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Quality Engineer

Apex Systems La Vergne Contractor
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The Quality Engineer will review Test data and use the information to drive continuous improvement at the facility, ensure that it is meeting all Internal and External requirements, verify that the information is available to review in audits, management review, and information that is needed to support CAPA/Risk Assessment activities. 

Responsibilities:

  • Responsible for management of assigned customer complaints, CAPAs, deviations/nonconformances.
  • Responsible for daily batch release process.
  • Perform Equipment Qualification, Inspection and Test Method Validations
  • Assists in leading and/or participating in supplier and customer audits.
  • Demonstrated planning and project management skills.
  • Solid presentation skills that include summarizing and communicating with customers, suppliers, and management.
  • Lead investigations surrounding manufacturing packaging non-conformances; environmental differential pressure, temperature and/or humidity; stability and microbiological excursions with effective corrective and preventive actions.
  • Write and revise SOP’s, test methods, cleaning studies and other quality documents.
  • Evaluate and interpret analytical data associated with product release, stability reports, manufacturing investigations to ensure cGMP compliance prior to final product release.
  • Responsible for accuracy and integrity of documentation generated, as well as compliance with cGMP's and Quality Control guidelines issued by FDA and other applicable agencies.
  • Other duties as assigned. 

Qualifications:

  • Bachelor of Science Degree in Technical major such as Biomedical Engineering
  • 3+  years Device and/or Pharmaceutical QA/QC/Validation experience
  • Familiarity with FDA regulations a must
  • Experience working within a current Good Manufacturing Process environment
  • Expertise in cGMP’s and quality systems as related to Rx prescription and Over the counter drug products.
  • Knowledge in compendial (AAMI, USP, ISO) methodologies and techniques.
  • Team building skills: the ability to work cross functionally in a cooperative manner with a diverse workforce
  • Ability to multi-task with great attention to detail
  • Skilled in planning, organizing, coordinating projects and working independently.
  • Ability to write procedures and work instructions
  • Ability to read and interpret documents related to medical device or pharmaceutical packaging including International standards, regulations, technical procedures, journals, regulatory publications, etc.
  • Working knowledge of MS Word, Excel, PowerPoint, MS Outlook, Visio, and Project 

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

 

Recommended skills

Product Quality Assurance
Self Motivation
Packaging And Labeling
Risk Analysis
Team Building
Validations
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WHAT WE DO:

Apex Systems is a division of the 2nd largest IT staffing and services firm in North America. From consulting to staff augmentation, we connect top tech talent with great companies in all industries.

OUR CREDENTIALS: 

Apex earned Inavero’s Best of Staffing™ Client Diamond and Talent Awards for providing superior service to clients and job seekers, putting the company in the top 2 percent of all U.S. staffing agencies.

SUPPORTING OUR CONTRACT EMPLOYEES:

We take the time to understand a candidate’s talents and needs to ensure a good match with companies for contract, contract-to-hire, and direct hire positions. Each recruiter within Apex is focused on a specific skill area within infrastructure, applications, and project management. This focused discipline enables our local recruiters to work directly with our candidate’s and focus their talent on the right position at the right time.

WHO OUR CUSTOMERS ARE: 

We serve Fortune 500, mid-market, and emerging companies from a wide variety of industries, including communications, energy, financial services, government services, healthcare, technology, and utilities. 

WHERE WE ARE: 

Apex has branches in over 70 locations across the U.S. and Canada and more than 1,000 employees dedicated to supporting the needs of our clients and contract team members. Visit www.apexsystems.com to find a local branch or connect with an Account Manager or Recruiter.

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