Job Details
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.