Quality Systems Specialist in Wilson, NC at Apex Life Sciences

Date Posted: 2/13/2018

Job Snapshot

Job Description


Apex Life Sciences is seeking qualified candidates for a Quality Systems Specialist in Wilson, NC!

Position:  Quality Systems Specialist

Position Description:

We are seeking an experienced Quality professional knowledgeable in developing, communicating, and maintaining a quality plan to maintain the Quality System.  This individual will be responsible for ensuring site compliance with regulatory requirements in our GMP and ISO/IEC 17025 environment.  The Quality Systems Specialist will promote quality achievement and performance improvement throughout.  

Responsibilities include, but are not limited to:

  • Manage new project/product execution for Quality related functions
  • Ensure compliance to applicable regulations (cGMP, ISO/IEC 17025, OSHA)
  • Develop and perform cGMP and ISO/IEC 17025 training
  • Hire, train and coach Quality personnel
  • Manage the document and record control process
  • Perform record review and finished product release process
  • Support the process for execution, investigation and documentation for deviations, OOS, complaints and non-conformances
  • Lead the overall CAPA program to include investigation, root cause analysis, corrective and preventative actions and documentation
  • Conduct internal audits; determine and execute the corrective actions
  • Conduct customer/ regulatory audits; determine and implement effective corrective actions
  • Write and implement required SOP’s and work instructions
  • Identify and implement continuous improvement ideas
  • Maintain database as needed to support the Quality Management System (QMS).

Minimum requirements:

  • Requires a bachelor’s degree in a science or business field or equivalent work experience.
  • Prior experience (3 years or more) in Quality Assurance or Quality Control
  • Flexible and adaptable to changing environments and situations
  • Knowledge of cGMP regulations (preferably 21 CFR part 111) and ISO/IEC 17025
  • Proficient in Microsoft Office: Word, Excel, and Power Point, MS Access
  • Confident decision maker, owns responsibility for outcomes
  • Delivers tasks and deadlines, meeting all deadlines
  • Able to prepare and present information in a presentation format
  • Able to communicate directives to others in a positive or proactive manner
  • Proactive in finding and implementing new solutions
  • Ability to write technical report, taking facts and information and assembling them into a logical report with well supported conclusions and summaries (i.e. Crystal reports)
  • Experience with database development and system integration
  • Experience with Laboratory Information Management Systems (LIMS)

If interested in this role please send your resume to Raleigh@ApexLifeSciences.com