Lonza America Inc

Batch Release Specialist, Quality Assurance Operations

Lonza America Inc • $75K — $95K *
Houston, TX 77084In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
2 weeks ago
Job Overview by Ladders

Qualifications

  • Bachelor's degree in life sciences or related field.
  • 7-10 years of batch disposition experience in a cGMP setting.
  • Direct experience in the pharmaceutical industry with GMP regulations.
  • Skilled in Root Cause Analysis Tools and Risk Management.
  • Proficiency in Microsoft Office, TrackWise, DMS, SAP, and LIMS systems preferred.
  • Commitment to safety, quality, and adherence to timelines.
  • Familiarity with key GMP compliance standards and guidelines.

Responsibilities

  • Oversee batch disposition and maintain tracking systems.
  • Collaborate with teams to complete batch records and reports.
  • Mentor junior staff on record management and feedback processes.
  • Work with Project Management and QA to enhance batch release protocols.
  • Identify and implement Quality Systems improvements.
  • Ensure compliance with quality systems and cGMP standards.
  • Promote job safety and report health and safety incidents.

Benefits

  • Comprehensive health and wellness programs.
  • Opportunities for professional development and training.
  • Flexible work schedule to promote work-life balance.
  • Supportive team environment fostering collaboration and growth.
Full Job Description
Key responsibilities:
  • Disposition of batches manufactured at the LHI site, including maintaining a batch release tracking system.
  • Collaborating with other teams to ensure all necessary tasks for batch disposition are finished, including performed batch records, deviations, change controls, and Environmental Monitoring reports.
  • Mentoring junior staff members in helping to address feedback on batch records and test record forms.
  • Collaborating with the Project Management and QA leadership teams to implement changes to the batch release process, improving compliance, effectiveness, and efficiency.
  • Identifying and implementing improvements in the Quality Systems to boost compliance and efficiency.
  • Maintaining quality systems and cGMP compliance by ensuring team adherence to processes, procedures, and instructions.
  • Promoting and ensuring job safety, attending required health and safety training, and reporting any actual or potential accidents and injuries promptly.


Key requirements:
  • Bachelor's degree in life sciences (biotechnology, biochemistry, biology, chemistry, engineering) or related field.
  • Proven track record (7-10 years) in batch disposition activities within a cGMP environment.
  • Direct GMP experience within the pharmaceutical industry.
  • Proficiency in Root Cause Analysis Tools, Risk Management, Technical Writing, Microsoft Office applications, TrackWise, DMS, SAP, and LIMS systems preferred.
  • Strong contributor who prioritizes safety, quality, and timelines.
  • Knowledge of GMP compliance, including 21CFR210, 211, 820, and the PICS Guide to Good Manufacturing Practices, ICH Q7, 13485, and Part 11 compliance preferred.

About Lonza America Inc

Lonza America Inc is a subsidiary of Lonza Group, a Swiss multinational company that provides products and services to the pharmaceutical, biotech, and specialty ingredients markets. Lonza America Inc is responsible for the North American market and offers a range of products and services, including custom manufacturing, research and development, and quality control testing. The company has a strong focus on sustainability and has implemented various initiatives to reduce its environmental impact. Lonza America Inc was founded in 1897 and has since grown to become a leading provider of products and services in the pharmaceutical and biotech industries.
Learn more about Lonza America Inc
Size
16,218 employees
Industry
Business Services
NASDAQ
LZAGY
* Ladders Estimates

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