Job Description Job #: 1025247
Under minimum supervision of the supervision of the Director, Quality Assurance & Regulatory Compliance (QA/RC), the Quality Control Technician II is responsible for ensuring compliance and continuous improvements for business processes relating to the Quality Management System. Primary responsibilities include: site compliance to applicable Standards and Regulations; validations; supplier coordination; control of measuring device; and diverse QA/RC administrative tasks.
Duties and Responsibilities
- Work in compliance with North America Distribution Center Quality Management System and Quality Policy Requirements.
- Support the environmental validations coordinator as needed.
- Responsible for documenting validation protocols
- Responsible for executing validations as required
- Responsible to document validation reports
- Observe good documentation practices
- Coordinate with vendors to support preventive maintenances, calibrations and other needs as required to support validations
- Coordinate with other sites to facilitate validations
- Build custom equipment needed to support validations
- Support the installation of temperature monitoring equipment
Minimum Skills, Competencies and Qualifications
- Knowledge of Medical Device regulations and associated standards, e.g. QSRs, ISO 9001, ISO 13485.
- Must have strong organizational, interpersonal, written and verbal communication skills.
- Must be self-directed, adept at juggling multiple projects and comfortable in a fast-paced and ever-changing work environment.
- Demonstrated ability to carry out assignments in a timely, accurate manner, following directions and accomplishing tasks as required.
- Excellent organizational skills.
- Must have hands-on experience with Microsoft Office Suite (e.g. Excel, Word, PowerPoint, etc.) and Enterprise Resource Planning (ERP) Systems, SAP preferred.
- Data reporting and analysis.
- Professional demeanor
Education & Experience
- High School/ GED graduate or equivalent.
- BS in a science-related field is preferred
- Three to five years relative work experience
- Experience in the validation field
- Experience in environmental validation is a plus
- Experience with IVD products is a plus.
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [ Phone number blocked ] -6178.