Catalent Pharma Solutions QA Auditor in Morrisville, North Carolina

Job Description

Job Title

Auditor

Position Summary

The auditor will perform routine auditing of pharmaceutical projects, using established procedures in a GMP environment. This position requires moderate independent judgment with direct supervision in a busy quality department of Catalent’s Analytical Services Site in Morrisville, NC.

The Role (daily responsibilities)

Audit a variety of methodologies as applied to various stages of pharmaceutical development.

Verify accurate transcription of raw data into reports.

Audit above testing for compliance to all applicable SOPs and regulatory requirements.

Discuss issues with lab staff as discovered during final report auditing, laboratory walkthroughs, or other internal audits.

Archive study phase documentation in a timely manner.

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

The Candidate (requirements)

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

1-2 years related experience and/or training is required

The employee must have a good understanding of chemistry/lab practices and be able to function independently with supervision

Good communication and organizational skills are required

Requires knowledge of cGMP, GLP, ICH, and USP regulations or guidelines

Requires contact with multiple departments and on occasion with customers

PLUS: Catalent’s standard leadership competencies that are used to interview and for Performance & Development:

• Leads with Integrity and Respect

• Delivers Results

• Demonstrates Business Acumen

• Fosters Collaboration and Teamwork

• Champions Change

• Engages and Inspires

• Coaches and Develops

About Catalent (STANDARD – DO NOT EDIT!)

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help develop some of the nearly 200 products we launch each year or help supply over 7,000 products for patients around the world. Catalent is an exciting and growing international company where our professionals 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, for the benefit of patients globally.

Catalent. More products. Better treatments. Reliably supplied. ™

Visit www.catalent.com/careers to explore career opportunities, or contact us at

+1 877 503 9493.

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, or protected veteran status. 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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a 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.

Catalent offers rewarding opportunities to further your career – join the global drug development and delivery leader! You will help develop some of the nearly 200 products we launch each year or help supply some of the over 7,000 products for patients around the world. Our highly skilled, dedicated global team of over 9,500 is passionate about improving the health of patients by combining their personal expertise with advanced technologies to advance science and supply innovative new products of the highest quality to patients globally.

Why Catalent?

  • Gain unparalleled experience by working on multiple products and technologies – we launch nearly 200 new products for our customers each year.

  • We have 20 global pharmaceutical Product Development teams on five continents, who are, at any given time, working on over 700 new products and hundreds of ongoing clinical trials.

  • Our products include some of the latest life-saving medicines as well as some of the most well-known consumer health brands used by families every day.

  • Catalent’s more than 30 global facilities on 5 continents manufacture over 70 billion doses of over 7,000 important medicines and consumer health products.

  • Nearly 1 in 20 doses of medicines taken around the world has been touched by the Catalent team.

  • We have +1,100 patents on many superior patient-preferred technologies used by all the top pharmaceutical, biologic and consumer health companies.

  • We established the Catalent Applied Drug Delivery Institute to drive collaboration and scientific exchange among industry professionals, academics and partners.

  • Many of our 1,400+ scientists are regularly published in top industry journals and present at top industry conferences to advance knowledge sharing and the development of better life-saving medicines.

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, or protected veteran status. 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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.