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GMP Manufacturing Associate NuPathe
THIS JOB HAS EXPIRED
This position reports to the Director of Technical Operations. The GMP Manufacturing Associate?s primary responsibility will be to work with the Operations and Quality Assurance team to coordinate and execute GMP activities within NuPathe. The candidate must have strong Good Manufacturing and Good Documentation fundamentals and must possess strong technical, writing, and investigational skills.Responsibilities
Perform GMP activities such as form and logbook entries, inventory control, drug room maintenance and general good documentation practices
Ensure consistency, completeness and adherence to FDA, ICH and ISO regulations
Write, revise, execute and adhere to NuPathe procedures
Assist in the closure of CAPAs, deviations and investigations
Provide ongoing support to all NuPathe departments as required
Conduct device testing, complete all associated documentation and coordinate document control activities
Interact with outside vendors/contractors regarding project activities
Coordinate shipments to and from contract organizations
Organize and create documentation systems to support Operations and Quality Assurance
Requirements
B.S. or equivalent in Life Sciences, Engineering or other similar technical field and 3+ years relevant experience in pharmaceutical or medical device
Working experience in a professional GLP or GMP laboratory environment
Strong documentation skills
Experience with device GMP regulations (part 820) is desirable
Awareness of the regulatory process is desirable
Must demonstrate strong verbal and written communication skills
Strong computer skills, MS Word, Excel, Access, MS Project and PowerPoint
| Location: | 375 East Elm Street Suite 110 Conshohocken, PA 19428 United States |
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THIS JOB HAS EXPIRED
NuPathe
Investors: Battelle Ventures, Quaker BioVentures, Safeguard ScientificsAll Jobs: at NuPathe
| Web Site: | www.nupathe.com |
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| Headquarters: | 375 East Elm Street Suite 110 Conshohocken, PA 19428 United States |
| Industry: | Biotechnology |
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