Chemist - I at American Cybersystems, Inc. in Elkton, Virginia

Job Description:

Job Description: • Performs analytical testing in the Quality Control laboratory on a variety of samples including drug substances, drug products, and/or incoming materials. • Prevalent techniques include HPLC, UPLC, GC, ICP, sub-visible particles, IR, UV/VIS, titrations, and others. • Ensures test data is accurate and all work is Right-First Time. • Works closely with laboratory team members to ensure the highest levels of GMP compliance and inspection readiness. • Routinely participates in laboratory related activities such as second person review validation, qualification, report writing, deviation investigations, training, and others. • Must be able to work independently in an open team environment and have strong problem solving and communication skills. • This position will be responsible for assisting with laboratory GMP activities by performing instrument calibrations, instrument troubleshooting, laboratory atypical result investigations, inspection preparations (external agency, internal GMP, housekeeping}, manufacturing guideline compliance support, and sample flow management. • Capable of interacting with and understanding various data acquisition/management software and Laboratory Information Management Systems.

Responsibilities: • Performs analytical testing in the Quality Control laboratory on a variety of samples including drug substances, drug products, and/or incoming materials. • Prevalent techniques include HPLC, UPLC, GC, ICP, sub-visible particles, IR, UV/VIS, titrations, and others. • Ensures test data is accurate and all work is Right-First Time. • Works closely with laboratory team members to ensure the highest levels of GMP compliance and inspection readiness. • Routinely participates in laboratory related activities such as second person review validation, qualification, report writing, deviation investigations, training, and others. • Must be able to work independently in an open team environment and have strong problem solving and communication skills. • This position will be responsible for assisting with laboratory GMP activities by performing instrument calibrations, instrument troubleshooting, laboratory atypical result investigations, inspection preparations (external agency, internal GMP, housekeeping}, manufacturing guideline compliance support, and sample flow management. • Capable of interacting with and understanding various data acquisition/management software and Laboratory Information Management Systems.

Qualifications: • BS/BA in Chemistry, Biology, Biochemistry, or other relevant disciplines. • 0-2 years experience. Required Experience and Skills: • Applicant must be able to work independently in an open and diverse team environment. • Time management and strong communication skills. • Strong problem solving and laboratory-related software application skills. • Physical: ability to lift up to 20lbs Preferred Experience and Skills: • New graduates are welcome to apply. • Quality Control, Quality Assurance and/or cGMP experience. . • Experience with Micro-pipetting techniques. • Experience with HPLCs, UPLCs or GCs Note: • Off-shift work: 12hrs shift. 6am-6pm EST. • Flexible to work during weekends • Rotating shift schedule: example: First week-44 hrs (Tuesday, Wednesday, Saturday and Sunday), 2nd week-36 hrs (Monday, Thursday,Friday) and so on. • IMPORTANT: ** Expected to work in an environment with potential beta-lactam antibiotic exposure ** so do not submit anyone who is allergic. Beta lactam screenings will be required post-offer.