AddressDescription
Janssen Ortho LLC, a member of Johnson & Johnson's family of Companies, is recruiting for a Specialist Quality System-Complaints to be located in Gurabo, PR.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
Are you interested in making a difference in a thriving diverse company culture, that celebrates the uniqueness of our employees and is committed to inclusion? Apply today for this exciting opportunity!
In this role the Specialist Quality System-Complaints, under the direction of the QA Complaint Lead, will assure the complaint's handling is maintained in compliance and in accordance to established company and corporate standard operating procedures, policies, rules, and regulations as well as in accordance with current GMP guidelines.
Key Responsibilities:
- Partners with Operations Department to support the customer complaints investigation process.
- Performs physical field sample receiving activities, including decontamination of samples if required.
- Evaluate data to perform weekly Quality System Complaints Department Metrics.
- Apply statistical techniques to track and analyze process.
- Modify, review and approval of QA System documentation such as Work Instructions, Standard Operating Procedures Reports and forms as required.
- Actively participate in projects, programs, safety and environmental training, cGMP, SOPs, and others as required and/or special activities that the company promotes to foster employee involvement and their professional development/growth.
- Escalate issues to the Site Quality Head and Sr Manager Quality Assurance.
Qualifications
Education:
- A minimum of a bachelor’s degree is required . Focus degree on engineering or science in Pharmacy, Chemistry, Biology or related Sciences is preferred. A MA/MS/MBA or related science is preferred.
Experience and Skills:
Required:
- Minimum of two (2) years of experience in the Pharmaceutical Industry is required.
- Excellent technical writing skills with ability to organize information in a sequence that makes sense to reader is required.
- Strong problem solving/troubleshooting and decision-making skills is required.
- Strong influencing skills regarding quality goals is required.
- Customer focus with excellent QA Judgment and Sense is required.
- Ability to build relationships with good interpersonal skills to overcome barriers to communication is required.
- Ability to manage complexity and conflict is required.
- Ability to work in team environment and to handle multiple tasks is required.
- Proficiency in MS Office programs (PowerPoint, Word, Excel and Outlook) is required.
Preferred:
- Experience in the QA Compliance Areas with comprehensive knowledge/understanding of domestic and international guidelines and regulations, cGMPs and pharmaceutical manufacturing & packaging, and quality control activities for different dosage form types is preferred.
- Strong Project Management Skills is preferred.
- Knowledge in Investigations, documents, inventory and complaints management systems is preferred.
Other:
- Proficiency in English and Spanish (oral and written) is required.
- Requires up to 10% travel.
- This position requires availability for working irregular shifts, frequently requires working extended hours, and might be required to work on holidays and weekends .
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .
