Join Enzene Inc., a leading Contract Development and Manufacturing Organization (CDMO), as a Quality Control Lab Compliance Manager in Hopewell, New Jersey. Contribute to our mission of delivering high-quality biologics manufacturing services.
About Enzene Inc.
Enzene Inc., a subsidiary of Enzene Biosciences, is an emerging CDMO with a robust presence in India. We specialize in biologics manufacturing, driving innovation in the biopharmaceutical industry. Our commitment to quality fuels advancements in healthcare.
Position Overview
The Quality Control Lab Compliance Manager ensures laboratory operations adhere to regulatory standards, overseeing stability and sample receipt programs. This role is pivotal in maintaining high-quality outputs in our state-of-the-art facility.
Key Responsibilities
- Quality Control Oversight: Manage lab processes to meet compliance and quality standards. Develop and oversee stability and sample receipt programs.
- Equipment Management: Review equipment logbooks, audit trails, and ensure timely maintenance and calibration.
- Non-Conformity Resolution: Investigate compliance issues, including OOS and deviations. Implement CAPA and initiate change controls.
- Audits and Inspections: Conduct regular audits of lab practices and documentation to ensure regulatory compliance.
- Technology Transfer: Lead protocol/report writing, training, and support method validation with lab managers.
- Training Programs: Maintain training records, identify needs, and develop QMS-based training curricula.
- Team Leadership: Guide and mentor lab compliance officers and technicians.
- Regulatory Compliance: Stay updated on industry regulations to ensure lab adherence.
- Data Analysis: Review lab data for trends, ensure data integrity, and prepare compliance reports for global meetings.
Qualifications
| Requirement | Details |
|---|---|
| Education | Bachelor’s in Chemistry, Biochemistry, Biotechnology, or related field |
| Experience | 5-7 years in analytical method development/validation; 1-3 years in audits |
| Skills | Proficient in HPLC, UPLC, ELISA, LIMS, Veeva, TrackWise; strong analytical skills |
Technical Skills
- Expertise in HPLC, UPLC, Gas Chromatography, Atomic Absorption, and ELISA.
- Knowledge of LIMS, Veeva, TrackWise, and Master Control systems.
- Familiarity with analytical methods like CCIT, Water Testing (TOC), and Karl Fischer.
Physical Demands
- Involves sitting, standing, walking, and using hands for typing/handling documents.
- Requires close vision for computer work and occasional stooping or kneeling.
- Operates in an open office with standard equipment (computers, copiers, etc.).
Why Join Enzene?
At Enzene, you’ll thrive in a collaborative, innovative environment where science meets business. We’re dedicated to advancing biosimilar manufacturing and improving patient outcomes. Enjoy growth opportunities in a dynamic healthcare sector. Explore more at Enzene’s website.
Benefits of Working at Enzene
- Innovative Culture: Work with cutting-edge biologics manufacturing technologies.
- Career Growth: Access training and development to enhance your expertise.
- Impactful Work: Contribute to healthcare advancements through quality biologics.
- Collaborative Team: Join professionals passionate about scientific excellence.
How to Apply
Ready to make a difference? Apply for the QC Lab Compliance Manager role through Enzene’s careers page. Submit your resume and cover letter highlighting your qualifications and passion for quality control.
Application Tips
- Tailor your resume to emphasize relevant lab and compliance experience.
- Highlight proficiency in analytical methods and regulatory standards.
- Prepare for interviews by researching CDMO industry trends via BioPharma Dive.
Verified by Trusted HRs
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Work Environment in Hopewell, NJ
Hopewell, New Jersey, offers a vibrant community with proximity to major cities like Princeton and Philadelphia. Enjoy a blend of professional opportunities and a high quality of life. Learn more at Hopewell Township.
Equal Opportunity Employer
Enzene is committed to diversity and inclusion, fostering an environment where all employees thrive. We are an equal opportunity employer, valuing integrity and collaboration.
Take the Next Step
Join Enzene Inc. and shape the future of biologics manufacturing. Apply today to become our Quality Control Lab Compliance Manager in Hopewell, NJ!
