Technical Writer Job in Pittsburgh 15220, Pennsylvania Us
This position provides regulatory support for blood collection activities, including error management, audits, standard operating procedures (SOPs) and validation to ensure product quality and optimal product collection. The Technical Writer supports the blood centers Technical Training function by writing, editing, producing, and maintaining procedural documentation including but not limited to department policies and procedures (SOP’s) and/or “how to” user guides and application guides. This Writer review and/or evaluate reports, documents, FDA regulations, and rules; edits, prepares, or approves summaries of findings. Beyond written documents, the Technical Writer also draws/creates graphic charts, working drawings, illustrations, maps for publications/displays or similar projects and adapts sketches/drawings to meet specific technical or publication requirements. They will analyze data, detect trends, determine where changes are needed and make suggestions for SOP improvements. As the functional expert, the Technical Writer reviews and coordinates the preparation of reports, papers, and presentations for management.
As part of the quality assurance activity, this position prepares the monthly Quality Indicator report for management review. This QA professional investigates and reports on error trends and their root cause. They would make suggestions regarding error prevention and participate in revising procedures to improve processes. This position collaborates with staff, management and technical training to prevent errors from occurring. This position reviews process improvement documentation to monitor procedural errors and deviations and communicates to management of any regulatory/cGMP deficiencies.
HS diploma or equivalent. Bachelor's Degree in Nursing strongly preferred. 5 years of relevant experience is required. Candidate must have demonstrated effective analytical and critical thinking skills; and the ability to problem solve, implement and evaluate effectiveness. Strong technical writing skills with experience in Word, excel and PowerPoint. Computer proficiency is required. 3 years of Blood Banking and 1 year of supervisory experience is preferred. Experience in regulatory compliance and procedural writing is strongly preferred along with quality assurance monitoring and route cause analysis is highly desirable.
ITxM is an equal opportunity and affirmative action employer that does not discriminate in employment and ensures equal employment opportunity for all persons regardless of their race, color, religion, sex, national origin, or status as a qualified individual with a disability or Vietnam era or other protected veteran. ITxM’s policy applies to all terms and conditions of employment.
We offer a competitive salary and an excellent benefit package that includes Medical/Dental/Vision Insurance, Short/Long Term Disability, Employee/Dependent Life Insurance, Flex Spending Options, 403(b) Retirement Savings (with company match), Tuition Reimbursement, Vacation/Sick/ Personal Days, and 6 Paid Holidays.