USA - Quality Associate II in Round Lake, IL at APEX Systems

Date Posted: 2/12/2020

Job Snapshot

  • Employee Type:
  • Job Type:
  • Experience:
    Up to 5 year(s)
  • Date Posted:

Job Description

Job #:  1047493
Conducts reviews of documentation and reports for conformance to procedures, protocols and regulatory requirements. Analyzes numerical or attribute data for trends & variances and generates reports from it.

• Responsible for reviewing pertinent documents, records and reports against Standard Operating Procedures for accuracy and compliance to procedures based on regulatory requirements and internal guidelines, etc.

• Facilitate collection and organization of data from various subject matter experts and incorporate into project plans or other reports.

• Support project manager in preparing information for budgeting process, organization of program tasks and follow-up with task owners.

• Revise or review standard procedures.

• Administer and maintain relevant databases, preparing and issuing reports as defined by the area as well as developing custom reports as needed.

• Assist with internal communications to program stakeholders about project needs and by providing & maintaining program records, extracting data from databases and creating reports, collecting relevant data, etc.

• Strong interpersonal skills and good verbal & written communication skills.

• Must have great attention to detail and be a strong problem solver.

• Must have excellent MS Office: Excel (pivot tables and v-look ups), PowerPoint, and Outlook.

• Must be able to handle multiple projects concurrently.

• Knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices is desirable.
Education and Experience

• Completed Bachelors of Science in engineering/science or a similar technical bachelors degree.

• 3-5 years experience in Quality related role with a medical device / Pharma company or other similarly regulated industry.

• Six sigma quality training (such as ASQ classes) is desirable.
EEO Employer
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 844-463-6178.