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