BS Life Sciences QC Job at Miltenyi Biotec | Apply Now
Join Miltenyi Biotec as a Quality Control Analyst II and play a vital role in advancing biomedical research. This position is essential for ensuring the quality and safety of vector products, directly contributing to groundbreaking work in cell and gene therapy. If you’re a skilled professional with a background in GMP environments and a passion for precision, this is your opportunity to make a real impact on a global scale.
- Job Position: QC Analyst II
- Location: Gaithersburg, MD 20878, USA
- Job ID: QCANA003409
- Job Category: Manufacturing
About the Company
Miltenyi Biotec is a family that is passionate about making a real impact—one breakthrough at a time. An integral division of that family is Miltenyi Bioindustry, a contract development and manufacturing organization (CDMO). As a full-scale CDMO, we provide customers with services for the development and manufacturing of lentiviral vectors and cell and gene therapy products. This crucial arm of our enterprise bridges the gap between research and mass bioproduction, ensuring that our solutions are accessible on a global scale.
Job Description
This position is primarily responsible for coordinating and conducting day-to-day Quality Control activities in the Replication-Competent Lentivirus (RCL) laboratory, which tests Vector Products at the end of the manufacturing process for RCL as required by FDA regulations. Activities may include, but are not limited to, GMP release testing and execution of Quality Control Method Development with minimal to no supervision. This role may also be responsible for performing all GMP activities to support client and internal company projects while following applicable SOPs with precision and accuracy and demonstrating a high level of documentation accuracy and clarity.
BS Life Sciences QC Job – Key Responsibilities
- Work on diverse client projects with different test methods and analysis of data.
- Communicate and collaborate effectively with colleagues, management, and other departments.
- Facilitate, coordinate, and conduct tasks (i.e., setting schedules to ensure timely completion of laboratory maintenance activities and assigned testing).
- Conduct and support the execution of routine and non-routine Quality Control Analyst GMP testing (i.e., molecular biology, immunology, and tissue culture assays). Responsible for the accuracy and validity of testing results.
- Support assay optimization, qualification, and validation for Quality Control Analyst.
- Maintain accurate and complete records in accordance with cGMP. Strictly follow test procedures and SOPs. Supports training in areas where qualified.
- May assist with equipment qualification and validation activities.
- Maintain an inventory of QC materials and lab supplies, including monitoring and ordering as needed.
- Participate in continuous improvement projects as needed and perform other duties as assigned.
- May support other functional areas or duties as necessary or assigned.
BS Life Sciences QC Job – Educational Qualifications
Bachelor’s Degree in the life sciences or related from a four-year college or university; 2-4 years of relevant experience and/or training in a laboratory or a cGMP/cGTP environment (clinical, microbiology, Cell Culture, immunology, or Quality Control); or an equivalent combination of education and experience. Must have hands-on experience working as a biopharmaceutical Quality Control Analyst.
BS Life Sciences QC Job – Experience and Skills
- Working knowledge of cGMP quality control analyst systems, including but not limited to change controls, deviations, CAPAs, GxP regulations, and standards.
- Experience in fulfilling material needs and supplies for a laboratory and effectively communicating cross-functionally.
Keywords: QC Analyst II, Quality Control Analyst, Miltenyi Biotec, Manufacturing Jobs, Biotech Jobs, GMP, cGMP, Laboratory Jobs, Molecular Biology, Immunology, Cell Culture, Gaithersburg, MD Jobs
