Quality Assurance Specialist II Job Details Level Experienced Job Location Boca Raton - Boca Raton, FL Position Type Full Time Education Level 4 Year Degree Salary Range Undisclosed Travel Percentage None Job Shift Undisclosed Job Category Pharmaceutical Description Performs a wide variety of Quality Assurance activities to ensure compliance with related regulatory requirements. Writes, revises, processes cGMP documents such as: Standard Operating Procedures (SOPs), Forms, and Testing & Production Records. May conduct investigations related to testing andmanufacturing of blood products. Ensure inspection readiness through QA oversight of RPSTO operations. Influence non-routine work practices through the application of quality methodologies to ensure required outcomes. Excercises judgement within defined procedures to ensure quality attributes of test results, including the quality of cGMP laboratory testing processes. + Understand the cGMPs and processes such as Quality Systems (e.g., Change Controls, Deviations, Corrective and Preventive Action reports (CAPAs), training, complaints, audits, etc. + Ensure cGMP and regulatory compliance as defined in government regulations such as 21 CFR Parts 11, 210, 211, and 600, as well as compliance with corporate policies and procedures. + Performs QA oversight of the Boca, RBC Processing and Specialty Testing Operations (RPSTO) manufacturing and testing operations, including, but not limited to, testing and manufacturing record reviews and inspections of testing/production area to resolve problems early and to ensure compliance with SOPs and regulatory requirements. + Perform review and release of immunogen Red Blood Cells (iRBCs) for shipment to BPC/Biomat Plasma Centers, as required. + Discus fundamental technical and regulatory issues, as well as resolve and negotiate quality related issues, as needed. + Write and revise QA SOPs including developing new procedures. Review SOPs and documents in revision for accuracy and completeness. + Assist with new employee and on-going cGMP and quality related training as required. + Perform constructive investigations and assist with discrepancies and non-conformances. + Work on problems ofmoderate scope where analysis and situations of data requires a review of a variety of factors. + Review change control records to ensure all critical steps are completed prior to QA release. + Assist with investigating and addressing deviations (including temperature deviations) in a timely manner. + Ensure general laboratory equipment is acceptable for production use by performing verifications as needed. + Assist with internal and external audits. Coordinate corrective actions to address audit findings and observations. + Review equipmentqualifications and executed protocols for instrumentation to be used in production. + Review and approve critical testing reagents / kits for use in production. + Review and approve calibrations and verifications performed on testing and general laboratory equipment ensuring acceptance criteria is met. + Accurately complete detailed documentation as required by established procedures and good documentation practices (GDP) regulations. + Effectively communicate withpersonnel from various departments and escalate to management as required. + Coordinate and perform anyadditional activities or project assigned by Management Qualifications Education Requirements: Bachelors Degree in a Science related fields highly preferred but can be offset by experience. Experience Requirements: Typically requires at least 3-5 years of practical experience working as a professional in a cGMP pharmaceutical or biotechnology regulated environment. Other Essential Knowledge: Detail oriented, and has knowledge of scientific, medical and regulatory terms. Ability to use personal computer and software including word processing, spreadsheet and database. Demonstrated organizational and coordination skills, with close attention to detail and accuracy. Good inter-personal and oral communication skills to effectively train personnel. Demonstrated good problem solving skills with minimal supervision. Mathematical skills including the use of calculations involving fractions, decimals and percentages.