Epicareer Might not Working Properly
Learn More
Please Turn on your JavaScript

Epicareer might not working properly because your browser javascript is turned off.

What is JavaScript?

JavaScript is like the magic behind making websites interactive. Basically, it makes Epicareer more enjoyable and engaging.
How do i turn this on?
Find tutorial for your browser below :
  1. Make sure the webpage is open.
  2. In the Safari app on your Mac, choose Safari > Preferences, then click Security.
  3. Make sure the Enable JavaScript checkbox is selected.
  4. Click Websites.
  5. On the left, click Content Blockers.
  6. Make sure Off is chosen in the pop-up menu next to the website.
  7. On the left, click Pop-up Windows.
  8. Make sure Allow is chosen in the pop-up menu next to the website.
Visit Site here
  1. Open Chrome on your computer.
  2. Click. then Settings.
  3. Click Privacy and Security.
  4. Click Site settings.
  5. Click JavaScript.
  6. Select Sites can use Javascript.
Visit Site here
  1. If you're running Windows OS, in the Firefox window, click Tools > Options.
  2. Tip: If you're running Mac OS, click the Firefox drop-down list > Preferences.
  3. On the Content tab, click the Enable JavaScript check box.
Visit Site here
  1. Click the "Settings and more" icon at the top right of the Edge browser window.
  2. Click Settings.
  3. From the Settings menu, click Cookies and site permissions.
  4. Scroll down and click on JavaScript.
  5. In the JavaScript window, toggle the slider to "on" or "allowed."
  6. Close the Settings tab.
  7. Refresh the page.
Visit Site here
  1. Go to Settings.
  2. Click Advanced in the left sidebar, and click Privacy & security.
  3. Under Privacy and security, click Site settings.
  4. Click JavaScript.
  5. At the top, turn on or off Allowed (recommended).
Visit Site here
Any Question? Contact us
logo
Jobs or company...

Specialist Quality Assurance

  • Full Time, onsite
  • BioPharma Consulting JAD Group
  • On Site, United States of America
Salary undisclosed

Apply on

Dice
Original
Simplified

Job Description

Job Description

Summary:

The Specialist Quality Assurance will play a key role in supporting Quality Assurance program by performing quality oversight, risk assessments, and compliance activities for manufacturing processes. This position ensures adherence to regulatory standards and internal procedures, collaborating across departments to drive process improvements, manage compliance, and serve as a representative for QA on cross-functional teams.

Key Responsibilities:

  • Review and approve manufacturing processes (MPs) and validation protocols/reports.
  • Represent Quality Assurance on incident triage and New Product Introduction (NPI) teams.
  • Lead site audits, investigations, and environmental characterization assessments.
  • Oversee the release of sanitary utility systems and approve planned incidents and risk assessments.
  • Serve as a QA designee on the local Change Control Review Board (CCRB).
  • Approve non-conformance (NC) investigations, Corrective and Preventive Actions (CAPA) records, and change controls.
  • Authorize lot disposition for shipment and oversee lot approvals.
  • Support automation, facilities, and environmental programs as required.
  • Review and approve work orders, EMS/BMS alarms, and quality program procedures.

Experience:

  • Expertise in quality systems such as Deviations, CAPA, and Change Control.
  • Hands-on experience with electronic documentation systems, including CDOCS, Maximo, Trackwise, LIMS, MES, and SAP.
  • Demonstrated experience in GxP application validation, validation master planning, IQ, OQ, PQ protocols, risk assessment, and summary reports.
  • Proven track record as a Quality Contact for projects involving new drug products and extensive experience with equipment and utility qualifications.

Key Skills:

  • Leadership and project management in quality-related initiatives.
  • Strong organizational abilities, attention to detail, and follow-through.
  • Ability to interact with all levels within the organization and work independently.
  • Advanced analytical skills for evaluating compliance issues and identifying process improvements.

Requirements

Education:

  • Doctorate in Science/Engineering, OR
  • Master s degree in Science/Engineering with 3+ years of related experience, OR
  • Bachelor s degree in Science/Engineering with 5+ years of related experience, OR
  • Associate s degree with 10+ years of related experience, OR
  • High school diploma / GED with 12+ years of related experience.

Preferred Qualifications:

  • Strong communication and presentation skills in both English and Spanish.
  • Advanced skills in project management, data trending, and independent problem-solving.
  • Enhanced ability to lead cross-functional teams, influence others, and negotiate effectively.
  • Experience collaborating with regulatory agencies and addressing compliance issues.
  • Proficient with word processing, presentation, database, and spreadsheet software.

Shift Details:

  • 5 days, 8 hours per day.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
Report this job
Similar Jobs