Specialist, Quality Assurance (Master Batch Record)

Responsibilities

• Provide oversight to day-to-day Quality Assurance activities in accordance with approved
• SOPs / Plan / Policies for a large scale, multi-product, GMP biotech contract manufacturing facility.
• Mastery and knowledge of processes is recognized by colleagues as a source of expertise.
• Strategic in Quality Systems or Quality Operations planning.
• Work within the Lonza Global network and establish themself as an industry expert within both Lonza and outside.
• Able to direct appropriate follow-up actions on any compliance issues.
• Participates in policy making.
• Ability to communicate quality operations and compliance perspective effectively to senior management.
• Own and lead special projects, often complex in nature.
• Understands and articulates company business strategy. Maintains a broad view of the business recognizes changes and trends in the appropriate area in which the individual operates.
• Look to assign projects to staff for cost-savings.
• Provide direction to staff and/or lead projects in global harmonization/ efficiency.
• Education Experience
• Engineering/Science Diploma/Degree or higher from recognized institution
• 1-4 years working experience within the pharmaceutical manufacturing industry
• Excellent knowledge and adherence to all relevant codes, standards and regulatory requirements
• Ready to shape the future of life sciences?

Additional Information

The Quality Assurance Department is looking for Specialist, QA to join the team. You will be supporting day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, cGxP contract manufacturing facility. Display a good level of problem-solving ability by analyzing and interpreting data and puts forward new ideas based on scientific knowledge or field experience. Detect non-compliance with cGxP and cGDP requirements and provide guidance on GDP corrections. What you will get: An agile career with opportunities to grow your validation and engineering expertise. An inclusive, ethical, and safety-first workplace. A dynamic site environment supporting advanced biotech manufacturing. Collaboration with experienced engineering, quality, and operations teams. Compensation programs that recognize performance and contribution. Fully paid medical insurance, with options to enroll family members at subsidized rates.

Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at Lonza? Share your experience