- Title: QC-LIMS Specialist
- Code: RCI-8942
- Location: Summit New Jersey (NJ) 07901
- Posted Date: 01/13/2020
- Duration: 9 Months
- Name:Mittal Mandavia
- Email: email@example.com
- Phone: 908-704-8843 ✖ 245
PURPOSE AND SCOPE OF POSITION:
This position is responsible for the harmonization, life-cycle management and continuous improvement of all GMP quality system elements within the Laboratory Systems technology platform including but not limited to LabWare. In this role, the incumbent will serve as the primary business representative for governance related activities and cross-functional partnerships and collaborations. This role will manage staff as required. This is a highly visible role with global responsibility and cross functional influence that has a high degree of impact on departmental performance, broad quality initiatives, Quality Control, Quality Operations and the Business.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
- Must have expert GMP, Quality, and in-depth risk management knowledge.
- Must be able to effectively prepare communications with interpretation of data analysis and potential problems to management and the group with clarity and a high level of accuracy.
- Must be able to note technical/scientific attributes in potential situations or issues and process science-based solutions across a majority of the job function.
- Must provide guidance to other employees in the interpretation of technical/scientific issues across a majority of the job function and manage development of technical or scientific initiatives and activities by interdisciplinary teams.
- Must develop employees and coach them to bridge knowledge gap.
- Most have strong authorship and be able to critically review reports while effectively inputting and expressing Quality risk management principles.
- Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking. Must possess an independent mindset and tenacity.
DUTIES AND RESPONSIBILITIES
- Management of Master Data. Examples include: – create/ modify tests, products, sample groups templates, specifications, methods, materials, etc.
- Special permissions to support site business users (edit of locked data, moving data to non-routine phases, folder creation, etc.)
- Single point of contact between sites & global business units & IT
- Lead trainer for respective area
- Has risk and issue ownership
- Work with site admins on complex issues as required Stability-specific specialty expected to support:
- Stability data management: create/modify stability protocol, stability specification, intervals, conditions, locations, etc. ELN-specific specialty expected to support:
- Site-specific ELN templates and master data (yet to be defined) Quality Control experience desired.
EDUCATION AND EXPERIENCE
Relevant college or university degree preferred. Equivalent combination of education and experience acceptable.
Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated, but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.