We are looking for highly qualified candidates with at least 2 - 5 years of hands-on experience within a GMP QC lab to be part of a growing quality organization for a clinical-stage biotech company in Maryland.

Responsibilities

• Execute Raw Material, Drug Substance and Drug Product release testing in support of Phase I, II, III and commercial manufacturing of biotechnology products

• Execute Method Validation Protocols

• Interpret test results, compare them to established specifications and control limits, and make recommendations on appropriateness of data for release

• Train other analysts to perform laboratory procedures and assays

• Serve as a technical liaison between quality control and other departments, vendors, or contractors.

• Write or revise Standard Operating Procedures, Work Instructions, Standard Test Methods and Forms

• Participate in functional teams with various experience levels and provide input as needed on assay’s issues.

• Generate Deviation/Out of Specification reports, Change Control requests and CAPAs

• Complete documentation needed to support testing procedures including data capture forms, equipment logbooks, or inventory forms

• Monitor testing procedures to ensure that all tests are performed according to established item specifications, standard test methods, or protocols

• 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

REQUIREMENTS

• BS degree and 2 to 5+ years' experience supporting GMP QC Laboratories

• Experience in biologic’s intermediate, release and stability testing

• Strong computer skills with the Microsoft Office product line.

• Understanding of regulations governing documentation, data collection and data integrity

• Strong communication skills: oral/written and listening. Ability to effectively communicate (orally and written) with all levels of personnel

• Ability to work individually and in a team environment

• Ability to work under pressure and analyze processes within scheduled timeframes

• Experience in Technical Writing

• Hands on experience in one or more of the following assays: ELISA, SEC-HPLC, RP-HPLC, cIEF, SDS, A280, Endotoxin and Cell Culture Based Assays