Compliance Scientist I, II, III
Jubilant Pharma Limited
Summary
The Compliance Scientist I, II, III is responsible for the qualification, repair, maintenance and compliance of laboratory instruments and software.
Job description
Responsibilities for All Levels (I, II, III)
- 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.
Additional Responsibility for Level II
- Coordinate and lead group projects related to laboratory compliance and equipment qualifications.
Additional Responsibilities for Level III
- Assist in training other analysts.
- Lead and coordinate implementation of improvements to laboratory compliance and equipment maintenance and qualification processes.
- Stay informed of changes to compendial requirements for laboratory equipment and implement within the required timeframe.
- Perform compliance related audits for laboratory equipment and associated workstations to ensure an appropriate level of compliance is maintained.
- Demonstrate leadership and subject matter expertise within the department and outside the department as needed.
Working Environment
- Ability to lift 25 pounds unassisted.
- Repetitive activity.
- Prolonged sitting and standing.
- Potential exposure to allergens.
Requirements
- Compliance Scientist I: No experience required with a Bachelor of Science degree in a related scientific discipline
- Compliance Scientist I: Minimum of two (2) years of related experience with an Associate or Bachelor of Arts degree
- Compliance Scientist II: Minimum of two (2) years of laboratory experience with a Bachelor of Science degree
- Compliance Scientist II: Minimum of three (3) years of laboratory experience with an Associate or Bachelor of Arts degree
- Compliance Scientist III: Minimum of three (3) years of laboratory experience with a Bachelor of Science degree
- Compliance Scientist III: Minimum of five (5) years of laboratory experience with an Associate or Bachelor of Arts degree
- 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 understanding of software and database configuration
- Preferred: Working knowledge of chemistry, statistics, computer-assisted data processing, and good manufacturing practices
- Preferred for Level II: Experience with computer-related systems, databases, and/or servers
- Preferred for Level III: 3 years of pharmaceutical experience strongly desired
- Preferred for Level III: Ability to utilize scientific literature and make effective written and oral reports
- Preferred for Level III: Self-motivated with good communication and human relation skills
- Preferred for Level III: Ability to work in a team setting supporting project teams as a Quality Unit representative
Benefits
- Medical, Dental & Vision
- FSA & HSA
- Life & AD&D Insurance
- Short-Term & Long-Term Disability
- Employee Assistance Program
- Benefits start day one
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.