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Randstad GxP Quality Support Lead in boston, Massachusetts

GxP Quality Support Lead

job details:

  • location:Boston, MA (remote)

  • salary:$59.93 - $68.95 per hour

  • date posted:Wednesday, April 7, 2021

  • job type:Contract

  • industry:Manufacturing

  • reference:832378

job description

GxP Quality Support Lead

job summary:

Come join our team where we are innovators, leaders, and collaborators. And at the heart of everything we do is an intense desire to pursue the toughest challenges and truly change the world for people living with rare and devastating diseases.We are incredibly proud that our work has been recognized globally through some of the industry's highest honor.

location: Boston, Massachusetts

job type: Contract

salary: $59.93 - 68.95 per hour

work hours: 8am to 5pm

education: Bachelors

responsibilities:

Position Summary

This position will be a member of the GxP Rapid Response team initiatives for Central Quality System and Compliance. The Quality Support Lead will also serve as a cross-functional member for key initiatives in Central Quality Systems and Compliance.

The Quality Support Lead is responsible for maintaining and improving Quality System processes to ensure. Quality initiatives are completed and delivered on time. Quality Support Lead requires excellent communication skills and someone self-motivated and a self-starter to drive for implementation and Quality issues. The Quality Support Lead must possess strong verbal and written communication skills and sound organization skills applicable to planning, reporting, and archiving/knowledge transfers

Job Duties & Responsibilities

Work with Subject Matter Experts supporting process compliance/ improvements to Quality Management System Elements such as CAPAs, Deviation, Change Control, Supplier Quality Management, Audit, Inspection, and Notification to Management Be an individual contributor supporting the implementation of Quality process initiatives Serve as active partner across Alexion GxP groups, providing support and consultation to our Quality Business Partners and Business customers Perform other related duties and special projects as required or requested. Support Quality programs in accordance with Health Authority regulations.

Essential Qualifications

  • 4 to 8 years of experience in biopharmaceutical/pharmaceutical or related industry with strong background

  • Hands-on experience in working in agile or fast paced teams

  • Experience participating in cross-functional projects

  • Proficiency with Microsoft Office Suite (Outlook, Excel, Word, Smarts sheets and box etc.)

  • strong interpersonal communication skills

  • Demonstrated passion and skills for problem solving

  • High attentiveness to detail

  • Proven ability to quickly learn new information and communicate requirements to the appropriate individuals.

Preferred Qualifications

Advanced quality certification strongly desired (i.e., Six Sigma Green Belt, Certified Lean Expert, etc.)

Education

Bachelor's degree in chemistry, life sciences, or related field with strong background

qualifications:

  • Experience level: Experienced

  • Minimum 5 years of experience

  • Education: Bachelors (required)

skills:

  • audit

  • archiving

  • biopharma

  • Pharmaceutical

  • GxP

  • Six Sigma

  • Microsoft

  • Excel

  • Quality System

  • Outlook

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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