Data Auditor, AR&D

Position Summary

St. Petersburg is our softgel development and manufacturing Center of Excellence in North America, with capacity of 18 billion capsules per year. We are the inventors of the rotary die encapsulation process featured in RP Scherer softgel technology which delivers a consumer preferred oral drug delivery solution which can enhance bioavailability of poorly soluble API. Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve difficult development and manufacturing challenges.

The Data Auditor will Independently review and audit analytical data including notebooks, chromatographic data, validation protocols and reports and other analytical data protocols and reports. The Data Auditor will document and communicate results both to the analysts whose work is under review and to laboratory management when required. Maintain proper records in accordance with all SOP's and policies.

The Analytical Research and Development (AR&D) laboratory supports evaluation and testing of raw materials, excipients, APIs, in-process, and finished product samples. AR&D also performs development and validation of methods used to support release and stability testing of non-commercial products and materials. The department provides analytical services to manufacturing, process development, validation, and new material qualifications. AR&D interacts with clients to provide not only research and testing of products, but also support CMC development activities in support of client regulatory filings. Activities are performed in accordance with specifications, standard operating procedures, approved test methods and/or protocols, regulatory requirements, and St. Petersburg’s Quality departmental policies.

If you share a passion for patient care in the growing world of pharmaceutical manufacturing and would like to be part of a global drug development and delivery leader, then this might be for you!

The Role

• Perform audits of analytical data to include but not limited to laboratory notebooks, chromatographic raw data, analysis reports, and other analytical data as required, against test methods, specifications, and other reference documents.

• Initiate/facilitate/review documented deviations/process discrepancy reports/investigations of any reported or observed nonconformance found relative to data quality.

• Approve analytical documents as the reviewer against applicable specifications/procedures.

• Perform data certification in the electronic LIMS system if applicable.

• Actively participate in corrective actions and continuous improvements.

• Assist in complying with any other company and /or departmental objectives as directed by AR&D management.

• Deliver on commitments to meet customer expectations.

• All other duties as assigned.

The Candidate

• Requires a minimum of: MS in scientific field with 3 plus years, or BS in scientific filed with 5years or AS in scientific filed with 10 years in the analytical lab

• Analytical laboratory / Pharmaceutical and or GMP experience preferred

• Required to wear proper PPEs when auditing equipment and logbooks

• Ability to work flexible schedule for business needs (modified days and times

• Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds.

• Be accessible to manufacturing, laboratory and office staff.

• Vision requirements include reading of English documents and distinguish color

Why you should join Catalent:

• Defined career path and annual performance review and feedback process

• Diverse, inclusive culture

• 19 days of PTO 8 paid holidays

• Several Employee Resource Groups focusing on D&I

• Dynamic, fast-paced work environment

• Employee Stock Purchase Program

• 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

• Competitive salary with bonus potential

• Community engagement and green initiatives

• Generous 401K match and Paid Time Off accrual

• Medical, dental and vision benefits effective day one of employment

• Tuition Reimbursement – Let us help you finish your degree or earn a new one!

• GymPass program to promote overall physical wellness

• Perkspot - offers exclusive or private discounts from approximately 900 merchants in a wide array of categories

We will identify candidates based on the following Catalent Competencies

• 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 is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

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 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.

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 spam@catalent.com for us to investigate with local authorities.