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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 analysis. In 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 and compliance, 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 (RoA’s) and Certificate of Analysis (CoA’s)

+ 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 Bachelor’s 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**

+ Master’s 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 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.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers (https://careers.catalent.com/us/en) 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 [email protected] . 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 [email protected] for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .