Proclinical is seeking a Metrologist for a leading pharmaceutical company located in Hunt Valley, MD.
The Metrologist will be a member of the Quality Control team supporting the pharmaceutical laboratories. This individual will maintain chromatography instrumentation in a validated state, perform assessment, troubleshooting, and repair.
Must be eligible to work in the US.
- Coordinate the maintenance and calibration of all laboratory equipment utilizing the calibration manager for scheduling.
- Calibration and qualification of laboratory equipment.
- Provide technical support to the laboratory, including knowledge of equipment, installation, and optimization of equipment, troubleshooting problems, and repair of instrumentation.
- Provide training to laboratory employees on the use of analytical equipment.
- Writing protocols, procedures, test methods, and memorandums.
- Revision of SOP's, specifically adding or revising the calibration and/or qualified procedures.
- Provide technical support during audits or audit responses.
- Assist other departments with technical problems.
- Contact Technical Support for instrument problems or for installation and operation questions.
- Utilize Kaye Lab Watch Monitoring System to monitor the temperature and humidity of the Stability Chambers.
- Assist laboratory with analytical or method development.
- Order parts or supplies related to the repair, maintenance, and calibration of laboratory equipment.
- Review and sign vendor-performed qualifications.
- Research major equipment purchases to ensure that the equipment met user requirements.
- Order analytical laboratory equipment.
- Perform other duties as assigned.
Skills and Requirements:
- Bachelor's degree in the sciences, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities.
- 5 years of experience as a chemist preferred.
- Demonstrate the ability to establish good working relationships with other departments, including vendors, colleagues, and subordinates.
- Demonstrates the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision.
- Demonstrate the ability to analyze data and information and assess and resolve complex problems/issues as required.
- Must be able to comprehend and follow all applicable SOPs.
- Demonstrate knowledge and experience with electronic Quality Management Systems such as MasterControl and Trackwise.
- Demonstrate solid understanding/ability to acquire the appropriate knowledge from resources on the current federal, local, and international regulations regarding the production, testing, and release of drug substances and products.
- Good understanding of cGMPs, industry, and regulatory standards and guidelines.
- Demonstrate familiarity with Microsoft programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc.
- Demonstrate the ability to portray the appropriate level of integrity and professionalism.
- Demonstrate the ability to communicate effectively with management, staff, regulators, and client representatives in written and verbal formats.
- Demonstrate the ability to complete tasks accurately and according to established and shifting timelines.
- Demonstrate the ability to make quality scheduling, resource allocation, and priorities decisions.
- Energetic, execution-focused, self-motivated, and organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
- Results-oriented and efficient.
- Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.
- Demonstrate the ability to work closely with a diverse customer and employee base (internally and externally).
- Demonstrate the ability to work well in a cross-functional team environment.
- Must communicate fluently in English and have legible handwriting.
- Ability to travel between and within facilities to visit staff, operations, and projects, as needed.
- Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary).
- Ability to lift up to 40 pounds on occasion.
- Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary).
If you are having difficulty in applying or if you have any questions, please contact Jessika Rodriguez at +(1) 617-391-0929 or email@example.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.