Quality Control (Q/C) P-Chem Analyst II at CLENE NANOMEDICINE INC

North East, Maryland, United States -

Full Time

Start Date

Immediate

Expiry Date

11 Jun, 26

Salary

0.0

Posted On

13 Mar, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

SOPs, TSMs, GMP, GLP, CEM Discover SPD Microwave Digester, Agilent ICP-MS 7700x/7900, Malvern Zetasizer ZS90, ThermoFisher UV-Vis, pH/Conductivity Meter, Shimadzu TOC-Vwp, Analytical Characterization, Instrument Calibration, Equipment Validation, Troubleshooting, MS Office

Industry

Pharmaceutical Manufacturing

Description

Description The Quality Control (Q/C) P-Chem Analyst II position will assist in the analysis of bioanalytical specimens obtained from animal and clinical studies conducted at contract research organizations. In addition, this position performs the analysis of production samples received from the manufacturing plant or research and development laboratory. Excellent benefits package, including, but not limited to: - Up to 4 weeks paid leave. - Paid holidays. - Eligible for medical, dental, vision, and prescription coverage (employee & family). - 401(k) retirement plan with employer match. Requirements Essential Duties and Responsibilities This position is required to follow all Standard Operating Procedures (SOPs), Test Methods (TSMs), Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and internal processes. Duties will include, but not limited to: - Assist in the analysis of bioanalytical specimens (e.g., blood, urine, tissues). - Support development of validation protocols and reports. - Create and edit test methods and other quality documents. - Perform analytical characterization using all lab equipment, including, but not limited to: - oCEM Discover SPD Microwave Digester - Agilent ICP-MS 7700x/7900 - Malvern Zetasizer ZS90 - ThermoFisher UV-Vis - pH/Conductivity Meter - Shimadzu TOC-Vwp - Follow cGMP and cGLP standards, SOPs, and TSMs. - Execute and lead lab equipment validation and qualifications, when necessary. - Calibrate analytical instrumentation. - Maintain supply inventory and MSDS, including requesting purchase orders. - Attend as required, and successfully complete training on analytical instrumentation and procedures. - Report any issues that may affect the identity, strength, quality, and purity of the product. - Report any improvements to lab performance. - Assist in research and development experiments and all activities related to development. - Perform lab equipment verification. - Lead research and development experiments. - Troubleshoot lab equipment. - Assist in the shipping of samples for outsource testing. - Perform other duties as assigned. Education and/or Experience This position requires the following: - Bachelor's Degree in a related science field. - One (1) to two (2) years' experience in a laboratory environment. - Proficient computer skills, including, but not limited to, MS Office. - Excellent verbal and written communication skills with all levels. Physical Demands The physical demands described are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. - Ability to lift up to 20 pounds. - Ability to read and interpret documents such as, operating, maintenance, and procedure manuals. Work is normally performed Monday through Friday during normal business hours. Resume must accompany online application to be considered to this position

Responsibilities

This role involves assisting in the analysis of bioanalytical specimens from animal and clinical studies, as well as analyzing production samples from manufacturing or R&D labs. Duties include executing analytical characterization using specialized lab equipment and maintaining quality documentation.