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Quality Control Specialist II - Equipment

Location: Cambridge, Massachusetts Salary: US$40 - US$70 per hour
Sector: Pharma & Biotech, Quality Assurance (QA) Type: Contract

Quality Control Specialist II - Equipment

Position Description:

This company is looking for a skilful Equipment Specialist to add to our QC team in the Greater Boston Area. Your roles will include collaborating with other teams in the company, as well as partner firms, investigating and troubleshooting issues. You will also administer the maintenance and operations of Quality Control equipment to support commercial operations and global product filings for liposomal cancer drugs. You will be expected to be able to work independently in the laboratory with very little oversight.

Job Responsibilities:

  • Analytical equipment management including the scheduling of both non-routine and routine maintenance.
  • Collaborate closely with vendors on management and service contracts setup, and on troubleshooting hardware and software related problems.
  • Responsible for management of the Empower Enterprise System, which includes working with the vendor on troubleshooting and administrative functions.
  • Both manage and write all equipment relevant to CAPA's and Change controls in Quality Control.
  • Collaborate closely with the Validation, IT and Quality Assurance for the setup of equipment and the associated software IQ/OQ and validation activities.
  • Collaborate closely with the Facilities/Engineering group for assets as well as work orders in the lab.
  • Both manage and write all equipment relevant to CAPA's and Change controls in Quality Control.

Requirements:

  • BA/BS degree in Biochemistry or a related field.
  • 5-7 years of experience with software management and Analytical Equipment.
  • Outstanding knowledge of the Empower Enterprise software.
  • Both motivated and reliable with a strong desire to work across different teams and departments, including Validation, QA and IT.
  • Proven experience in GMP quality systems for continuous improvements, such as Change Control and CAPA.
  • Must act as a leader in the QC laboratory, and be able to work independently with minimal oversight.
  • 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.
  • A good understanding of computerized systems such as LIMS is a preferred, but not required.
  • Proven knowledge of the current regulations, compendia, and guidance (e.g. ICH Q2, USP <1224> &<1225>, CFR 211, and EP 2.2.46

If you or a Quality Control Specialist you know feel this could be an opportunity you would like to explore please send your most up to date resume to myself at J.McAfee (at sign) Realstaffing.com to discuss this role.

Thank you!

Sthree US is acting as an Employment Business in relation to this vacancy.