Quality Operations Specialist

About Enzene

Enzene Inc. is an emerging Contract Development and Manufacturing Organization (CDMO) with a strong operational footprint in India. We are a subsidiary of Enzene Biosciences, a leading biotechnology company. Our mission is to provide high-quality biologics manufacturing services to our clients, contributing to the advancement of the pharmaceutical industry.

Under the oversight of the Quality Operations Manager, this position will be responsible for providing quality oversight and operational support for US QA functions, including document review, deviation management, change control, audit support, and QMS reporting. This role will liaise closely with cross-functional teams in both India and the US to ensure compliance with cGMP and FDA regulations.

• Review of completed GMP records (production records, cleaning records, Quality Control assay records, etc)
• Participate in assigned operational Quality Risk and Compliance (QRC) activities
• Support of inspection readiness (IR), tracking and closure of IR actions across multiple parallel work streams, assist with meeting minutes, scheduling of meetings, trainings, process improvement, quality metrics
• Manage updates to Good Manufacturing Practices (GMP) SME Lists for Inspections
• Participate in Deviation, Corrective and Preventive Actions (CAPA) closure and completion of lessons learned in conjunction with Manufacturing personnel.
• Follow-up on training due for area of responsibility
• Compile data from systems for metrics generation as requested
• Other Quality Operations Support to include Quality on the Floor activities and real time deviation initiation.
• Tracking of new and revised controlled documents – follow ups with curricula owners on training changes,
• Participate in quality related training workshops
• Other duties as assigned.

• Education:
  
  Bachelor's degree preferred in Life Science, Science or Regulatory related field and/or equivalent experience
• Experience:
  
  Minimum of 1-2 years within GMP industry; related experience and/or training. Experience in Pharmaceutical Quality Assurance/Compliance or additional education with knowledge of cGMP regulations. Internal and External (QA/Regulatory) Audit experience preferred. Master Control experience preferred.
  
  Skills:
  
  Proficient knowledge of GMP’s, FDA regulations and documentation procedures required, thorough knowledge of cGMP regulations, quality systems and regulatory requirements, Proficiency/knowledge with electronic management systems (such as QDMS, LMS, EDMS, and E-Doc) Advanced skills with MS Office applications and Adobe Acrobat, experience with Biotech startup environments.
• Communication:
  Comfortable and able to operate in a multi-cultural, multi-site environment. Able to communicate system implementation status for senior leadership. Able to explain application of cGMP regulations, quality systems and regulatory requirements for documentation system. Able to work professionally & productively in an open office environment.

• This job includes sitting, standing, walking, using hands/fingers for typing and handling documents, reaching, and maintaining close vision for computer work
• This job operates in an office setting using standard office equipment such as computers, phones, calculators, copiers, fax machines, and file cabinets
• This job may require stooping, kneeling or crouching for accessing files in lower cabinets or performing other tasks
• May need to lift more than 50 lbs
• Must able to sit and stand for long periods of time.

At Enzene, we foster a collaborative and innovative environment where science and business intersect. Our team is dedicated to pushing the boundaries of biosimilar manufacturing, and we are constantly striving to improve processes and patient outcomes. Joining Enzene means being part of a company that values integrity, innovation, and collaboration in pursuit of scientific excellence. We offer an environment of growth, learning, and opportunity in a sector that is driving change in healthcare.

Salary Range: $56k - $68k Annually

• Life and AD&D Insurance
• Disability Insurance (LTD & STD)
• 401k Retirement Plan
• Paid Time Off

Enzene is an equal opportunity employer, committed to fostering a diverse and inclusive work environment where all employees can thrive.