Quality Control (Q/C) P-Chem Analyst I 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

Bioanalytical Specimen Analysis, Analytical Characterization, Laboratory Equipment Operation, cGMP Compliance, cGLP Compliance, SOP Adherence, Test Method Creation, Instrument Calibration, Equipment Validation, Inventory Maintenance, MSDS Management, Troubleshooting, Research and Development Support, Verbal Communication, Written Communication, MS Office Proficiency

Industry

Pharmaceutical Manufacturing

Description

Description The Q/C P-Chem Analyst I assists in the analysis of bioanalytical specimens obtained from animal and clinical studies conducted at contract research organizations. In addition, this position supports and 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). - Perform proficiently analytical characterization using all lab equipment. - Follow cGMP and cGLP standards, SOPs, and TSMs. - Create and edit test methods and other quality documents. - Calibrate analytical instrumentation and lab equipment, including validation and qualification. - Maintain supply inventory and MSDS, including requesting purchase orders. - Attend and successfully complete all required training. - 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. - Troubleshoot lab equipment. - Perform other duties as assigned. Education and/or Experience This position requires the following: - Bachelor's Degree in a related science field, preferred. - One (1) to two (2) years' experience in a laboratory environment, required. - 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

The Quality Control P-Chem Analyst I assists in analyzing bioanalytical specimens from animal and clinical studies, and performs analysis on production samples from manufacturing or R&D labs. Duties include performing analytical characterization, calibrating instrumentation, and creating/editing quality documents while strictly following SOPs, GMP, and GLP standards.