Quality Assurance Validation Specialist
Somerset, New Jersey
Our company is a niche pharmaceutical company that develops, manufactures and markets generic and branded prescription pharmaceuticals as well as animal and consumer health products. We specialize in difficult-to-manufacture sterile and non-sterile dosage forms including: ophthalmic, injectables, oral liquids, OTCs, topicals, inhalants, and nasal sprays. The company markets its products to retail pharmacies, ophthalmologists, optometrist, physicians, veterinarians, hospitals, clinics, wholesalers, distributors, group purchasing organizations, and government agencies.
The Quality Assurance Validation Specialist is an adept technical writer/editor and the use of desktop Office applications. The QA Validation Specialist must become familiar with site databases and proficient in the retrieval and presentation of information. The QA Validation Specialist will trend this information using the graphical features of Microsoft Excel and Minitab and display these in Microsoft Word reports. A major example is the Annual Product Review (APR).
In addition the QA Validation Specialist will lead in Change Control decisions and work with other departments to identify and solve issues that impact the product validation or the regulatory state. The QA Validation Specialist not only works with all site departments but supports Corporate Regulatory and R&D needs as well. The QA Validation Specialist will support Regulatory Affairs with technical writing as pertaining to equipment and processes for product submissions and Request for Information (RFI). The QA Validation Specialist will provide project support for the New Product launches and utilize Microsoft Project to organize site deliverables.
Additional responsibilities may include assisting with validation activities associated with equipment and/or processes. The job may require travel to vendor sites to complete Factory Acceptance Testing in order to accept equipment for the site. Expect travel of less than 10%.
Education and Experience
Minimum Bachelor’s degree in a technical or pharmaceutical related field is required. A degree in engineering in preferred. Minimum 5 years pharmaceuticals or 2 years direct experience.
Proficient in Microsoft Word, Excel, and Trackwise. Experience with Minitab and Project is a plus.