Perform technical executions of qualification protocols on new or upgraded laboratory instruments (HPLC, GC, UV-Vis, FTIR, Karl Fischer, etc.) and equipment software to ensure compliance with applicable SOP's and cGMP regulations. This involves preparation of any testing materials, e.g. standards, necessary to execute the testing protocols. This position will work with Data Integrity and Quality Control Lab personnel to identify shortfalls in test protocol language, or equipment/ software functionality and advise and develop corrective measures to complete assigned qualification protocol execution.
- Provide technical input, review and assessment on the development of laboratory equipment software qualification protocols.
- Perform execution of laboratory equipment software qualification protocols, while providing objective evidence and adhering to good documentation practices.
- Assist in the investigation and associated root cause analysis of any protocol deviations.
- Develop corrective measures for any anomalies or deviations associated with qualification protocols
- Assist in maintaining QC records such as equipment/instrument drawings and specifications, protocol and validation records and reports, etc., as required to establish and maintain control of all processes, systems and equipment.
- Quality control
- Laboratory experience
Additional Skills & Qualifications:
- Bachelor Degree in Chemistry or related field required.
- Minimum 3 years of experience in a regulated laboratory setting working with equipment.
- Proficient in the use of several of the following laboratory instruments: HPLC, Analytical Balance, pH meter, automatic pipettes, FTIR, UV-Vis, Voltammeter, Autotitrator, ICP, Flame AA, TOC, Conductivity meter.
- Working knowledge of GMP regulations, Data Integrity requirements, and Good Documentation practices as they relate to a QC laboratory.
- Working knowledge of regulatory and compendial guidelines concerning the establishment, documentation of test procedures, and equipment qualification and validation.
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.