Piper Life Sciences is currently looking for a Quality Assurance, On the Floor in Kenilworth, NJ to work for a cutting-edge global biopharmaceutical corporation focusing on the discovery, development, and commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
Responsibilities for the Quality Assurance Opportunity Include:
- Draft, revise, review, route, and approve SOPs, Work Practices, Forms, and other type of GMP documentation deliverables
- Responsible for routing document deliverables through the Document Management system
- Assist in the writing of deviations, CAPAs, and Change Controls
- Responsible for periodic reviews of SOPs
- Regularly reviews, prioritizes and promptly responds to customer equipment maintenance, repair and support requests.
- Provides technical support and guidance on calibration and maintenance issues. Interfaces with customers to ensure expectations are being met.
- Maintains a positive relationship with all the members of the Equipment Commissioning & Qualification department and site customers while promoting a positive team environment.
- Keeps a log of documents and their states, including types, owner, reviewers, due dates, etc.
- Follows up with team members and cross functional team members to encourage timely review and approval.
Qualifications for the Quality Assurance Opportunity Include:
- Highly proficient in Microsoft Office Suite – Word, Excel, PowerPoint and Outlook with extensive background in database system
- Understands and works with all components related to web pages, i.e., web parts, lists, pages, libraries, permissions, content and forms
- Strong working knowledge in computer training systems
- Working knowledge of enterprise business systems such as Oracle or SAP
- Strong written and verbal communication skills
- Experience with technical writing and document development / generation
- Excellent interpersonal skills with experience dealing with a diverse workforce
- Strong multi?tasking ability in conjunction with proven organizational skills
- Familiarity with FDA and EU environments and associated compliance regulations
Compensation for the Quality Assurance Opportunity Includes:
- Compensation commensurate with experience and education
- Full Benefits: Medical, Dental, Vision, 401(k) plan, Holidays, PTO
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