Scientist I - Compliance
Jubilant Pharma Limited
Summary
The Compliance Scientist I is responsible for the qualification, repair, maintenance and compliance of laboratory instruments and software.
Job description
- Perform preventative maintenance and qualification activities on laboratory instrumentation as directed.
- Implement appropriate computer operating system permissions to laboratory equipment workstations in order to comply with regulatory requirements.
- Diagnose laboratory equipment issues and perform the necessary maintenance to return equipment to a compliant functionality. Assist in other forms of troubleshooting as directed by the Supervisor.
- Prepare acceptance reports for laboratory equipment.
- Complete core training per procedures.
- Adhere to the pertinent aspects of plant safety programs and in keeping with GMP's or other regulations.
- Maintain and operate laboratory equipment to assure accuracy and confidence in performance.
- Perform computer systems backup as required and ensure data integrity is maintained.
- Create new procedures as needed.
- Participate in direct internal and/or external client interactions.
- Perform special assignments as directed by Supervisor.
Working Environment
- Ability to lift 25 pounds unassisted.
- Repetitive Activity.
- Prolonged sitting and standing.
- Potential exposure to allergens
Requirements
- Associates Degree of Science with minimum 2 years related experience for non-science emphasis
- No experience required with Bachelor's Degree in Hard Science
- 0 to 3 years related experience with Associates Degree in Hard Science
- Bachelor's Degree of Science in Chemistry, Biology, or related hard science (preferred)
- Pharmaceutical experience (preferred)
- FDA regulated industry experience (preferred)
- Laboratory experience (preferred)
- Proficiency in troubleshooting instruments and/or mechanical aptitude (preferred)
- Proficiency with Microsoft operating systems and general understanding of software and database configuration (preferred)
- Working knowledge of chemistry, statistics, computer-assisted data processing, and good manufacturing practices (preferred)
Benefits
- Medical, Dental & Vision
- FSA & HSA
- Life & AD&D Insurance
- Short-Term & Long-Term Disability
- Employee Assistance Program
Company overview
Jubilant Pharma Limited is a global integrated pharmaceutical company headquartered in Singapore with operations spanning multiple continents. As a wholly-owned subsidiary of Jubilant Pharmova Limited, the company operates through three core business segments: Specialty Pharmaceuticals, CDMO (Contract Development and Manufacturing Organization), and Generics & APIs. The Specialty Pharmaceuticals division focuses on radiopharmaceuticals with a network of 48 radiopharmacies in the US, along with allergy immunotherapy products where it holds a 25% market share in the US allergenic extract market. The CDMO segment provides contract manufacturing services for sterile injectables and non-sterile products, while the Generics & APIs business manufactures active pharmaceutical ingredients and solid dosage formulations. With approximately 5,200 employees worldwide, Jubilant Pharma operates six manufacturing facilities serving regulated markets including the US, Europe, and other regions across over 75 countries. The company is recognized as a 'Partner of Choice' by leading pharmaceutical companies globally and maintains strong market positions in radiopharmaceuticals, allergy therapy products, and several key generic formulations.