Quality Assurace Associate -SME - Spark Life Solutions Inc
North Carolina, NC 75074
About the Job
Roles & Responsibilities:
- Serve as the Subject Matter Expert (SME)for microbial investigations related to surfaces, viable/non-viable air, water, bioburden, and endotoxin testing.
- Utilize TrackWise to manage and document investigations and CAPA activities.
- Determine the scope, product impact, root cause, and necessary corrective and/or preventive actions in response to microbial excursions.
- Identify potential root causes of microbial excursions and implement immediate mitigation actions to prevent further occurrences.
- Assemble and lead cross-functional investigation teams, conducting interviews and operational observations to complete thorough investigations.
- Lead process improvement and CAPA projects to ensure timely and effective resolution of issues.
- Prepare and present investigation findings during internal audits and regulatory inspections, ensuring robust documentation and defensibility of actions.
- Develop and maintain investigation reports and related documentation with strong technical writing skills, ensuring clarity, compliance, and accuracy.
- Bachelor's or Master's degree in Microbiology,Biology, or a related scientific field.
- 2+ years of hands-on experience in conducting root cause investigations in the pharmaceutical or medical products industry.
- Minimum 5 years of experience in Quality Operations,Microbiology Laboratory, or Quality Assurance.
- Proficiency with TrackWise or similar quality management systems for managing investigations and CAPA documentation.
- Strong understanding of microbial testing methods and contamination control measures.
- Ability to lead cross-functional teams and drive process improvement initiatives to closure.
- Excellenttechnical writing skills, with the ability to document investigations clearly and accurately for regulatory compliance.
- Proven experience in handling microbial excursions related to air, water, surfaces, bioburden, and endotoxins.
- Familiarity with CAPA processes, risk assessments, and regulatory requirements in pharmaceutical/medical device environments.
- Ability to present and defend microbial investigations during regulatory inspections or audits.
Source : Spark Life Solutions Inc
