Lead Auditor - External And Internal Audits

Catalent Morrisville , NC 27560

Posted 3 months ago

Job Description:

Position Overview:

Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent's advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here

This employee will report directly to the Quality Assurance Manager. The Catalent official title is Lead Auditor.

Overview

The Quality Assurance department plays a necessary role in the daily operations of the facility. The primary function of the department is to ensure compliance with FDA and other regulatory agency requirements, as well as internal quality systems requirements for the facility. The department is entirely separate from and independent of the personnel engaged in the direction and conduct of the project. This includes project review for accuracy and compliance, systems implementation and maintenance, documentation management, site-wide systems training, internal and external auditing, and raw material and finished-product release.

The Research Triangle Park (RTP) facility is Catalent's Center of Excellence for Analytical Services and is also home to Catalent's Inhalation franchise including product development, clinical and commercial manufacturing for pMDI, DPI and Nasal Sprays

The Role

  • Manages and leads the Internal Audit program; includes preparing documents prior to the audit, creating PRs in Trackwise and managing audit during execution.

  • Coordinates and responds to Audit Letters or Observations.

  • Discuss observations with site leadership and applicable subject matter experts to determine corrective actions and responses and ensure compliance across site.

  • Support Customer Audit and Supplier Quality programs as required including execution and follow-up.

  • Identify potential compliance issues and task corrective measures to prevent them, participating on assigned teams as required.

The Candidate

  • Bachelor's degree in chemistry or closely related physical science from a four-year college/university or equivalent education and job experience

  • 10+ years' experience in an FDA regulated industry and/or training is required

  • Previous experience interacting with Regulatory Agencies

  • Previous experience with Supplier Quality

  • Broad knowledge and understanding of Quality Systems

  • Able to function independently with minimal supervision.

Position Benefits

  • Medical, Dental, Vision and 401K are all offered from day one of employment
  • 19 days of paid time off annually + 7 paid holidays

Leadership Competencies for Performance and Development

  • Leads with Integrity and Respect

  • Delivers Results

  • Demonstrates Business Acumen

  • Fosters Collaboration and Teamwork

  • Champions Change

  • Engages and Inspires

  • Coaches and Develops

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

Catalent. More products. Better treatments. Reliably supplied.

Visit www.catalent.com/careers to explore career opportunities.

Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.


icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
TMF Lead

INC Research Inc

Posted 1 week ago

VIEW JOBS 8/7/2019 12:00:00 AM 2019-11-05T00:00 JOB SUMMARY Provides oversight of all electronic and/or paper Trial Master File (TMF) management activities for assigned projects from award to final transfer. Drives and oversees successful completion of all TMF scoped deliverables including TMF Plan development, TMF set-up, monitoring document submissions/publishing and processing, oversight and coordination of Quality Control (QC) processes, internal and external audit representation, TMF shipments, etc. Involved in monthly project reviews evaluating operational and financial Key Performance Indicators. JOB RESPONSIBLITIES * Attends Trusted Process meetings such as Kick-Off, QuickStart Camps, Jump Start Camps, Quality Finish Camps, etc. as TMF Subject Matter Expert (SME) and successfully communicates and presents TMF status updates and seeks relevant information to drive the execution/delivery of the TMF. * Evaluates and provides recommendations on optimal TMF set-up. Drives the TMF set-up, structure, and completeness reports. * Actively involved in Collaborative Workspace including set-up and training for the internal or external team members, as applicable. * Collaborates with the Project Lead (PL) and Functional Leads (FL) to ensure TMF documentation is submitted/published in a timely manner and with high quality in order to maintain the TMF in an audit-ready state. Develops plans to increase compliance and follows up on non-compliance, if applicable. * Attends internal project team and sponsor teleconferences and face-to-face meetings as TMF SME as applicable to the project. * Designs and/or delivers study specific TMF training in various formats via teleconference, video conference, and/or in person. * Generates and provides Completeness Reports to the Project Team * Prepares and participates in audits/inspections to ensure ongoing readiness of the TMF. * Provides regular feedback to the Project Team on TMF health/status, including actionable metrics. As necessary,provides re-training to the Project Team. * Represents the TMF during Quality Finish Meetings, provides guidance to the Project Team and TMF Operations Team on perfoming the final QC/Completeness Review, and oversees the TMF Shipment. * Ensures thorough understanding of contracted scope, timeline, and budget for the TMF. Works with department management to monitor TMF team performance to the budget and documents any out-of-scope work in Change Notification Form/Change Orders as required. * Presents monthly TMF status, risks, issues and associated actions for assigned projects during the Project Review Meeting (PRM). * Performs other work-related duties as assigned. Minimal travel may be required (up to 25%). QUALIFICATION REQUIREMENTS (please indicate if 'preferred') Undergraduate degree and moderate experience in a Contract Research Organization or related field. Experience with leading/co-leading studies from award into maintenance through close-out on a global scale. Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail. Above average attention to detail, accuracy, and organizational, interpersonal, and team-oriented skills. Ability to perform several tasks simultaneously to meet deadlines. INC Research Inc Morrisville NC

Lead Auditor - External And Internal Audits

Catalent