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Quality Assurance Associate

Invenra, Inc. Madison, WI

  • Expired: over a month ago. Applications are no longer accepted.
Job Description

About Invenra:

We are a rapidly expanding and well-funded biotechnology company focused on employing cutting edge protein engineering and multi-specific antibodies to discover therapeutic solutions to challenging diseases. At Invenra, we start with biology, then employ our extensive technology toolbox and efficient discovery engine to design and create first- and best-in-class drug candidates. Using our proprietary B-BODY™, SNIPER™ and CLUSTR™ technologies, we have generated a robust pipeline of next-generation multi-specific antibodies to address unmet therapeutic needs in immuno-oncology and autoimmunity. Invenra’s employee-focused management and flexible work environment creates a culture of energy and innovation where everyone makes a difference, and everyone benefits from success. For more information, please visit www.invenra.com.

Position Summary:

Invenra is seeking a highly motivated Quality Assurance Associate to join our quality team. The Quality Assurance Associate will support document management, change control, training, coordinate periodic reviews of SOPs, and implementation of electronic Quality Management System (eQMS). The Quality Assurance Associate will work with all members of the company to ensure that document control requirements are met for the company and its customers.

Key Responsibilities:

  • Assist in deployment of an eQMS system.
  • Perform review of documents submitted through the change control process and provide editorial support to ensure the quality to all document content for format, completeness, and consistency adhere to company procedures and guidelines.
  • Collaborate with cross-functional departments to ensure timely implementation of document change controls and requests.
  • Track the status of documents being drafted or undergoing revision within the sites.
  • Manage electronic employee training assignments, job code assignments, and assist in the development of electronic training courses.
  • Initiate and manage document reviews and revision to achieve clear, concise, and accurate instructional documents.
  • Oversee and administer document lifecycle management.
  • Perform inspection and release of documents and materials for shipment to external customers (e.g., Product Data Sheets and labels, notebook entries for the material being shipped).
  • Review of equipment calibration reports.
  • Review of supplier change notifications, and communication internally regarding the changes.

Required Education, Experience, and Competencies:

  • Associate OR Bachelor’s degree with 1-2 years of experience is required.
  • Ability to follow directions for the successful completion of tasks.
  • Must be reliable and have a positive and professional attitude.
  • Enjoy and embrace handling multiple competing priorities in a fast-paced, changing team environment.
  • Strong organizational skills and ability to problem solve.
  • Effective time management skills and ability to multi-task.
  • Must have strong written and verbal communication skills.
  • Ability to work well independently and as part of a team.
  • Demonstrated ability to think proactively, and collaboratively propose/implement solutions.

Preferred, but not required:

  • Experience in biotechnology or related field is desired, but not required.
  • Hands-on experience with paper and/or electronic Document Control Systems is desired.

Note: All job candidates must be authorized to work in the United States.

Benefits:

Include a competitive compensation and benefits package composed of health and dental benefits, 401k match, stock option grants, PTO, tuition reimbursement, a generous bonus plan and relocation assistance. At Invenra, we believe in maintaining the highest ethical standards and ensuring that all employees have a good work-life balance.

Invenra is an Equal Opportunity Employer. Invenra is committed to a diverse workforce. We believe every individual brings their own unique experience, and these experiences foster innovation and success. We are enthusiastically inclusive of age, race, creed, color, disability, marital status, sex, national origin, ancestry, sexual orientation, and military service.

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Invenra, Inc.

Address

Madison, WI
53719 USA

Industry

Technology

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