Life Science Job at Enzene Biosciences USA
If you are searching for a Life Science Job in the USA, this is an excellent job opportunity for Life Science graduates looking to build a career in biotechnology and pharmaceutical quality operations. Enzene Biosciences, a rapidly growing biotech organization, is hiring a Quality Operations Specialist I in Pennington, New Jersey. This Life Science Job offers hands-on experience in GMP compliance, regulatory documentation, deviation management, and quality systems within a global CDMO environment. For candidates seeking a Life Science Job in the USA with strong career growth, competitive salary, and exposure to advanced biologics manufacturing, this role at Enzene Biosciences could be the perfect opportunity.
About Enzene Biosciences
Enzene Biosciences is a fast-growing biotechnology company specializing in biologics development and manufacturing. The company operates as a Contract Development and Manufacturing Organization (CDMO), supporting pharmaceutical and biotechnology companies with advanced biosimilar and biologics solutions. With strong operations in India and expansion in the United States, Enzene Biosciences focuses on innovation, quality, and regulatory excellence. The company provides scientists and life science professionals with exciting opportunities to work on cutting-edge biologics and pharmaceutical manufacturing technologies.
Job Details:
- Job Title: Quality Operations Specialist I
- Company: Enzene Biosciences
- Location: Pennington
- Employment Type: Full-Time
- Salary Range: $56,000 – $68,000 annually
Quality Operations Specialist Position Overview
Under the oversight of the Quality Operations Manager, this role provides quality oversight and operational support for US QA functions. Responsibilities include document review, deviation management, change control, audit support, and Quality Management System (QMS) reporting while ensuring compliance with cGMP and FDA regulations. The position collaborates closely with cross-functional teams in both the United States and India.
Key Responsibilities
- Review completed GMP records such as production records, cleaning records, and Quality Control assay records
- Participate in operational Quality Risk and Compliance (QRC) activities
- Support inspection readiness (IR), track and close IR actions across multiple workstreams, and assist with meeting coordination and documentation
- Manage updates to Good Manufacturing Practices (GMP) SME Lists for inspections
- Participate in Deviation and Corrective and Preventive Actions (CAPA) closure and lessons learned with Manufacturing personnel
- Follow up on training requirements for the area of responsibility
- Compile system data for quality metrics reporting
- Provide Quality Operations support including Quality on the Floor activities and real-time deviation initiation
- Track new and revised controlled documents and follow up with curriculum owners regarding training updates
- Participate in quality-related training workshops
- Perform other assigned duties as required
Education
- Bachelor’s degree preferred in Life Science, Science, Regulatory field, or equivalent experience
Experience
- Minimum 1–2 years experience in a GMP industry
- Experience in Pharmaceutical Quality Assurance/Compliance or relevant education with knowledge of cGMP regulations
- Internal and external QA/Regulatory audit experience preferred
- Experience with MasterControl preferred
Skills for Life Science Job
- Knowledge of GMPs, FDA regulations, and documentation procedures
- Understanding of cGMP regulations, quality systems, and regulatory requirements
- Experience with electronic management systems such as QDMS, LMS, EDMS, and E-Doc
- Advanced skills with Microsoft Office and Adobe Acrobat
- Experience in biotech startup environments preferred
Communication
- Ability to work effectively in a multi-cultural and multi-site environment
- Capability to communicate system implementation status to senior leadership
- Ability to explain application of cGMP regulations and documentation systems
- Professional communication in an open office environment
Physical Demands
- Sitting, standing, and walking for extended periods
- Use of hands and fingers for typing and document handling
- Maintaining close vision for computer work
- Occasional stooping, kneeling, or crouching to access files
- Ability to lift more than 50 lbs when required
- Work primarily in an office environment using standard office equipment
Benefits of Life Science Job
- Medical, Dental, and Vision Health Insurance
- Life and AD&D Insurance
- Short-Term and Long-Term Disability Insurance
- 401(k) Retirement Plan
- Paid Time Off
