Specialist I, Quality Systems Position Available In Miami-Dade, Florida

Specialist I, Quality Systems BioTissue Holdings Inc Miami, FL Job Details Full-time Estimated:

$60.5K – $79.8K a year 1 day ago Benefits Stock options Health savings account AD&D insurance Paid holidays Health insurance Dental insurance 401(k) Flexible spending account Tuition reimbursement Paid time off Parental leave Employee assistance program Vision insurance Pet insurance Qualifications Microsoft Powerpoint Microsoft Word Power BI Microsoft Excel Management Data analysis skills Quality management GMP Mid-level Quality assurance Bachelor’s degree Data analytics 1 year Leadership FDA regulations Full Job Description Position Summary Responsible for documentation & QA activities as required in a GXP environment to include the preparation of non-conformance, error/deviation and customer complaint investigations as well as corrective and preventive action reports; general GXP functions such as data analysis & trending; identify, coordinate and resolve quality, process, technical and safety issues. Essential Duties & Responsibilities Perform quality assurance functions in a current Good Manufacturing Practice (cGMP) facility to maintain compliance with FDA, ISO, AATB and company standards. Perform documentation as required for a cGMP environment. Support record owners who are conducting investigations, prepare and/or review reports for non-conformances and change control events. Participate in corrective/preventive action brainstorming sessions, provide feedback and input, from a quality perspective, and assure the proper closure of all investigations. Receive and investigate (or assist in the investigation of) customer complaints, errors/deviations and adverse events/ HCT/P deviations. Perform data entry and data analysis for the functions mentioned in Items (above) for trending, reporting and continuous improvement initiatives. Perform data analysis on quality records. Support Quality and other teams to create and maintain quality metrics dashboards and perform trending and analysis. Use quality data to identify and communicate quality trends and continuous improvement opportunities. Perform general records maintenance and ensure compliance for all cGXP and QA records to ensure organization, traceability and retrieval. Work in tandem with the Production, Operations, Recovery, Supply Chain and Distribution departments to ensure quality output in all of the above areas. Provide cross functional project management support, either by initiating, leading, or participating in projects. Skills & Abilities Proficiency in the use of electronic quality management systems (e.g. MasterControl) Proficiency in data analytics and data analysis tools (for example, Power BI, Power Automate) Pays careful attention to detail. Uses observational and reasoning to troubleshoot, grasps concepts, patterns and underlying issues. Uses past experiences to help identify likely causes and solutions to problems that might otherwise seem to be unique events. Uses training and management skills to helps others see patterns and concepts by using examples and analogies that relate well to their own experience and current knowledge level.

Proficient in Microsoft software applications:

Excel, Word, PowerPoint and Outlook. Position Expertise/Qualifications Bachelors Biological, Chemistry, Biochemistry Science or related field Required 1 to 3 years of experience in Quality Management Systems or Quality Assurance functions Or 1 to 3 years of combined experience in GxP environment that may include Operations, Quality, Technical Support, Regulatory Affairs, Research & Development in ISO 13485, FDA and/or AATB regulated organizations. About BioTissue & our Culture At BioTissue, we transform the gift of life by sharing miracles. We are a diverse community, where talent and teamwork are core to who we are. Here, you are

EMPOWERED

to do the work you love, be yourself, and make an impact. Resilient and committed to our vision, we embrace challenges, celebrate courage, and take great pride in our work to create life-changing products. Purpose led us here. Passion and legacy keep us going. Total Rewards Health, Dental, Vision Insurance, 401 (k), FMLA, Health Saving Account (HSA), Flexible Spending Account (FSA), Basic Life and AD&D insurance, Voluntary Life and AD&D insurance, Disability, Employee Assistance Program (EAP), LegalShield / IDShield, Pet Insurance, tuition reimbursement, and Birthing & Parental Leave, Paid Holidays, Paid time off, MBO, Stock options. ADA Statement Candidates who cannot perform one or more of these requirements due to disability will be eligible for consideration based on whether the candidate can perform the essential functions of the position with a reasonable accommodation.