I am looking for an experienced Equipment Specialist to contribute a top QC team in the Greater Boston Area. Your roles will include troubleshooting, investigating, as well as collaborating with other teams within the company and partner firms. You will also manage the maintenance and operations of Quality Control equipment to support commercial operations. You will be expected to be able to work independently in the laboratory with very little oversight.
- Collaborate closely with the Facilities/Engineering group for assets as well as work orders in the lab.
- Responsible for management of the Empower Enterprise System, which includes working with the vendor on troubleshooting and administrative functions.
- Analytical equipment management including the scheduling of both non-routine and routine maintenance.
- Collaborate closely with the Validation, IT and Quality Assurance for the setup of equipment and the associated software IQ/OQ and validation activities.
- Both manage and write all equipment relevant to CAPA's and Change controls in Quality Control.
- Collaborate closely with vendors on management and service contracts setup, and on troubleshooting hardware and software related problems.
- 3-5 years of experience with software management and Analytical Equipment.
- BA/BS degree in Biochemistry or a related field.
- Both motivated and reliable with a strong desire to work across different teams and departments, including Validation, QA and IT.
- A good understanding of computerized systems such as LIMS is a preferred, but not required.
- Will need to both understand and apply good working knowledge of quality and GMP principles
- Must have the ability to handle multiple tasks concurrently and in a timely fashion.
- Must act as a leader in the QC laboratory, and be able to work independently with minimal oversight.
- Proven experience in GMP quality systems for continuous improvements, such as Change Control and CAPA.
- Strong Technical Knowledge of Analytical Equipment such as Fluorescence, HPLC's with ELSD, TOC analyser, Malvern Particle size, UV, UV/Vis spectrophotometers, and other standard wet chemistry equipment.
- Proven knowledge of the current regulations, compendia, and guidance (e.g. ICH Q2, USP <1224> &<1225>, CFR 211, and EP 2.2.46
Sthree US is acting as an Employment Business in relation to this vacancy.