· Performed batch record review on production manufacturing documents as well as internal quality assurance and quality control documents.· Ensured that documentation is accurate, contemporaneous, and ensured data integrity of documentation which is required for external audits by clients and federal regulatory administrations such as the FDA/ Health Canada· Responsible for ensuring that quality is maintained throughout the production process, starting at the compounding stage going on through to the filling and packaging stages of generic pharmaceutical products, and making sure that these products are manufactured and packaged according to GMPs and established SOPs· Responsible for providing oversight and support in various quality activities such as in-process bulk testing, batch record review on line, Master Data maintenance, and Quality investigations· Responsible for the collection of cleaning validation sample and the coordination of production equipment being cleaned for production activities to remain GMP compliant· Coordinated with Production staff to ensure the quick and efficient turnover of production lines, including providing consent in starting production lines· Participated in Out of Specification Investigations and determined usage decisions based on Quality impact to product · Participated in the training process of new recruits

· Responsible for being primary company contact for customers and Territory Managers· Ensured prompt, accurate and complete responses to requests for product pricing, product delivery and logistical support for customers and Territory Managers· Reviewed customer purchase orders for product delivery and ensured the timely and accurate processing of orders and order acknowledgements to hospitals and clients· Worked closely with Field Sales Representatives and Regional Business Directors to advise them of potential customer issues and helped in meeting customer’s expectations and goals· Assists customers in fulfilling purchase order requirements, confirming order types and exceptions, and communicating with customers to ensure accurate and complete orders· Helped verify and manage certificates for approval for Neuro Pumps as per exceptions and Consent-Decrees laid out by the FDA and Health Canada in a compliance environment· Responsible for sales order creation and maintenance· Took part in LeanSigma projects to help optimize work flow processes and operations

· Performed tasks and functions involved in transferal of pricing and customer/ client contract data from existing pricing software into new pricing software.· Entering contract pricing information into pricing software for manipulation and analysis· Involved in database reconciliation of prices and clients between different pricing software· Identified and resolved problems with new software on existing company network to ensure faster and accurate through-put of data through pricing pipeline · Assisted in several tasks involved in cataloging of new users and helping/ teaching Territory Managers to use the new pricing software· Created SOPs on using the new pricing software to be used by multiple regions and geographies· Took part in Greenbelt LeanSigma projects to help optimize work flow processes and operations

· Involved in many aspects of regulatory affairs in a consulting capacity on submissions for clients· Involved in many quality assurance tasks including document validation as per Health Canada and FDA regulations and stipulations· Assisted in building regulatory and business proposals for several clients· Assisted in the formulation of various components of New Drug Submissions/ Applications for review by Health Canada and the Food and Drug Administration· Experience in preparing clinical trial results for eCTD format· Experience in formulating product license amendments

· Performed various functions in file management of a mid-sized law office:· Received and mailed out correspondence pertaining to many large cases between multiple legal firms, clients, and regional courts· Managed file tracking within the office and storage facilities· Optimized work processes reducing the entire backlog of correspondence that needed physical filing· Performed various tasks that increased productivity as a whole throughout the office

· Performed various functions in the distribution and logistics of medical technologies:· Picked, packaged, and labeled medical products meant for both patients and hospitals· Performed tasks regarding the importation of medical technologies:· Received products from international manufacturers and departments which would be organized and stored in warehouse· Developed good sense of customer service· Performed various functions integral to Quality Assurance and following GMPs and GDPs as well as implementing updates to the distribution processes as per directions of CAPAs made for distribution