AR&D Associate Data Auditor

Winchester, KY - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

AR&D Associate Data Auditor

Catalent Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop manufacture and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma biotech and consumer health customers supporting product development launch and full life-cycle supply. With time-tested experience in development sciences delivery technologies and multi-modality manufacturing Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

The AR&D Associate Auditor is a professional career position within the Analytical Research and Development Department. This position supports data review of Protocol testing release testing and stability testing of all materials from AR&D lab. Employees at this level should manage their time effectively and expected to work with minimal direction while executing a broad range of high visibility tasks to provide scheduling and alignment for the AR&D Department in support of internal and external customers. This position requires strong knowledge of technical and analytical skills to approve data for the AR&D laboratory in timely fashion.

This role is responsible for cGMP and technical review of product development Protocol testing in process/finished good data for release stability testing drafting/reviewing report of analysis and certificate of addition the responsibilities include supporting lab investigations customer/agency audits and performing analytical testing as needed.

This is a full-time on-site position: Monday-Friday 8:00am to 5:00pm

Catalent is committed to a Patient First culture through excellence in quality andcompliance and to the safety of every patient consumer and Catalent employee.

The Role

Support product development protocol testing in-process finished product release and stability by reviewing GMP documents (data notebooks certificate of analysis validation/qualification reports etc.) for compliance with internal SOPs and approved test methods as well as technical accuracy
Read and understand test methods from multiple compendia (i.e. USP/NF EP JP) internal Catalent methods or customer/supplier methods
Participate in customer/agency audits as necessary
Perform analytical testing as needed (minimal)
Assist in laboratory investigations data review
Assist in AR&D stability data and stability summary reports review
Create AR&D report analysis (RoAs) and Certificate of Analysis (CoAs)
Draft or review standard operating procedures as needed; Draft or review CAPAs and audit responses as needed
All other duties as assigned

The Candidate

Must have Bachelors Degree in Chemistry Pharmaceutical Sciences or Life Sciences (Preferred in Analytical Chemistry) and 3 years of Pharmaceutical Industry related experience as a testing analyst/data auditor in cGMP facility or equivalent OR
Masters degree in Chemistry Pharmaceutical Sciences or Life Sciences (Preferred in Analytical Chemistry) and 1 years of Pharmaceutical Industry related experience as a testing analyst/data auditor in cGMP facility or equivalent
Prior experience in a Quality Laboratory Clinical or Chemical manufacturing role auditing testing data and results is preferred
Must have general computer literacy including use of Microsoft Word and Excel
Proficiency in English verbal and written communication skills to convey and receive ideas and instructions to/from others and communicate effectively is required
Individuals may be required to sit and stand for an extended period of time

Why you should join Catalent:

Defined career path and annual performance review and feedback process
Diverse inclusive culture
Positive working environment focusing on continually improving processes to remain innovative
Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
152 hours of PTO 8 paid holidays
Several Employee Resource Groups focusing on D&I
Dynamic fast-paced work environment
Community engagement and green initiatives
Generous 401K match
Medical dental and vision benefits
Tuition Reimbursement- Let us help you finish your degree or start a new degree!
WellHub- program to promote overall physical wellness
Perkspot - offers exclusive or private discounts from approximately 900 merchants in a wide array of categories

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7000 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.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer including disability and veterans.

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 . 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.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment bank details photocopies of identification social security number or other highly sensitive personal information during the offer process and we NEVER do so via email or social media. If you receive any such request DO NOT respond it is a fraudulent request. Please forward such requests to for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.

Required Experience:

AR&D Associate Data AuditorCatalent Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop manufacture and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma bio...