uniQure

QC Analytical Lead Analyst - Lexington, MA

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Job

Active since 23-05-2017 Job category Pharmacy
Location Lexington, MA Level Professional
Educational level Bachelor / Graduate Employment type -
Hours 40 Salary Competitive
uniQure is dedicated to bringing innovative therapies or unmet medical needs to patients. In doing so each function in uniQure is directly or indirectly responsible for the lives of patients. This responsibility should be part of our day-to-day working lives by (i) living up to high quality standards and (ii) by recognizing the sense of urgency in areas of high medical need.

Main purpose of the job:

The QC Lead Analyst will be responsible for routine/non-routine QC testing according to Standard Operating Procedures (SOPs). This position will be based at uniQure’s new state of the art facility in Lexington, MA.


Key Responsibilities:

  • Able to work independently with minimum supervision.
  • Proficient with regulatory guidance’s and regulations.
  • Lead with the new projects.
  • Lead method transfer /set up from Amsterdam and method validation.
  • Develop protocols for equipment validation, method validation, and special projects.
  • Lead troubleshooting and complex investigation (equipment and analytical testing methods)
  • Establish, revise, review and maintain procedures (including protocol and technical report).
  • Responsible for change control, OOSs deviation related to QC operations
  • Assist with audits and regulatory inspections, as required.
  • Oversee sampling and storage of QC samples and maintain retain inventory.
  • Maintenance of laboratory equipment/instrument and systems to ensure compliance.
  • Perform routine/non-routine testing of in-process, final product, raw material samples in accordance with Standard Operating Procedures such as Protein Assays (Bradford, Lowry), Q-PCR, Potency Assay, Western Blot, HPLC, Refractometry, Osmolality, ELISA, etc.
  • Aseptic technique and working with Cell Maintaince, Cell Passaging, Cell Counting, Cell culture and live viruses.
  • Responsible for protocol and report generation, as required.
  • Perform sample management such as receipt, inventory, tracking
  • Coordinate shipment of samples to contract testing laboratories, as required.
  • Trend data and aid in compilation of trend reports.
  • Complete documentation in accordance with current Good Manufacturing Practices (cGMP).
  • Maintain QC lab and related systems to ensure compliance with industry standards.
  • Responsible for change controls, OOS and deviations related to QC raw materials, including investigations, as required.
  • Work in compliance with cGMP’s, effectively demonstrates an understanding of cGMP's and how it applies to specific responsibilities
  • Communicates inter-departmentally and with outside contacts to solve technical issues
  • Exercises sound judgment and decision making when problem solving
  • Other duties, as assigned

Other Responsibilities:

  • Represent QC Group on cross-functional team
  • Performs data review
  • Manage technical studies performed with external companies with provision and review of reports.
  • Maintain QC Laboratory related systems in compliance with industry standards.
  • Training of other QC Analysts within the department.
  • Other tasks, as assigned

Qualifications and Skill Requirements:

  • BA or BS in Chemistry/Biochemistry or other related science science related
  • Minimum 8 years of analytical laboratory base experience within QC testing capacity, preferably in GLP/cGMP environment.
  • Excellent technical experience and functional knowledge of related equipment with cGMP.
  • Computer literacy (MS Word, Excel ), good communication and organizational skills are required.
  • Ability to work and prioritize under pressure in an international environment.

 

More information
This listing is a full-time job

Job category Pharmacy
Industry / Industries Pharmaceutical
Region United States
Keywords Quality Control, Analyst

Contact information

Name Jennifer Wagner

Location

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