QA Associate, Document Control
QA Associate, Document Control
San Diego, CA
https://www.arenapharm.com/ is driven to deliver novel, transformational medicines with optimized pharmacology and pharmacokinetics to patients globally. Arena's proprietary pipeline includes multiple potentially first or best-in-class assets with broad clinical utility.
We are seeking a QA Associate, Document Control to support the Document Control department under Quality Assurance through the maintenance of records and GxP controlled documentation generated by Arena Pharmaceuticals, Inc. and external Contract Organizations. This individual is responsible for maintenance of the document management system (paper and electronic) and serves as a liaison for document control needs across GxP departments.
What you'll dive into:
• Support management of paper records (onsite/offsite) and electronic records within the Veeva Electronic Document Management System (EDMS).
• Manage the receipt and filing of documents from internal users and external contract organizations.
• Maintain and secure records, logs, files, forms and other Document Control inventory.
• Manage document archives and offsite storage (i.e., scanning, vendor management) including organization, archival, storage, and retrieval.
• Scan, upload and verify quality documents into the EDMS and other GxP Repositories, e.g., validation protocols, scripts, etc.
• Support creation, revision, and control of governance and procedural documents, including formatting and completion of workflow steps within the EDMS.
• Facilitate periodic review of procedures via reports in the EDMS and following up with assigned reviewers.
• Provide training for use of the Veeva EDMS. Assist with user questions related to use of the Veeva EDMS.
• Organize and provide documentation during audits and inspections by government agencies and other external bodies.
• Maintain metrics and monitor and report on QA Document Control status and milestones to management on an as-needed basis.
• Author, revise, and review procedures related to Document Control processes.
• Other duties as assigned.
What we expect:
• Knowledge of GxP (GCP, GLP, GMP) regulations related to records management and retention.
• Understanding of the expectations of the document lifecycle in a GxP regulated industry.
• Communicate effectively, verbally and in writing.
• Demonstrate good interpersonal skills with internal customers and with external contract organizations.
• Identify and implement continuous improvement projects related to document control.
• BS degree or equivalent experience of 3+ years of document management in a GxP regulated industry.
• Experience with Veeva (QualityDocs) EDMS is highly preferred.
What you'll get:
• To be a part a growing company and fantastic team passionate about developing novel drug therapies to improve people's lives
• Opportunities to learn and contribute creative solutions
• Comprehensive health insurance
• Matching 401k retirement plan
• Paid time off and holidays
• Company celebrations
Arena celebrates and supports our differences and is proud to be an Equal Employment Opportunity and Affirmative Action Workplace. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Arena is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance due to a disability, you may contact us at mailto:firstname.lastname@example.org.
By submitting a resume for consideration, applicants verify that they have read Arena's Applicant Personal Information https://www.arenapharm.com/applicant-personal-information-privacy-notice/.
To apply, visit https://apptrkr.com/2372352
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