We are in a landmark moment in the history of life science, and Aldevron is at the center of it. With our commitment to quality, we provide career opportunities that allow employees to grow and succeed, while helping make everybody's lives better.