Quality Control Manager
AltPep Corporation is a biomedical start-up with a breakthrough approach for diagnosing and treating some of the world’s most intractable conditions: amyloid diseases. Our lead programs are focused on Alzheimer’s Disease and Parkinson’s Disease.
We are seeking a highly motivated and experienced Quality Control (QC) Manager. This key position is responsible for establishing and implementing QC procedures and metrics for the company’s diagnostics and therapeutic programs, which are currently in early-stage development. Partnering with Quality Assurance (QA), the QC Manager ensures operational excellence is maintained across the company’s products and processes.
- Implement and maintain QC systems to ensure an ongoing supply of qualified materials for use in AltPep’s labs.
- Review data for compliance to specifications; initiate, investigate, and/or review nonconformities as required.
- Analyze and interpret QC test results, identify deviations, and make appropriate recommendations, as required.
- Work with R&D, QA and/or contract manufacturers (as appropriate) on the development of QC methods for new products. Participate in test method validation activities including protocol writing and execution, analysis and report generation.
- In coordination with R&D and QA, troubleshoot QC issues or concerns; perform root cause analysis and recommend solutions for future improvements.
- Track and report appropriate quality metrics.
- Minimum of 5 years of experience in the pharmaceutical/biotech and/or clinical laboratory industry. Experience in QA/QC and Med Tech or other lab-based experience required.
- Specific knowledge and experience in several of the following areas:
- Mass spectrometry
- Spectroscopy (variety)
- Peptide/protein purification
- ELISAs, Western Blots/dot blots, protein binding kinetics/analysis
- Tissue culture
- Strong quantitative analysis skills and experience using Excel, MATLAB, Tableau, or similar software.
- Strong working knowledge of CLIA, cGMP, GLP, and FDA guidance and regulations related to diagnostics and/or therapeutics.
- Experience to establishing QC protocols and SOP development
- Excellent computer, documentation, communication, and organizational skills required.
- Competency with electronic quality management systems.
- Must have strong attention to detail and an ability to work in a team environment.
- Demonstrated ability to exercise sound judgment and independent thinking.
- Bachelor's degree in, medical technology, chemistry, biochemistry, pharmaceutical chemistry, bioengineering, or related field, required.
- Master’s degree preferred.
- Starting from $110,000 per year.
AltPep offers a competitive compensation package, including equity incentives, as well as a benefits program designed to support the well-being of our employees and their families. Benefits include medical, vision and dental coverage, and group life insurance. To learn more about us please visit www.altpep.com. AltPep is an equal opportunity employer with the desire for diversity of all types. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, disability, or any other status protected by federal, state, or local law.
Full-time position; Must be authorized to work in the US.