QA Specialist I

Location
Emeryville, CA, United States
Posted
May 12, 2019
Ref
odIH9fwv
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
COMPANY DESCRIPTION

At Santen, we're innovating therapies to improve the quality of life for patients worldwide. Our single focus in ophthalmology enables us to challenge unmet needs in the field-through passionate research, successful collaboration, and clarity of commitment. With over 130 years of investigative insight, Santen remains committed to the discovery, exploration, and development of ophthalmic therapies. As a global company, Santen is expanding to accommodate new and evolving initiatives in ophthalmic research, regulatory management, production, marketing, or distribution. Our clinical development network spans three continents, with centers in Europe, Japan, and the United States.

We are in search of top talent to help us meet our aggressive and important goals.

PRIMARY PURPOSE OF POSITION

This position serves as Santen Inc's Subject Matter Expert and Business Administrator for one or more Quality or Pharmacovigiliance systems and supports GMP clinical and commercial Quality operations and product release for Santen Inc.

JOB DESCRIPTION

We are looking for an individual capable of performing the major duties of the position as given below.

MAJOR DUTIES OF POSITION:
  • Act as Business Administrator and Subject Matter Expert for key systems as needed (Veeva Quality Documents, TrackWise, LMS, Etc.).
  • Participate in global teams to configure and manage systems. Identify system capabilities and improve efficiencies.
  • Identify and recommend duties for key system users worldwide, advise on or prepare key user training materials and train key users as needed.
  • Provide training to users and ensure completion prior to access rights being granted.
  • Assist functional areas to properly and consistently manage workload in the systems and be an advocate for system use, improvements, and upgrades.
  • Support computer system validations and document review as needed.
  • Review and approve master manufacturing/packaging batch records, labels, specifications, protocols, test methods, executed manufacturing/packaging batch records, investigations, and temperature excursions for clinical and commercial products
  • Manage GMP/GCP audit scheduling and audit report closure
  • Manage Quality Agreement drafting, approval, and expiration
  • Support GMP manufacturing at CMOs as necessary
  • Assist in the preparation, conduct and post-inspection stages of regulatory authority inspections.
  • Prepare monthly quality reports with assistance from other QA members.
  • Gather Management Review data and assemble with assistance from Inc QA functional lead.
  • Participate in Quality Compliance department meetings, prepare, distribute and post meeting agendas/minutes, and related materials.

KNOWLEDGE AND SKILL REQUIREMENTS:
  • Bachelor's degree, plus 3 years Quality Assurance experience. .
  • Experience with review and release of pharmaceutical drug products
  • Experience negotiating Quality Agreements
  • Experience with electronic document and investigation systems
  • Experience with Veeva Quality Docs, and TrackWise preferred
  • Computer system validation experience.
  • Superior organizational skills.
  • Excellent attention to detail.
  • Advanced skills in spreadsheet development.
  • Excellent Microsoft Office skills.