Piper Companies is currently looking for a QC Technical Writer in Summit, 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.
QC Tech Writer deliverables:
- Write and execute methods, protocols, and reports
- Establish KPIs and metrics for analytical test data.
- Identify SOP inconsistencies and flag issues to senior leadership.
- Execute investigations and deviations for analytical data.
Responsibilities for the QC Technical Writer 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 QC Technical Writer 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 QC Technical Writer Includes:
- Compensation commensurate with experience and education
- Full Benefits: Medical, Dental, Vision, 401(k) plan, Holidays, PTO
Please send all qualified resumes to Karen Pallone at firstname.lastname@example.org
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