Unique opportunity for a professional Quality Assurance Coordinator to join our innovative Bioscience company. We provide research-based tools for Cell & Gene therapy and Regenerative medicine sectors. In this crucial role you will maintain the highest level of quality control, knowledge and understanding of the innovative operations in the ever expanding world of Bioscience.
The Coordinator will be responsible for all the daily Quality Assurance activities regarding the Quality Management System, including but not limited to:
Document Controls Vendor Management Materials Management Training Manufacturing Auditing Testing Non-Conformances Packaging Change Controls Labeling Equipment Facilities Regulatory Controls
In this role the QA coordinator will remain compliant with corporate Standard Operating Procedures as well as Regulatory requirements.
- Act as Point of Contact/Subject Matter Expert on all QA matters, both internally & externally. Assist in the design of phase appropriate QA systems from implementation to continuous improvement & development. Write, review and/or approve master and executed phase-appropriate documentation, including production records, testing records, non-conformances, investigations, reports, protocols change controls, SOP’s etc.
- Prepare Lot release documents, including certificate of testing or analysis for final management approval. Ensure resolution of all identified issues prior to Lot disposition (e.g. investigations, deviations). Act as first responder for all on-site quality issues in a timely manner, assists in the documentation of events and in identifying required containment /corrective actions & methods. Develops appropriate risk management strategies and assists with implementation Review and approve Assay qualification/validation test plans and summary reports Review equipment records. Provide Quality related training to company personnel.
- Collaborate and lead discussions with other managers to ensure all deliverables meet the needs across the organization Perform “Real Time” documentation review, concurrent with operations. Participate in cross-functional team meetings where QA oversight/input is required. Facilitates issue resolution through problem-solving and colleague collaborations. Consistent use of independent decision making skills, precise judgement and highest level of discretion. Perform and support routine Quality area walkthroughs and audits. Collaborate with Production and R&D to review, optimize and/or develop validation protocols.
- Ensure compliance of all product labeling and advertising. Stay current with all regulatory procedures and documentation. Maintain compliance with phase appropriate requirements. Work independently under general supervision and direction. Perform other related duties as assigned
- Bachelor of Science degree in Life Sciences or related field is preferred. 4+ years of experience in the pharmaceutical, biotechnology, device and/or tissue/blood bank.
- Knowledge of standard tissue culture and immunological/virological techniques including aseptic techniques, cell line maintenance, western-blot, ELISA, flow cytometry, etc. Knowledge of FDA and EU regulations (21 CFR 210/211, 1271, 2001/81/EC, 2006/17/EC and 2006/86/EC )
- Fluency with Microsoft Office software applications (Word, Excel, PowerPoint, SharePoint, Email). Knowledge in design and deployment of QA programs Ability to solve complex technical issues and manage multiple priorities Excellent organizational, communication and writing skills Must be Fluent in English, multiple languages welcomed Ability to effectively maintain files and active records
We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race ,color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status and will not be discriminated against on the basis of disability.
Offering a competitive salary and company benefits. Candidates offered employment must be vaccinated for Covid-19 or secure approved accommodation prior to the commencement of employment to support the well-being of everyone on premises.
Boca Raton, Florida