Kelly Scientific is searching for (2) skilled Sr. QA Specialists to support a biopharma customer advancing novel gene therapies from concept to commercialization. Located in the heart of Columbus, OH and 100% onsite.

Job Title: Senior QA Specialist, QA Investigations/CAPA
Location: Columbus, OH
Rate: $35/hr.
Shift: 8am-4:30pm | Mon-Fri
Length of Assignment: 6 months

Job Description:
The Senior QA Specialist is an individual contributor role primarily responsible for conducting technical quality compliance-related activities in accordance with GxP regulations and internal SOP. This SME ensures deviations are thoroughly investigated, the root cause is determined, and appropriate corrective actions are identified and implemented.
 

• Oversee and support the prompt evaluation, investigation, closure, and follow-up of unplanned events as well as identify opportunities for continuous improvements.
  

• Works with SMEs to ensure thorough root cause analyses, assess impact to SISPQ, and ensures root cause is addressed through appropriate Corrective/Preventive Actions.
  

• Works to establish appropriate ownership and timelines for CAPAs about the risk related to the event or issue.
  

• Assesses final supporting documentation to complete/close CAPAs as adequate.
  

• Conducts CAPA effectiveness checks for high-risk events.
  

• Communicates critical metrics regarding deviations and CAPAs and chairs the Investigation Review Board meeting.
  

• Provide oversight and input to Trend Review Reporting and Lifecycle Review activities to identify and address process shifts and trends.
  

• Acts as the SME and trainer for the TrackWise Investigation/CAPA module.
  

• Prepares and reports quality metrics as necessary to ensure upper management is aware of trends and ongoing activities relevant to investigations, CAPA, etc.
  

• Ensures that documentation is maintained in accordance with internal procedures and regulatory requirements.
  

• Assess accuracy and compliance of procedures as an SOP author, reviewer, and approver and work with cross-functional approval panels for timely, accurate document revisions.
  

• Supports and maintains an environment that fosters communication and teamwork within Quality Assurance and related departments.
  

• Performs the function of Senior QA Specialist and other related assignments and duties as required and assigned.

Requirements:

• Minimum of 5 years’ experience GMP/Biopharmaceutical/Biotech Industry/FDA
  

• 3-5 years specific QA hands-on experience in a pharmaceutical environment, cell and gene therapy experience preferred.
  

• Bachelor’s Degree in a technical or scientific discipline or equivalent
  

• Operational knowledge of cGMP regulations and guidelines including but not limited to U.S. Code of Federal Regulations 21 CFR Part 11 and Part 210 & 211
  

• Demonstrated Project Management abilities to lead and manage several projects, meeting deadlines, and use critical thinking skills to problem solve effectively.
  

• Excellent verbal and written communication skills at all levels of the organization.
  

• Technical writing is required.
  

• Experience with the authoring and execution of Quality documentation including SOPs, CAPAs, and Investigations.
  

• Experience with FDA, and EMA inspection interaction.
  

• Strong experience working in cross-functional teams.
  

• Ability to influence, negotiate, manage conflict, and collaborate.
  

• Must demonstrate a “can-do” attitude.
  

• Proficient in computer skills as a business tool, specific work experience using Microsoft applications (Word, Excel, PowerPoint).
  

• Knowledge of application software such as Trackwise, and SAP, preferred.

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