Compliance Production Associate II
2 months ago
We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, as well as digital and AI solutions for diagnostic and interventional imaging. As a pioneer in contrast products for the last 95 years, we continuously innovate.
WHAT WE'RE LOOKING FOR:
The Technical Writer is primarily responsible for conducting independent investigations, root cause determination and development of appropriate corrective/preventive actions for exceptions/OOSs occurring during manufacturing production at Guerbet. In addition, the incumbent will provide technical expertise to ensure that production activities are accomplished in a high quality, highly efficient and safe working manner. The incumbent serves as a subject matter expert in providing solutions to day-to-day production problems and will troubleshoot process related problems, write and revise SOPs and batch records, evaluate and provide input to internal and external audits. Incumbent is also required to maintain quality-minded, safe and ethical conduct while meeting production standards and schedules. This position is located in Raleigh, NC on first shift.
YOUR ROLE:
Write and finalize both simplified and standard CAPAs.
Leads and manages exception/OOS investigation in manufacturing areas. Utilize investigation tools such as risk assessment, 6Ms and KT analysis to identify investigation scope, true cause and product impact.
Coordinate procedure changes with the subject matter experts in the respective areas.
Work with the various departments in resolving current and potential compliance concerns.
Write and/or review Standard Operating Procedures to ensure they comply with current Good Manufacturing Practices.
Ensure safe work habits are employed and maintain a safe work environment.
Develop reports utilizing statistical tools identifying and trending KPIs.
Provide support and assist Operational Excellence Teams.
YOUR BACKGROUND
Education required/ preferred:
Master’s degree in a Scientific, Engineering or Biotech field with 2-5 years’ experience in biopharmaceutical manufacturing processing in a GMP compliant environment
BA/BS Science, Biotech or Engineering Degree with 3-6 years’ experience in biopharmaceutical manufacturing processing in a GMP compliant environment.
Associate’s Degree/HS Diploma with 6-10 years’ experience in biopharmaceutical manufacturing processing in a GMP compliant environment.
Experience:
Conducting, writing and remediating investigations
Authoring and/or revising technical documents
Working cross-functionally, lead teams
Preferred Skills/Qualifications:
Knowledge of investigational tools such as risk assessment, 6Ms analysis.
Exposure to conflict resolution and decision making.
Experience in root cause analysis.
Skills/Competencies:
PC proficient to include MS Office Suite.
Other Skills:
Good organizational skills and ability to coordinate multiple projects.
Must be able to work effectively in a team-based environment.
Skills/Competencies:
PC proficient to include MS Office Suite. Expertise in statistical programs and Access databases preferred.
Other Skills:
Good organizational skills and ability to coordinate multiple projects. Must be able to work effectively in a team-based environment.
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