Piper Companies is currently looking for a Quality Assurance Shop Floor Specialist in Summit, NJ to work in a growing and innovative bio pharmaceutical manufacturing company
Responsibilities for the Quality Assurance Shop Floor Specialist Include:
- Draft, revise, review, route, and approve SOP's, Work Practices, Forms, and other type of GMP documentation
- Responsible for routing document deliverables through the Document Management system
- Assist in the writing of deviations, CAPA's, and Change Controls
- Responsible for periodic reviews of SOP's
- 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 Shop Floor Specialist 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 Shop Floor Specialist Includes:
- Compensation commensurate with experience
- Full Benefits: Medical, Dental, Vision, 401(k) plan, Holidays, PTO
Quality assurance, Shop Floor, Specialist, QA, QC, quality control, GCP, GMP, CGMP, FDA, regulatory, quality management, pharmaceutical, pharma, combination device, biotechnology, regulatory, benefits, vacation, holiday, 401(k)