Address
Form of workComplaints Specialist
The Position
The Complaints Specialist is responsible for batch record review and customer complaint investigation and technical writing and internal data management related to the quality and/or regulatory disciplines at the Morrisville site.
The Role
The Candidate
Why You Should Work At Catalent
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.
California Job Seekers can find our California Job Applicant Notice HERE.
The Position
The Complaints Specialist is responsible for batch record review and customer complaint investigation and technical writing and internal data management related to the quality and/or regulatory disciplines at the Morrisville site.
The Role
- Initiation, investigation and responding to customer complaints.
- Complaint initiation in TrackWise system, Initial customer notification.
- Batch record review, data gathering and other investigation related support for complaints.
- Compiling and generation data in support of complaints, Continuous Process Verification (CPV) and Annual Product Reviews (APRs) for all commercial
- customers.
- Metric/dashboard maintenance; includes collecting data, producing graphs/charts/ summarizing data and merging into uniform templates.
- All other duties as assigned.
The Candidate
- Bachelor of Science degree in related field with 3-4 years of experience in the pharmaceutical industry preferably in Quality function.
- Full understanding of FDA and EU cGMPs and DEA regulations pertaining to clinical trial and commercial manufacturing.
- High level of attention to detail.
- Full complement of business computer literacy skills (e.g., word processing, spreadsheets, database software, etc.) is required.
- Proficient in problem solving and analytical skills.
- Proficient in technical investigations, batch record review and technical writing.
- Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
- Review documentation for accuracy and completeness.
- Strong computer and appropriate communication skills (both written and oral) allowing direct interaction with outside suppliers, RTP internal staff.
- Should be familiar with cGMP and safe work practices.
- Demonstrated ability to read, write, and speak clear English.
- Frequent sitting, walking, reading of written documents and use of computer monitor screen, writing, talking, carrying, listening.
- Occasional lifting and/or moving up to 30 pounds.
Why You Should Work At Catalent
- Spearhead exciting and innovative projects
- Fast-paced, dynamic environment
- High visibility to members at all levels of the organization
- 152 hours of PTO + 8 paid holidays
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.
California Job Seekers can find our California Job Applicant Notice HERE.
