Senior Associate Quality Control

Aditi Consulting

  • Holly Springs, NC
  • Permanent
  • Full-time
  • 8 days ago
Payrate: $35.00 - $38.00/hr.Summary:
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 changing 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.Responsibilities:
  • Working collaboratively with Quality and Quality Assurance teams to author and own change control records and deviations in the DQMS Veeva System
  • Individuals will lead investigation teams and help to collect and report metrics for the systems team
  • Individuals may assist with a review of validation documents to support equipment and computerized system onboarding.
  • Individuals 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.
Must Have Skills:
  • Deviation and Change control writing experience
  • Veeva system experience
  • Leadership capabilities - must be able to lead meetings, drive investigations.
  • The hiring manager is focused on practical aptitude and writing skills. Strong writing and grammar skills.
  • Collaborative and proactive.
Pay Transparency: The typical base pay for this role across the U.S. is: $35.00 - $38.00/hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy ( ).Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions. By applying for this position, you agree to Aditi’s use of AI technology, including calls from an AI Voice Recruiter.#AditiConsulting
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Aditi Consulting