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Quality Assurance Specialist

Company: WAVE Life Sciences
Location: Lexington
Posted on: January 16, 2022

Job Description:

Wave Life Sciences (Wave) is a biotechnology company focused on delivering transformational therapies for patients with serious, genetically defined diseases. We differentiate ourselves through our proprietary chemistry platform that enables the production of stereopure oligonucleotides precisely targeting the underlying cause of rare diseases. At Wave, we welcome those who share a passion to change lives and embrace a culture that is thoughtful, dynamic, humble, and fearless. Together, we can contribute to our mission enabling every patient with a genetic disease to have access to life changing treatments.
Wave is seeking a Quality Assurance Specialist to join the Quality organization. This individual will be responsible for providing Quality Assurance (QA) support to and review of documentation from Manufacturing, Quality Control, Process Development, Supply Chain and other teams for clinical manufacturing and testing. This individual is expected to work onsite in Wave's Lexington, MA location at least three days per week.
Position Responsibilities:
The Quality Assurance Specialist responsibilities may include some or all of the following:

  • Review of data including but not limited to stability data, protocols, and summary reports and trending.
  • Review batch records, testing records, certificates of analysis, logs, and other documentation to ensure compliance and adequate documentation, in support of drug substance and drug product disposition
  • Review stability protocols and reports
  • Write, review and approve GMP documentation (SOPs, protocols, technical reports, specifications, etc.)
  • Review and approve work orders for GMP facilities and equipment
  • Perform activities for raw materials including but not limited to review and disposition of materials, creating/updating specifications
  • Assist in the implementation of GXP quality standards, policies, and procedures.
  • Perform activities related to quality events such as out of specification investigations, change controls, deviations, and CAPAs
  • Support equipment validation, maintenance and calibration activities including document generation, review, and approval
  • Collaborate with Manufacturing to resolve equipment and process issues
  • Participate in internal audits and ensure that related follow-up activities are performed
  • Coach/train QA and other functional teams
  • Cross train on other QA functions
  • Other related activities as necessary

    Education / Experience:

    • Bachelor's degree in biology, chemistry or a similar scientific field
    • Minimum of 3 - 5 years of work experience in a Quality Assurance / Materials organization
    • Must have experience working in a GMP environment in the pharmaceutical or biotechnology industry
    • Detail focused with excellent organization and communication skills

      Throughout the global pandemic, Wave has been committed to ensuring the safety of all employees and their families, while continuing to move the business forward so that we can deliver on our commitment to patients. We have implemented an approach to COVID-19 that is informed by the science and aligns to recommendations established by the CDC and other applicable government health agencies. To that end, Wave has implemented a mandatory COVID-19 vaccination policy that requires its employees to be vaccinated to the maximum extent permitted by applicable law.
      Wave Life Sciences provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Wave Life Sciences complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
      Wave Life Sciences expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. Improper interference with the ability of Wave Life Sciences employees to perform their job duties may result in discipline up to and including discharge.

Keywords: WAVE Life Sciences, Boston , Quality Assurance Specialist, Other , Lexington, Massachusetts

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