
Beyond a Resume
Beyond A Resume seeks a Quality Control Analyst for our Biotech client in Frederick, MD.
Job Summary:
The QC Analyst will support the establishment and growth of the QC department. Responsibilities will include, but not limited to, performing QC testing of DS/DP release and stability samples in support of 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.
Job Responsibilities:
-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.
-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.
Job Requirements, 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.
Physical Requirements:
-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.
Salary:
-Based on experience
To apply for this job email your details to tameka.spencer@beyondresumes.net