Catalent Pharma Solutions Documentation and Investigation Specialist in Somerset, New Jersey
Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here (http://www.catalent.com/index.php/about-us/Catalent-Careers2)
Our Somerset location is the corporate headquarters for Catalent Pharma Solutions. This location houses our state-of-the-art laboratory, clinical, commercial manufacturing plant for oral dose forms in addition to being the Center of Excellence for Highly Potent Active Pharmaceutical Ingredients.
The Documentation and Investigative Specialist will report directly to the Leader, Operations Support.
This position will devise, execute and sustain all investigation and documentation processes for commercial and development activities relating to solid dose manufacturing. The Documentation and Investigation Specialist will work alongside the Operations Support Manager and liaise with other functional departments including but not limited to Formulations, Quality Operations / Engineering, Validations, Engineering and Metrology in leading quality and continuous improvement activities for process and technical documentation in the Operations department.
Drive the investigation process including Deviations, Customer Complaints, and related Trackwise Records in partnership with Operations, R&D and Engineering to create compliant, effective processes for project and technical documentation.
Collaboratively develop effective root cause analysis and CAPAs to minimize the potential for repeat deviations. Conduct Risk assessments to evaluate the impact of process deviations and complaints
Provide guidance and coaching on how to best document investigations, SOPs, work instructions, etc.
Edit Operations documents for clarity, consistency and completeness.
Work closely with management to identify training needs and requirements and implement technical and management development training programs to support business unit objectives.
Review SOPs, cGMP, Batch Records, product related technical information, protocols, etc. to ensure technical training materials developed are current and in compliance with regulatory agencies and Company procedures.
Provide direct support for customer/regulatory audits and responses to those audits inclusive of closure of regulatory commitments.
Develop new procedures and revise existing procedures as required.
Collect data and identify trends; report on key performance indicators to improve on time delivery of documents related to production and investigations.
Provide timely and accurate reports and assessments of problems or potential problems to the Operations Support Leader.
Assist in preparing the site for inspection by regulatory authorities.
Participate in regulatory inspections as required.
Contribute to process improvement initiatives across the operations function.
Report project status and site trends to Senior Management.
Comply with Health, Safety & Environmental responsibilities.
Other responsibilities as assigned.
BA/BS degree in science or pharmaceutical related field.
Minimum of 5 years of experience working in a pharmaceutical environment.
Experience in US FDA GMP, GDP and compliance/regulatory requirements. Experience in quality investigations and root cause analysis is a must.
Opportunity to work with a growing department with high visibility to Senior Leadership
Medical, Dental, Vision and 401K are all offered from day one of employment
19 days of paid time off annually + 7 paid holidays
Leadership Competencies for Performance and Development
Leads with Integrity and Respect
Demonstrates Business Acumen
Fosters Collaboration and Teamwork
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 www.catalent.com/careers to explore career opportunities.
Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. 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.
Catalent = Catalyst + Talent
Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us!
personal initiative. dynamic pace. meaningful work.
Catalent is the perfect place to grow your career if…
You enjoy the fast pace of a start-up, but want the opportunities and stability of a growing, publicly traded company (Listed on NYSE: CTLT).
You want meaningful work. From cough treatments to cancer-fighting drugs, biologics, and vitamins, we help develop, launch, and supply over 200 new products each year – more than any branded drug maker in the world!
You want to plant your career in a growing company. Over the last five years, Catalent has re-invested more than $2 billion back into the company and its people.
You are excited about learning, collaborating, and growing alongside a global diverse team. Our team of more than 11,000 comes to work every day ready to overcome new challenges with teamwork, advanced technologies, and a passion to deliver by putting patients first.
You want to make a global impact! From North America to Europe, Asia to Latin America, we have innovative science and manufacturing teams who are looking (https://catalent.wd1.myworkdayjobs.com/External) for YOU!
See how our teams are making a difference, while growing their careers and fulfilling our mission by putting patients first every day here (https://www.youtube.com/playlist?list=PLuUGqEwwnH7hBwFlrsfSOH_raQHu4hOBK) .