Alla Haney Email & Phone Number

Allentown, Pennsylvania Area

Allentown, Pennsylvania Area

♣ Create batch records and generate labels for commercial and clinical packaging♣ Review executed batch records and communicate with customers to resolve issues♣ Perform annual product review for the product packaged at Sharp Bethlehem site♣ Review analytical data for stability testing of finished product♣ Initiate change controls for SOPs, SOIs and MPIs♣ Perform GMP training of line personnel to improve BRFT of executed batch records

Bethlehem, Pa

♣ Reviewed executed batch records from Bethlehem site and contract manufacturing, and release in SAP♣ Created new labels using Easy Label system for commercial and clinical packaging♣ Set up QM in SAP for new packaging materials, drugs, and finished goods♣ Reviewed analytical data for stability testing of finished product and archived Laboratory Notebooks/LDRs on shared drive♣ Received the FY13Q4 S.T.A.R. award for releasing product in a timely manner, maintaining a positive attitude, and collaborating with customers and supply despite the unexpected departure of second QA compliance employee♣ Streamlined business processes and reduced the cost of stability testing, resulting in $40,000 of annual savings♣ Suggested time-saving procedures, which were implemented by company, reducing time by 4 hours per Annual Product Review

Bethlehem, Pa

♣ Executed incoming inspections of bulk drug and packaging components, and released in SAP♣ Performed production line clearance inspections prior to start-up of production ♣ Conducted packaging line audits and real time reviews of batch records to ensure adherence to SOP and GMP standards♣ Verified batch records and labels before releasing them for production runs♣ Performed the swabbing of packaging equipment for product residue and microbial contamination during the cleaning validation and clean hold studies♣ Conducted routine water sampling from the Purified Water System and analyzed results received from the laboratory

Bethlehem, Pa

♣ Performed real time review of batch records and supporting documentation for accuracy and completeness♣ Maintained and updated QIR daily, cleaning logbooks and metrics on a monthly basis♣ Contributed to a number of Kaizen team projects which successfully improved work processes and safety, and established key production performance indicators and quality improvements♣ Received numerous awards for exceeding increasingly challenging production targets without incidents

Bethlehem, Pa

♣ Verified batch records, labels, and related documentation prior to and after product runs while supporting operation needs during the set-up and start-up of production lines♣ Responsible for performing appropriate machine challenges based upon machine type and customer specification♣ Performed production line clearance inspections to prevent cross contamination♣ Possess knowledge of variety of equipment: bottle filling line, bottle line, tube printing line, carton line, pouches, folding machines, tube filling and sealing machines, and blister lines

Allentown, Pennsylvania Area

♣ Responsible for running production lines according to SOP and GMP requirements♣ Operated a variety of semi-automatic and automatic packaging equipment

Nikolaev, Ukraine

♣ Managed the daily operations of the work shop while supervising over 100 employees♣ Oversaw the reduction of labor input and product costs♣ Responsible for technological discipline control and correct operation of processing equipment