Aaron Bittner Email & Phone Number

Albany, New York Area

• Acts as a liaison between the Facilities Department and onsite quality and regulatory groups to define and address all issues of non-compliance.• Provides support, information, and assistance to individual groups and supervisors with the initiation, review, submission, and follow-up of documents such as event investigation records, impact statements and corrective action plans. • Participates in investigations and root cause analysis for all Facilities Department issues of non-compliance.

Wilson, Nc

In this salaried position at Sandoz’s Wilson plant, I am part of a team of in-process Quality Assurance professionals who perform product inspections, perform post-clearance inspection of packaging lines, manage product holds and destruct orders, take part in quality event triages, and generally ensure quality, compliance, and safety in production operations.

Wilson, Nc

In this salaried position at Sandoz’s Wilson plant, I led a team of investigators for the Pharmacy and Granulation business unit. I monitored deviation-related metrics for my business unit and reported them to site governance. I performed training and communicated deviation information to line personnel to ensure awareness of quality issues on the manufacturing floor. I performed root cause analysis for manufacturing deviations, authored investigation reports and other documents, and devised effective CAPA tasks for issue remediation. I was a dedicated resource for investigations that were complex or time-sensitive.

Wilson, Nc

I perform and document Manufacturing investigations, and help to ensure compliance with standard operating procedures, FDA regulations, and cGMP manufacturing practice at Sandoz's Wilson, NC plant.

In this role I track the completion of corrective action/preventive action (CAPA) tasks resulting from exception reports. I administer investigations in the plant's exception tracking software, and I train personnel on the use of our new TrackWise exception tracking software, due to go live this summer.

As one of a team of investigations coordinators at Hospira’s Clayton plant, I investigate deviation events in manufacturing and administer the tracking of those events in the company’s CAPA system. I help to develop corrective and preventive actions to address quality issues and maintain cGMP. I advise and train junior members of the investigations team. I work closely with Quality, Validation, Manufacturing, Documentation, and Regulatory to ensure product quality and regulatory compliance.

In this salaried position, I supervised the packaging line for small-volume IV pharmaceuticals. I worked with personnel, equipment, and documentation to maintain production quality and output. I was an Event Owner in the company’s CAPA system, and continued to handle some product-related exceptions.

As the investigations coordinator at Hospira’s Clayton plant, I investigated product and process-related exceptions in manufacturing. I wrote Exception Reports and developed corrective and preventive actions to address quality issues and maintain cGMP. I was an Event Owner in the company’s CAPA system, and worked closely with Quality, Validation, Manufacturing, and Documentation to ensure and improve product quality.

As a contract documentation specialist in Hospira's R&D/New Products department, I created and updated the standard operating procedures (SOPs) to operate a new production line for IV pharmaceuticals. I reviewed batch records, conducted investigations, wrote investigation reports and memos to file, compiled aNDA documentation, created and edited Module 3 CTDs, provided plant support to Regulatory submissions to FDA, facilitated communication between project team members, and created final product Certificates of Analysis from stability batch records. I performed many project management tasks associated with new product transfer.

In this contractual position, I managed the writing and editing of manuals for software applications. I worked with ABB's DIS division to produce output in print, PDF, HTML, and embedded Windows helpset formats using Adobe FrameMaker and Webworks Publisher. I estimated and scoped potential projects for my employer, and supervised two writers performing documentation-related tasks.

In this salaried position, I researched and wrote healthcare-related copy to be used in a newsletter published by Blue Cross and Blue Shield of Rhode Island, and I tailored that copy for specific individuals using the Micromass Communications model. I also edited other writers' work in a peer-review process, incorporated others' peer-review edits into my own work, and performed other writing tasks as assigned.

In this contractual position for TPS, I edited technical documents in HTML and XML for online use through Cisco's TACWeb division. The documentation consisted of user guides and bulletins for users of Cisco's network hardware and software products. My primary tool was XMetal.

In this contractual position onsite with QVC, I assessed the condition of returned home computers, decided whether to restore them to as-new condition for resale, and performed the required restoration. I worked with computer hardware and software.

In this contractual position onsite for ABB, I wrote and edited technical documentation, single-sourced technical documents for print and hyperlink-enabled PDF files, and developed and implemented procedures for migrating the existing document base from MS Word to FrameMaker. I supervised a junior-level writer at these same tasks.

In this contractual position onsite for EMC, I built JavaHelp help sets and other forms of hypertext online help, plus paper documentation in support of software products. I used JavaHelp, FrontPage, FrameMaker, WebWorks Publisher, and Interleaf Quicksilver in this position.

In this contractual position onsite with Scriptorium Publishing, I wrote user manuals and other documentation for both print and online use, primarily in support of third-party software products. I used FrameMaker, WebWorks Publisher, and various Adobe Acrobat applications in this position.

In this salaried position, I wrote and edited promotional and technical copy for individually tailored web pages and mass mailings, researched and wrote internal documentation and training materials, and performed testing and troubleshooting of applications built with Micromass’s proprietary object-oriented multimedia tailoring software.

In this contractual position onsite with MicroMass Communications, I wrote and edited promotional and technical copy for individually tailored web pages and mass mailings. This involved writing text, HTML code, and code for MMC Studio, Micromass’s proprietary multimedia tailoring software.

In this contractual assignment onsite with SAS, I managed book projects and acted as liaison between book authors, the SAS Marketing Department, and various book production personnel. I oversaw books from initial concept through final printing. My primary role was to take over the duties of another editor who was on maternity leave.

In this contractual assignment onsite for Nortel, I wrote, edited, and produced a user manual for ToolTime, an intranet-based application for time tracking, billing, and budgeting. I started with a partial design specification, copies of design team memos, and access to the application prototype under development, and produced a complete user manual.

In this salaried position I edited and organized technical manuscripts for publication. I edited copy, managed illustrations, resolved editorial questions with authors, and oversaw manuscripts through the pre-press process.

Ba, English

Activities and Societies: University Choir, Forestry Club

Bachelor Of Arts (B.A.), English Language And Literature, General