QC Scientist II
About The Position
The QC MICRO Investigation writer II will operate in a high-throughput environment, completing investigations on behalf of the QC Micro and EM groups. This person is responsible for leading multiple investigations simultaneously and ensuring on-time completion through dedication, tenacity and relationship building with our partners in QA and the various testing groups. As a strong individual contributor, the QC MICRO Investigation writer II will maintain a steady record closure rate while working on moderate complexity investigations, with some variance in difficulty based on the availability. They will also assist more junior investigators when needed and will participate in QC compliance activities related to audits and continuous improvement.
Requirements
- High School Diploma required.
- Knowledge of GMP regulations
- Knowledge of Good Laboratory Practices (GLP) and Good Documentation Practices (GDP)
- Able to read, write, and communicate in English.
- Able to use standard computer programs such as SmartSheet, PowerBI, MS Excel, Word, and PowerPoint.
- Able to work in an evolving environment and adapt to a variety of internal customer’s needs
- Strong computer, scientific, and organizational skills.
- Strong communication skills including active listening, facilitation, and escalation
- Must be legally authorized to work in the United States now and in the future, without sponsorship.
- Must be able to pass a comprehensive background check, which includes a drug screening.
Nice To Haves
- Bachelor’s degree in science related field is a plus but not required.
- 3 or more years working in a GMP regulated environment or Quality Role (QA or QC) preferred.
- 2 or more years as an investigation, CAPA, and deviation writer preferred.
- TrackWise and TapRooT experience is preferred.
- Able to inspire innovation and team effectiveness.
- Enjoys collaborative efforts both internal and external to the department
Responsibilities
- Stay current with training in Success Factors and Thermo Fisher University
- Occasionally conduct RAPID meetings with QA and QC staff
- Use TrackWise software to author investigations
- Be responsible for compliance-related deliverables including: audit support/observation response, presentations to senior management and site leadership, and generating trend reports to better understand the weaknesses in our organization and make suggestions for improvement
- Support compliance culture initiatives and assist manager and supervisor with implementing these changes.
- Develop the team through creation/delivery of proactive and reactive trainings.
- Assist with the development of tools and resources to improve our investigative process.
- Assist Scientist I investigators when needed
- Average 3-4 deviation/OOS/CAPA record closures per month, based on complexity
- Complete overdue assessments and file record extensions as required
- Author/revise SOPs (limited)
- Assist with formulating continuous improvement strategies and timelines
- Other job duties as assigned
Benefits
- competitive remuneration
- annual incentive plan bonus
- healthcare
- a range of employee benefits
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
