Associate Metrologist II
About The Position
Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position The Associate Metrologist II owns routine support tasks for the Metrology team, particularly involving advanced workflows in BMRAM and Veeva. This includes asset onboarding, executing change controls, deviations, and creating or updating work instructions and asset records.
Requirements
- Bachelors degree in a technical or scientific discipline or equivalent experience.
- 3+ years of experience in calibration, metrology, or GMP operations.
- Familiarity with quality management systems like Veeva and calibration software like BMRAM.
Nice To Haves
- Experience with creating Work Plan Templates and Measurement Data Templates in BMRAM
- Experience with asset management reporting and compliance metrics
Responsibilities
- Independently complete routine workflows in Veeva and BMRAM, including:
- Asset and hierarchy creations in BMRAM
- Maintenance event creation and schedule assignment for new assets
- Deviation entries and tracking
- Work instruction creation for simple procedures and revisions for complex procedures
- Change control documentation and change action execution for simple changes
- Coordinate asset status updates and documentation.
- Troubleshoot standard issues and escalate complex problems.
- Support vendor execution or author and execute of qualification protocols for standard laboratory instruments. Track and coordinate protocol event resolution.
- Author qualification reports following standard templates.
- Investigate root cause of simple maintenance and calibration deviations. Recommend and complete improvement action items.
- Develop recommended maintenance plans and spare parts lists for new equipment with guidance from engineering and vendors. Work with vendors to develop parts and service quotes as required.
- Create electronic equipment files for new equipment based on equipment turnover packages
- Maintain organized electronic and paper records in compliance with GMP.
- Other duties as assigned
Benefits
- Arrowhead provides competitive salaries and an excellent benefit package.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
