Quality System Specialist

3 weeks ago

Middleton, United States CareerBuilder Full time

Job Description

The Quality System Specialist will play a key role on the companys Quality Assurance team, driving and administering quality system activities in multiple areas of focus. This position will ensure effective management of key operational duties specific to quality training, change management and document control, record review and retention, customer feedback and complaint management, and monitoring and measurement of quality and business objectives. The Quality System Specialist will have responsibility for supporting the documentation, effective maintenance, and improvement of the sites Quality Management System to maintain regulatory compliance and ISO certifications.

Conduct batch history records (BHR) reviews that include but are not limited to; completeness, accuracy, the use of good documentation practices, etc. prior to approval and product release.

May support the Complaint Change Review Board through assisting in complaint investigations and developing corrective actions to address complaints.

Promote a collaborative approach with team members, functional departments, and other LGC sites.

Monitor and report on designated quality/business metrics and creation of new quality/business metrics; assist with reporting to top management on the performance and integrity of the QMS and needs for improvement, promote awareness of quality and customer requirements throughout the organization.

Partner with Operations in developing effective Quality documents (Batch History Records and related technical SOPs), ensuring adherence to product labelling requirements.

Coordinate with QA team members on the maintenance, execution and improvement of related QMS processes: nonconformances, corrective and preventive action, process/product deviations, training management and complaint management.

Support development, maintenance, improvement and implementation of customer facing documentation (Certificates of Analysis, User Manuals, Application Notes, Customer Quality Questionnaires) as necessary.

Qualifications:
Qualifications

_

Qualifications: _

Bachelor Degree in STEM field is preferred, Associates Degree is required.

2 years work experience in a quality role is preferred. Educational experience in a lab will be considered.

Certificate in or secondary studies in Quality is preferred.

Familiarity with international Quality System requirements, particularly ISO 13485, FDA, or GMP is preferred.

Experience in a document and records control or technical writing/procedural writing role.

Working knowledge of Electronic Quality Management Software (eQMS).

Basic knowledge of descriptive statistics and its application to sampling plans, specification setting, and process control.

Additional Information

What we offer (US based-employees):

Competitive compensation with strong bonus program

Comprehensive medical, dental, and vision benefits for employees and dependents

FSA/HSA Pre-tax savings plans for health care, childcare, and elder care

Deductible Buffer Insurance and Critical Illness Insurance

401(k) retirement plan with matching employer contribution

Company-paid short- and long- term disability, life insurance, and employee assistance program

Flexible work options

Pet Insurance for our furry friends

Enhanced Parental leave of 8 additional weeks

PTO that begins immediately

Town Hall monthly meeting onsite/virtual, Cheer program where employees are recognized for outstanding work, Company wide social events, frequent catered lunches and much more

Qualifications

_ **Qualifications:**_

* Bachelor Degree in STEM field is preferred, Associates Degree is required.
* 2 years work experience in a quality role is preferred. Educational experience in a lab will be considered.
* Certificate in or secondary studies in Quality is preferred.
* Familiarity with international Quality System requirements, particularly ISO 13485, FDA, or GMP is preferred.
* Experience in a document and records control or technical writing/procedural writing role.
* Working knowledge of Electronic Quality Management Software (eQMS).
* Basic knowledge of descriptive statistics and its application to sampling plans, specification setting, and process control.

Additional Information

**What we offer (US based-employees):**

* Competitive compensation with strong bonus program
* Comprehensive medical, dental, and vision benefits for employees and dependents
* FSA/HSA Pre-tax savings plans for health care, childcare, and elder care
* Deductible Buffer Insurance and Critical Illness Insurance
* 401(k) retirement plan with matching employer contribution
* Company-paid short- and long- term disability, life insurance, and employee assistance program
* Flexible work options
* Pet Insurance for our furry friends
* Enhanced Parental leave of 8 additional weeks
* PTO that begins immediately
* Town Hall monthly meeting onsite/virtual, Cheer program where employees are recognized for outstanding work, Company wide social events, frequent catered lunches and much more

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