Associate II, Quality Assurance at Astellas Pharma

  • Manufacturing/Mechanical Jobs, Quality Assurance Analyst Jobs
  • Permanent Employment
  • 2 months ago
  • California, America
  • Shift Full-Time
  • Job Qualifications None
  • Job experience Fresh

Job Description

Associate II, Quality Assurance at Astellas Pharma

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, 

About Astellas Gene Therapies

Astellas Gene Therapies is an Astellas Center of Excellence developing genetic medicines for patients with rare, life-threatening diseases. Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for their newly-created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina. 

The Role

The primary purpose of the Quality Training Associate is to create, edit and manage the content of the Learning Management System (LMS) to ensure seamless customer experience and support for the users. This role will assist in identifying and implementing improvements that will maintain and enhance training effectiveness. This position will partner closely with functional SMEs to create and assign GMP training materials and report directly to the Sanford QA GMP Training Leader.

Primary Responsibilities

  • Execute the day-to-day operation of the LMS in accordance with Astellas policies and procedures

  • Provide efficient and timely customer service, ensuring relevant requests and documentation are processed appropriately

  • Liaise with functional area management to identify employee technical training needs and expectations and design appropriate training curricula and assignments

  • Partner with functional areas to monitor training compliance, effectiveness, and trends

  • Represent the Training function in reviewing GMP procedural documents, training materials, and executed training records to ensure required standards are met

  • Work closely with functional SMEs to create and assign GMP training materials and assessments that build general and technical process expertise

  • Track incoming requests for training, processing of training records, review of procedures, and updates to training materials

  • Update GMP training materials, as needed, to reflect current practices, regulatory requirements, and industry trends

  • Assist customers with the operation of the LMS and troubleshooting of system and content functionality

  • Identify and implement process improvements to guarantee training effectiveness and personnel qualification

  • Support regulatory inspections and internal audits

  • Performs other duties as assigned or special projects as needed

Organizational Context:

  • This position reports to the Assoc. Director, GMP Training (QA).

  • This position is an individual contributor role that requires onsite work.

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