Position Title: Senior QC Associate
Work Location: Holly Springs, NC, 27540
Assignment Duration: 6 months (Possible Extension)
Work Schedule: Standard weekday schedule
Work Arrangement: 100% onsite
 
Position Summary:

• This position will be part of the Quality Control Deviation and Change Control team for start up and operations of the ANC facility.

 
Description:

• The ideal candidate will have at least 1 year of experience working in a GMP-regulated lab or manufacturing setting, with a strong background in writing and owning quality records such as deviations, CAPAs, and change controls.
• Experience using the Veeva Quality system is highly desirable. This individual must demonstrate strong communication and grammar skills, a working understanding of QC laboratory processes, and the ability to lead meetings and drive investigations independently.
• Candidates must be proactive, detail-oriented, and capable of contributing in a fast-paced environment with minimal oversight.

 
This position will be part of the Quality Control Deviation and Change Control team for start up and operations of the ANC facility.

• Working collaboratively with Quality and Quality Assurance teams to author and own change control records and deviations in the DQMS Veeva System
• Individual will lead investigation teams and help to collect and report metrics for the systems team
• Individual may assist with review of validation documents to support equipment and computerized system onboarding.
• Individual may 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.
• Support the startup of a GMP QC laboratory.
• Support routine activities over the weekends and public holidays as required.

 
Top Skill Sets:

• Deviation and Change control writing experience
• Veeva system experience
• Leadership capabilities - must be able to lead meetings, drive investigations.
• Hiring manager is focused on practical aptitude and writing skills. Strong writing and grammar skills.
• Collaborative and proactive.

 
Day to Day Responsibilities:

• Working collaboratively with Quality and Quality Assurance teams to author and own change control records and deviations in the DQMS Veeva System
• Individual will lead investigation teams and help to collect and report metrics for the systems team
• Individual may assist with review of validation documents to support equipment and computerized system onboarding.
• Individual may 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.
• Support the startup of a GMP QC laboratory.
• Support routine activities over the weekends and public holidays as required.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 38.00/hr.