Data Review Auditor Jobs

Data Review Auditor

The Position

Catalent’s Greenville, N.C. facility specializes in end-to-end turn-key solutions for oral solid dosage forms, including integrated formulation development, analytical services, commercial manufacturing, and packaging. This state-of-the-art facility has had over $100M of investments in recent years and features fit-for-scale capacity with potent handling capabilities, ideal for orphan or targeted drug development.

The Data Review Auditor is responsible for independently reviewing and auditing analytical data including notebooks, chromatographic data, relevant electronic data records, and analytical data reports. The Data Review Auditor documents and communicates trends and comments/observations found to analysts and laboratory management when work is under review as required. All records and processes followed are to be in accordance with SOPs and policies.

The Role

• Assist in complying with any other company and/or departmental objectives as directed by analytical management
• All other duties as assigned.
• Maintain proficient knowledge in the use of Empower and other software-based systems as well as current guidelines for review of electronic data; perform supervisory sign-off for electronic reports
• As the reviewer, approve analytical documents against applicable specifications/procedures
• Compare laboratory data against specifications and trend data where applicable to determine if results meet requirements
• Initiate/facilitate/review documented deviations/process discrepancy reports/investigations of any reported or observed nonconformance found relative to data quality
• Interpret data and make recommendations to management for improvement or potential concerns
• Conduct peer review of routine and complex laboratory experiments for accuracy and provide guidance to junior team members to ensure future compliance
• Independently perform audits of analytical data to include, but not limited to laboratory notebooks, chromatographic raw data, relevant electronic data records, analysis reports, and other analytical data as required, against test methods, specifications, and other reference documents

The Candidate

• PhD in a science-related field with at least of 1 year of experience in a laboratory setting.
• Bachelor’s degree in a science-related field (e.g. Biology, Chemistry, Pharmaceutical Sciences) with 3 years of experience in a laboratory setting.
• Ability to communicate orally with customers, vendors, and co-workers.
• Good manual dexterity for the use of common laboratory equipment and office equipment such as computers, calculator, copiers, and fax machines.
• High school diploma or equivalent with at least 6 years of experience in a laboratory setting.
• Individual may be required to sit, stand, walk regularly and occasionally lift up to 20 pounds..
• Master’s degree in a science-related field with 2 years of experience in a laboratory setting.
• At least 1 year of experience in the pharmaceutical industry reviewing GMP documentation and processes required.
• Regular use of telephone and email required. Hearing, vision, and speaking within normal ranges is essential for normal conversations, to receive ordinary information and to prepare or inspect documents.
• Associate degree in Biotechnology, Chemistry or equivalent science degree with 4 years of experience in a laboratory setting.

Why You Should Join Catalent

• 19 days accrued PTO + 8 paid holidays
• Generous 401K match
• Tuition Reimbursement – Let us help you finish your degree or earn a new one!
• Employee Stock Purchase Program
• Several Employee Resource Groups focusing on D&I

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 [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.