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Specialist Quality Control

Holly Springs, NC


  • 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.

Top 3 Must Have Skill Sets:
  • 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

Day to Day Responsibilities:
  • 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.

Pay Rate  between $37 - $42/Hr on W2 based on experience.

"This posting is for Contingent Worker, not an FTE"

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