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Senior Specialist - LIMS Administration
Chestnut Ridge United States
2 months ago
Years of Experience
Workplace Type
Seniority Type
Industry
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Skills
LIMSproject planningbudget spendingcrystal reportselectronic laboratory notebooks
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Shamia Pawaskar
Description
About our client
Strides creates a work environment characterized by an open, entrepreneurial culture that fosters creativity and innovation. Within the rigor of an exciting and challenging industry, employees have an opportunity to work with partners in some of the world’s leading pharmaceutical companies, the best talent, and associate themselves with an organization that is recognized for path-breaking initiatives and adherence to the highest standards of ethics and integrity.
As multinational company, Strides is committed to a culture of diversity, reflected in a substantial and varied workforce across the globe. Employment decisions at Strides are based solely on merit, qualifications and abilities, ensuring a strict anti-discrimination policy based on gender, race, colour, nationality, sexual preference, marital status, age, disability, religion or employment status.
Strides recognizes the demands of the current work environment and importance of maintain a balance between personal and professional responsibilities and aspirations. To that end, their HR policies are designed to provide flexibility and help employees lead a more fulfilled life. Flexi time options, state of art gyms, a cricket club, runners club and artists groups are just some of the facilities available to all Stridians. The company also operates a "We Care" programme exclusively developed to address the wellness and health needs of employees through sessions conducted by doctors at Strides facilities.
Strides also has generous Rewards and Recognition Policies like the Leadership Incentive Compensation Plan, the Employee Stock Ownership Plan, the Long Service Award and Cash Award, all ensure that employees across all hierarchies within the company feel valued, motivated, and fulfilled by their work.
Job description
Responsibilities:
- Prepares crystal reports.
- Creates or approves static data entries.
- Adds/modifies calculations, workflows, and schemas as necessary.
- Codes LIMS system to customize software platform.
- Integrates and customizes software with laboratory instrumentation
- Responsible for instrument integration.
- Builds Crystal Reports.
- Builds/Configure Electronic Laboratory Notebooks.
- Participate in cross-site implementation of new LIMS features and enhancements
- Coordinates roll-out of additional LIMS phases..
- Assists in Project Planning and Budget Spending.
- Performs periodic audits on the system, collates and presents the results of the audit to senior management.
- Develop training modules and provide user training as necessary.
- Interact with laboratory personnel to ensure necessary developments are present and functioning, as necessary.
- Interface with IT department on global LIMS issues.
- Follows EH&S procedures to ensure a safe work environment.
- Performs other LIMS-related responsibilities as required by management.
Requirements:
- Bachelor’s degree in life science, physical science, or technology field with 5+ years’ laboratory experience performing development functions for a GMP laboratory
- 3+ years’ experience within software development
- Worked within a regulated environment (Pharmaceuticals, Medical Devices, Biotech or other regulated field)
Knowledge:
- Knowledge of 21 CFR Part 11
- Strong knowledge of Computer System Validation techniques and practices
- Company SOPs applicable to job
- Thorough knowledge of general routine laboratory operations and workflow, with the ability to integrate those processes into an electronic workflow
- Strong understanding of Company SOPs applicable to job
- GMP Knowledge of FDA regulations, primarily GMP regulations
- Thorough knowledge of general routine laboratory operations and workflow, with the ability to integrate those processes into an electronic workflow
- In-depth knowledge of Crystal Reports, SQL programming, and SSL scripts or other varying scripting languages such as JavaScript, SQL, Java
Skills & Abilities:
- Advanced computer skills
- Strong attention to detail. Highly productive, able to manage time and prioritize tasks to meet timelines
- Strong interpersonal and communication skills; confident presenter, clear, concise technical writer. Able to interact with various departments and levels
- Customer focused
- Troubleshooting and critical thinking skills. Able to define problems, collect data, establish facts and draw conclusions
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