Powdersize - Quality Specialist (II)
United States, Quakertown (Pennsylvania)
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
The Quality Specialist (II) is critical to the Company’s success in providing a quality service to our customers by assisting in the assurance of compliance with organizational Quality Systems and current cGMPs. This role is one of a developing professional who assists and supports the organization with initial compliance and ongoing preparation, testing and monitoring of conformance to established quality assurance processes and standards for manufacturing. This position reports to the QA Assistant Manager and participates in cross-functional duties within the Quality Department including but not limited to the creation and review of batch records, creation of forms and procedures, inspection and release of product, generation of reports/studies and support of quality activities.
- Performs document reviews of SOP’s, batch records, test methods, and logbooks to ensure cGMP activities are completed and documented in accordance with approved, written procedures.
- May also review raw materials, work orders and validation reports.
- Approves SOPs and Master Batch Records.
- Assesses potential impact to product quality for open deviations during lot release.
- Participates in internal audits, vendor audits and customer audits
- Provides support during regulatory audits and inspections. May support internal or external audits.
- May write internal audit reports and vendor audit reports.
- Batch Record Creation.
- Write/Assist with quality related investigations.
- Creation and updating of procedures and forms.
- Maintain accurate records and documentation.
- Inspection and release of labels, consumables, product and equipment after cleaning .
- Assist in the generation of reports from studies conducted within quality departments.
- Perform other business critical duties when necessary as determined by management
- Associate’s Degree in Science required; Bachelor’s Degree preferred
- Quality Control or Quality Assurance experience
- Computer Software skills, record keeping, detail orientated and thorough. Experience with Trackwise and Documentum a plus. Routinely report on quality metrics.
- Basic understanding of cGMP regulations and general knowledge of manufacturing processes
- Shows initiative and is skilled in prioritizing workload in a busy manufacturing environment
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
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.