uniQure

QA Laboratory Operations Lead - Lexington

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Job

Active since 10-05-2018 Job category Quality / Health / Environment ...
Location Lexington Level Professional
Educational level Bachelor / Graduate Employment type -
Hours 40 Salary Competitive
Place in the Organization:

uniQure is dedicated to bringing therapies for 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 life (i) by living up to high quality standards and (ii) by recognizing the sense of urgency in areas of high medical need.

The QA Laboratory Operations Lead position provides a variety of customer services to the Quality Control (QC) departments with supportive services to the Facilities Management (FM) and Manufacturing (MFG) groups including QA review of controlled documents related to product/utilities testing, and data review.

Key result areas (major duties, accountabilities and responsibilities):

  • Review and approve protocols, data and reports relating to method validation and compendial testing.
  • Review and approve analytical method transfer protocols, data, reports, and supportive study materials.
  • Review and approve data and records associated with raw material, in-process, drug substance (DS), drug product (DP), clinical and commercial packaged product.
  • Represent Quality Assurance to guide various special projects and technical meetings, such as with the Method Technical Transfer project, as needed.
  • Review and approve Out of Specifications, Environmental Monitoring Excursions and other laboratory investigations including subsequent Quality Investigations and Corrective and Preventive Actions (CAPAs).
  • Provide metrics reporting and status updates to QA Management relating to laboratory QS activities.
  • Create, review, and approve documents including Standard Operating Procedures, Quality Metrics Reports, Annual Product Reviews, and other documents, as needed.
  • Provide daily QA support for general laboratory activities.
  • Assist with internal and external audits as necessary (e.g. of CTLs)
  • Perform other quality/compliance related tasks as required.

Qualifications:

Education:

  • BA/BS in Biology/Microbiology, Chemistry, Chemical Engineering or related technical field.
  • Ph D or MS in Biology/Microbiology, Chemistry, Chemical Engineering or related technical field desired.

Experience:

  • 5-9 years of relevant GMP experience in pharma/biotech Company, working within a quality system and regulated GMP environment. Advanced technical degree in related field accepted in lieu of years of experience.
  • Knowledge and experience in laboratory analyses, method development and laboratory controls.
  • Working knowledge of FDA regulations required. EU regulations preferred.

Core competencies:

  • Must have a working knowledge of cGMP/ICH/FDA regulations and guidelines. EU regulations is a PLUS.
  • Excellent organizational skills with a “do-what-it-takes” attitude with ability to multi-task in a fast-paced environment with changing priorities.
  • Self-motivated, self-starter, detail oriented and good problem-solving skills REQUIRED.
  • Ability to work effectively in a team setting is a MUST.
  • Excellent verbal /writing skills and ability to influence across multiple functions where results are achieved through influence and the incorporation of multiple points of view.
  • Must be able to work collaboratively with cross-functional groups to ensure compliance and adherence to regulations and established procedures.
More information
This listing is a full-time job

Job category Quality / Health / Environment / Safety
Industry / Industries Biotechnology
Region United States
Keywords Quality Assurance, GMP

Contact information

Name Jennifer Wagner

Location

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