Quality Control Analyst
The QC Analyst will support the establishment and growth of BioFactura’s QC department. Responsibilities will include, but not limited to, performing QC testing of Drug Substance/Drug Product release and stability samples in support of BioFactura programs ensuring compliance with established standards; cross-training with Analytical Development (AD) to enable assay transfer to QC and assay validation activities; and authoring and reviewing
of method SOPs, protocols and reports.
• Execute Drug Substance and Drug Product release and stability testing in support of Phase I, II, III and commercial manufacturing of biotechnology products.
• Draft and execute Method Qualification/ Validation Protocols.
• Complete documentation needed to support testing procedures including data capture forms, equipment logbooks, or inventory forms.
• Interpret test results, compare them to established specifications and control limits, and make recommendations on appropriateness of data for release.
• Write or revise Standard Operating Procedures, Work Instructions, Standard Test Methods and Forms.
• Generate Method Validation and Deviation/Out of Specification reports, Change Control requests and CAPAs.
• Monitor testing procedures to ensure that all tests are performed according to established item specifications, standard test methods, or protocols.
• Train other analysts to perform laboratory procedures and assays.
• Serve as a technical liaison between quality control and other departments, vendors, or contractors.
• Participate in functional teams with various experience levels and provide input as needed on assay issues.
• Supply quality control data necessary for regulatory submissions.
• Evaluate new technologies and methods to make recommendations regarding their use.
• Ensure that lab cleanliness and safety standards are maintained.
• Identify and troubleshoot equipment problems.
• Evaluate analytical methods and procedures to determine how they might be improved.
• Support QC laboratory inspection readiness strategy and activities.
Education & Experience:
• Bachelor’s degree and hands on-experience in Compendial assays testing (pH, A280, Sub-Visible Particles, Appearance), Endotoxin (Kinetic Chromogenic) and ELISAs.
• Experience with large molecules.
• Hands on experience in housekeeping of GMP QC Laboratories.
Required Knowledge, Skills & Abilities:
• Excellent verbal and written communication skills, including technical writing.
• Excellent organizational skills and attention to detail.
• Proficiency with Microsoft Office Suite.
• Strong level of initiative and quest for knowledge and growth.
• Ability to prioritize and manage tasks and operational flexibility.
• Ability to work well in a team and as an individual contributor.
• Ability to function well in a high-paced and at times stressful environment.
• Prolonged periods of sitting at a desk, working on a computer and scientific lab bench.
• Must be able to lift up to 20 pounds at times.
BioFactura develops and commercializes biodefense drugs, novel drugs, and high-value biosimilars (i.e., follow-on biologics or generic biopharmaceuticals) using its patented StableFast™ Biomanufacturing Platform, the optimal choice for bringing these products to market with faster, lower cost, superior-quality manufacture. For over 10 years, BioFactura has been advancing life-saving medicines from the research bench to the patient using its innovative drug development and manufacturing technologies. Current and past programs include biodefense drugs against smallpox and Ebola, novel medicines for cancer, and low-cost/high-quality biosimilars for autoimmune and infectious diseases.