**Remote for now BUT will eventually be an onsite role at Holly Springs, NC (must be in driving distance as they will eventually be required to go onsite)]
***** capped bill rate of ***/hour
**Experience with managing quality records
**Technical writing is a huge plus
The Quality Control Specialist will be supporting the Quality Control Organization. The environment is challenging, fast-paced and ever-changing with varying degrees of process definition, but very rewarding for those who like hands-on science and want to make meaningful improvements in the QC space.
Key Responsibilities may include:? Report, evaluate, trend and approve analytical data.? Troubleshoot, solve problems and communicate with stakeholders.? Generate complete, accurate, and concise documentation using electronic systems and laboratory notebook.? Participate in audits, initiatives, and projects that may be departmental or organizational in scope.? Execute protocols and perform assay transfer/validation and equipment qualification/verification.? Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.? Providing and communicating results, maintaining/operating specialized equipment and drafting and revising documents such as Analytical Methods, SOPs and technical reports.? Collaborate cross-functionally to drive the efficient transfer of technologies and to ensure appropriate execution of procedures and processes.? Support introduction of new methods/techniques into the lab.? Perform complex assay and instrument troubleshooting.? Responsible for CEMS on call pager.? May participate in lab investigations.? May provide technical guidance.? May train others.? May represent the department/organization on various teams? May interact with outside resources
Preferred Qualifications ? Knowledge of analytical methods commonly used in the quality testing of Pharmaceutical Biologics? Theoretical and practical knowledge of applying and developing separation and mass spectrometric methods for characterizing biologics? Proven record of scientific technical writing skills as demonstrated by peer-reviewed publications in science and technology journal? Experience and knowledge of Data Integrity Requirements of QC Systems? Proficient in Microsoft Office (e.g. Outlook, Word, Excel, PowerPoint)? Excellent problem-solving capabilities and attention to detail? Experience of collaboration within and across functional areas and outstanding customer service focus? Excellent written and verbal communication skills*** is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.*** focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people?s lives. A biotechnology pioneer since 1980, *** has grown to be one of the world?s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential
