Description:
Note:

• 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)]
• Experience with managing quality records
• Technical writing is a huge plus

Job Details:

• 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 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 peoples lives.

Basic Qualifications

• Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience.

• Experience owning Quality Records (Deviations/Change Controls)
• Experience managing Stability Programs/Studies
• Experience establishing/maintaining processes and procedures for sample handling and storage
• Experience with managing quality records
• Technical writing is a huge plus

• Responsibilities will include sample management and stability lab set up, writing procedures and reports and supporting lab analysts with initial lab equipment installation, qualification, and validation.
• Author, revise and review documents and reports including but not limited to SOPs, test methods, safety assessments, trend reports, qualification/validation summary reports, technical reports, method assessments, technical assessments, microorganism assessments.
• Assisting with procurement activities for consumables and critical reagents for lab start up.
• Assisting with Quality Records as needed to (OOS/OOT/OOE/Non-conformances, Deviations, and Change Controls) to support the QC lab start up/routine lab activities.