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Astellas Pharma QC Technician, Sample Management in South San Francisco, California

QC Sample Management Technician, Operations

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. For more information, please visit our website: www.astellasgenetherapies.com

About Astellas

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website at https://www.astellas.com/en.

Our Values:

  • Be BOLD (Find a Way)

  • Care Deeply -- for our patients, each other and our work

  • #GSDR (Get Stuff Done Right)

What is the catalyst for you in your professional career? Are you ready to be a part of a bold, innovative company, to make a change and to make a difference? Listed below is a current opening for a smart, driven, experienced, and just plain nice individual who wants to join us and be a part of our journey.

The Role

We are looking for a self-motivated candidate to join the Operations Group within the Quality Control Department to support QC sample management area. The successful candidate will assist a rapidly growing department with multiple tasks related to the day to day operations of the group. The candidate is expected to assist with the generation of labels for multiple sample types, assist in the creation of Contract Testing Service (CTS) Data Packets and CTS testing plans, aid with the retrieval of samples for QC Analytics and QC Microbiology testing, help with the organization of samples in all storage locations, along with other tasks related QC Operations. Must have demonstrated track record of ability and initiative to work independently and in a collaborative team-oriented setting in line with the vision/mission of the core group. The position will be in our offices in South San Francisco, CA.

Primary Responsibilities

  • Oversee receiving, inventory and distribution of lot release, non-routine and stability samples from manufacturing

  • Help maintain documentation and insure accurate records of inventory activities

  • Assist with the shipping of samples to out-sourced testing sites

  • Support with the creation of certificate of analysis data packets associated with out-sourced testing

  • Perform QC Support task -- e.g. equipment cleanings, sample inventory audits and Quality Operation logbook reviews

  • Maintain Quality Operations supplies inventory by checking; anticipating needed supplies; placing and expediting orders for supplies as needed

About you

Must Have/Required

  • BS or BA degree in Biological Science or other relevant degree, with a minimum of 0-2 years of relevant industry experience, in a quality control role preferred but not mandatory

  • Excellent project management and organizational skills, with attention to detail

  • Excellent oral and written communication skills. Ability to communicate professionally with vendors, internal customers and sales professionals regarding quality issues

  • Outstanding interpersonal skills, highly collaborative within a multi-discipline team and contribute to a supportive and positive work environment

  • Proficient at Microsoft Excel and Word

  • Dedicated and self-motivated and engaged to learn new methodologies or provide recommendations for optimization

  • Must be willing to work second shift, rotating shifts, overtime, weekends, and holidays, as required

  • Models our Core Values: Be Bold, Care Deeply, #GetStuffDone -- is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted

May Have/Preferred

  • Knowledge of Good Document Practices (GDP) or good documentation skill

  • Experience in a small company and high growth, fast-paced environment

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.

#LI-LK

Category Sales Operations

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

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