The Data Auditor reports to the Group Leader of Analytical Research & Development
St. Petersburg is our primary soft gel development and manufacturing facility in North America with capacity of 18 billion capsules per year. ?Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve difficult development and manufacturing challenges.??
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 Data Auditor role is critical to our patients as it provides critical review of data for NDA and ANDA submissions with patient safety in mind, executing with efficiency always. Quality, safety and on-time delivery is a must to be successful in this role.
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!?
This is a Second Shift Position: working hours are 2:00 pm-10: 30 pm or 3:00 pm- 11:30 pm
The Role (daily responsibilities)
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.
Approve analytical documents as the reviewer against applicable specifications/procedures.
Perform data certification in the electronic GLIMS system if applicable.
Assist in complying with any other company and /or departmental objectives as directed by AR&D management.
Deliver on commitments to meet customer expectations.
The Candidate (requirements)
Minimum BS degree in Chemistry, Biology, Microbiology or related sciences.
Minimum of 4 years relevant pharmaceutical laboratory/analytical experience.
Working knowledge of cGMPs regulations.
Ability to effectively communicate with co-workers.
Prior HPLC/GC Instrumental experience required.
Good organizational skills required. Motivated, self-started, team player.
Cross functional exposure to other areas of Operations?
Medical, Dental, Vision and 401K are all offered from day one of employment?
152 hours of paid time off annually + 8 paid Holidays
We will identify candidates based on the following Catalent Competencies:?
Leads with Integrity and Respect?
Demonstrates Business Acumen?
Fosters Collaboration and Teamwork?
Engages and Inspires?
Coaches and Develops?
Internal Number: 0052469
About Catalent Pharma Solutions
With over 85 years of serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance, and ensuring reliable global clinical and commercial product supply. Catalent employs over 1 4,000 people, including over 2,400 scientists and technicians, at more than 45 facilities, and in fiscal year 2020 generated over $3 billion in annual revenue. Catalent is headquartered in Somerset, NJ.
Mission: Our mission is to develop, manufacture, and supply products that help people live better, healthier lives.