Senior Lead Investigator, Technical Services
Location
Saint Petersburg, FL | United States
Job description
Position Summary
St. Petersburg is our primary softgel development and manufacturing facility in North America with a capacity of 18 billion capsules per year. The featured RP Scherer softgel technology is a proven oral drug delivery solution to enhance bioavailability of poorly soluble Rx and OTC drug candidates. Non-gelatin based OptiShell® and Vegicaps® capsules expand the range of molecules into softgel, ideal for challenging fill formulation. Within the Catalent network, we offer a broad range of integrated formulation.
Technical Services is responsible for providing commercial technical support over the lifecycle of all products, driving continuous improvement throughout the manufacturing environment facilitating commercial technology transfers and ensuring Launch Excellence during the new product introduction process.
The primary tasks performed by the
Senior Lead Investigator will include working on proper investigation and documentation of the deviations, root cause analysis, impact, and corrective actions for the deviation management process for the site. The
Senior Lead Investigator will represent and collaborate with members of multiple departments and QA to ensure all deviations are investigated and documented properly and timely and will ensures that effective corrective and preventive actions are instituted in a timely manner and that they are effective. The position will include the evaluation of technical data to identify and remediate trends.
Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. 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 - Complete investigation of deviations and ensure compliant documentation.
- Effectively compile and interpret data and identify the impact of deviations to product quality in collaboration with subject matter experts. This includes clearly defining problems, collecting, and organizing existing data, comparing causes to facts, identifying probable root causes, conducting interviews and SME discussions, and determining the best solutions for improvement of manufacturing processes, standard operations procedures (SOPs) and supply chain business practices.
- Facilitate completion of site metric reporting related to deviations (daily, weekly, monthly, and quarterly). Effective communication with management regarding status of deviations. Assist with Management Review meetings.
- Evaluate data and identify potential trends. As trends are identified, work with functional areas to develop remediation plans.
- Review supporting documentation including batch documentation, ancillary documentation, test results /CoAs, Product specifications, training records, SOPs, calibration records, packaging and validation protocols, and other technical documents in support of the investigation.
- Ensures compliance with cGMPs and departmental procedures by promptly reporting non-compliance issues to management. Ensures the adherence to the standards of quality ruled by the current Good Manufacturing Practices and the Company's Quality Policies.
- Participate in additional quality initiatives as required.
- Other duties as required in support of Catalent Pharma Solutions high performance, such as but not limited to, assisting site management in driving, and enforcing cGMPs and mentoring other individuals within the organization in the area of compliance-deviation management.
The Candidate - Requires a bachelor's degree in a relevant business discipline.
- Requires a minimum of 3 years' experience in pharmaceutical manufacturing.
- Requires a minimum of 3 years' experience with investigation systems or deviation management. Solid understanding of cGMPs as they apply to documentation and deviation systems. Direct, hands-on experience with deviation management and deviation management systems; knowledge of TrackWise is preferred.
- Must have experience in advanced root cause analysis tools (Fishbone, 5-Why, Brainstorming, FMEA, Process Mapping, Error-proofing, etc.). Demonstrated facilitation, problem solving, and analytical skills.
- May be required to sit for long periods of time, while reading or preparing documents. The individual may also be required to stand or walk. Ability to work effectively under pressure with constantly changing priorities and deadlines.
- Must be able to meet the gowning requirements for the manufacturing areas. Required to sit, stand, walk regularly and occasionally lift 0-15 pounds. Ability to access and move throughout production area(s) and office area(s) and use the proper safety precautions as required. Ability to use required office equipment. Specific vision requirements include reading of written documents and use of computer monitor screen frequently.
Why You Should Join Catalent - Competitive medical benefits and 401K
- 152 hours of PTO + 8 Paid Holidays
- Dynamic, fast-paced work environment
- Opportunity to work on Continuous Improvement Processes
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 .
Job tags
Salary
