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Job Details

Supplier Quality Auditor

Company name
Lonza Biologics Inc

Location
Walkersville, MD

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Job Description:

Lonza welcomes all Capsugel employees.

At Lonza, we invest in great people. We encourage our employees to challenge themselves and we offer an environment that fosters creativity and success.

Headquartered in Basel, Switzerland, we operate production, R&D, and business sites around the world, including Europe, North America, and Asia. 

Our vision

We strive to be the leading supplier using science and technology to improve the quality of life.

Our mission

We work with passion, using advanced technologies, to transform life science into new possibilities for our customers.

Do you want to help us as we shape the future of this great organization?

Job Description Summary

Ensure the uninterrupted supply of materials and services to Lonza by assessing the quality of the Suppliers and their ability to meet defined requirements utilizing tools such as Quality Risk Management (QRM), supplier assessment/audit, change management, and complaint/deviation trend management.

Key Accountabilities and Duties:

Perform Supplier Quality assessments/ audits of Suppliers to annual plan and follow up on agreed upon CAPAs.

Assure issues are timely classified, communicated to the supplier and to Lonza Sites.

Promptly notify and escalate to Regional Head Supplier Quality any potential quality or regulatory issues that may affect product quality or regulatory compliance.

Participate in the reporting of QA Supplier performance - this is to include Risk Assessment ranking and managing of defined KPI’s.

Participate in projects as defined and ensure that all aspects are implemented and followed up.

Support regional team to find solutions for supplier production, quality and negotiation problems.

Support Lonza QMS and SOPs for Global Supplier Quality as assigned.

Perform other duties as assigned. 

Minimum Required Qualifications/Skills:

Bachelors degree in the Life Sciences, preferred.

Intermediate experience in a regulated industry preferably pharmaceutical or biopharmaceutical. with a focus in auditing (internal / external) manufacturing facilities, equipment, laboratories and service providers.

Certified Quality Auditor (ASQ or equivalent).

Sound knowledge of cGMPs, ISO standards and international regulations.

Knowledge of manufacturing processes and OE tools (i.e. statistical methods, FMEA, Six Sigma, Lean).

Ability to interpret and relate Quality standards to make sound quality decisions. A working knowledge of the current regulations and the ability to apply that knowledge to assure that providers of materials and services are compliant.

Travel up to 50%

Good interpersonal, negotiation and communication skills in English.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

Lonza.  The place to Go, Stay and Grow.

Company info

Lonza Biologics Inc

Company Profile

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