Quality Associate Ii, Life Sciences

Azenta Germany GmbH

**At Azenta, new ideas, new technologies and new ways of thinking are driving our future. Our customer focused culture encourages employees to embrace innovation and challenge the status quo with novel thinking and collaborative work relationships.**

**All we accomplish is grounded in our core values of Customer Focus, Achievement, Accountability, Teamwork, Employee Value and Integrity**:
**Job Title**:Quality Associate II, Life Sciences (M/F/x)

At Azenta, new ideas, new technologies and new ways of thinking are driving our future. Our customer-focused culture encourages employees to embrace innovation and challenge the status quo with novel thinking and collaborative work relationships.

Azenta Life Sciences is a global leader in the life sciences space with headquarters in Burlington, MA, and offices and operations worldwide. We are a market leader in automated bio sample management solutions and genomic services across areas such as drug development, clinical and advanced cell therapies for the industry's top pharmaceutical, biotech, academic and healthcare institutions globally. We provide unparalleled capabilities with our lab analysis, sample management and storage services, informatics software, and consumables, with the largest installed base managing over 1 billion samples globally.

**How You’ll Add Value**

As EU Quality Associate you will maintain and implement policies and procedures which result in attaining quality goals and GxP requirements. You will provide direction to all personnel regarding BioBank compliance to all GxP guidelines. All members of the Quality department will be responsible for assuring compliance to established QMS standards and for continuous improvement of the QMS system.

**What You’ll Do**
- Manage and maintain companywide employee training records, including coordination, auditing, and delivery of training.
- Review policies, procedures, and validation documents (e.g. freezer mapping, alarm systems) to ensure best practices and compliance.
- Work within the electronic document management system (e.g. review Change Controls, create accounts).
- Scan, archive, and organize quality documentation (internal and external).
- Handle general administrative tasks: maintain records, manage correspondence, and answer calls.
- Coordinate and support client audits, visits, and respond to quality questionnaires.
- Assist in drafting documents, internal/external audits, and quality-related employee training.
- Ensure compliance with GLP, GMP, GDP, and internal quality standards.
- Support the implementation of the quality system in global branches and ensure consistent communication and escalation of quality-related issues across the organization.
- Contribute to process improvements by proposing practical solutions that support long-term success and compliance.
- Maintain confidentiality and adhere to communication guidelines regarding business and patient information.
- Collaborate effectively with cross-functional teams to achieve shared goals and maintain a positive, respectful work environment.
- Perform additional duties as directed by the EU Quality Manager.

**What you will Bring**
- Degree in Life Science/Engineering.
- Strong analytical skills and the ability to think creatively.
- Strong communication and interpersonal skills.
- Ability to work with different departments
- Competency with Microsoft Office products including Outlook, Word and PowerPoint.
- Preferred _
- Initial Azenta Life Sciences experience.
- Active participant in continuous improvement initiatives.
- Experience writing and managing SOP´s and Quality Assurance and Business Policies.
- Experience with FDA regulations, EMA regulation, ISO 9001 regulations and/or customer audits

**About yourself**
- Demonstrated ability to prioritize work, customers, internal and external demands.
- Strong organizational skill and attention to details.
- Able to act efficiently in an environment with dynamic timelines and priorities.
- Strong interpersonal and communication skills that will build strong internal and external relationships to ensure deliverables are on time and within budget.

**Our offer**
- Trustful cooperation in an innovative company.
- Become part of a company that makes a positive contribution to pioneering scientific developments and therapies.
- Positive corporate culture and active teamwork across all locations.
- Individual development opportunities for your international skills and language skills.
- Attractive working location in the north of Leipzig.
- In order to guarantee our employees a good work-life balance, we offer 30 days' vacation.
- We have a partnership with pme Familienservice to support our employees in all life situations.
- Our other benefits include _
- Profit sharing.
- 5 days special leave for sick children.
- Life insurance.
- Share program.
- Contribution to company pension scheme.
- Company travel health insurance.
- Corporate Benefits Program (onli