1080 US Hwy 202 South, Building 500, Roo
Industry: Clinical & Scientific
Job Number: 16246
Bayside Solutions is seeking a Case Resolution Specialist to be part of our client’ s team in the Branchburg, NJ. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com
Case Resolution Specialist:
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- Assumes accountability for the management of individual cases (Inquiries, Complaints, PRI/PSIs) according to regulatory and ISO Quality system requirements and needs of the Country Organizations including creation, acceptance, classification, investigation, complete documentation, on-site trouble shooting and resolution of cases in a timely manner.
- Contributes to experimental design of investigations to ensure an efficient approach for root cause analysis.
- Ensures, by collaboration and interfacing with BA and global functions, appropriate measures from cases are derived, including, but not limited to workarounds.
- Assumes responsibility for timely communication of quality related information to the Country Organizations.
- Assumes responsibility for providing information from cases in order to update product documentation.
- Contributes to initial and continuous knowledge transfer from manufacturer, R&D or GCS for new products in the project phase to ensure availability of comprehensive system knowledge.
- Supports initiatives and measures to maintain enhanced interface with Country Organizations and regional representatives
- Supports constant evaluation of global case resolution vs. regional and local practice
- Supports creation of regular reports to document in-market product quality and performance
- Permanently optimizes processes to increase quality and efficiency standards with focus on customer, compliance and continuous improvement.
Summary of Qualifications:
- University degree of applied science (FH) or engineering (TS) or equivalent professional experience
- Vocational training in technical area completed with a maturity certificate and several years of work experience
- Work experience in the area of medical technology in either 1st or 2nd level support or R&D related functions
- Knowledge of the diagnostic market
- Knowledge of varied regulatory requirements and quality practices, especially in the area of complaint management (e.g., 21 CFR 820.198, ISO 10002, ISO 9001, ISO 13485)
- Intercultural skills as well as an analytical and solution-oriented way of thinking
- Strong communication skills in English (written and spoken) are essential
- Detail, technical orientation with excellent organization skills, strong problem solving, troubleshooting capabilities and negotiation attitude.
- Knowledge of regulations and IVD standards, Good Manufacturing Practices (GMP).
- Computer literateness, knowledge of e-learning and multimedia technologies.
- Very good presentation and communication skills. Experience in technical writing.
- Genuine empathy, patience, flexibility and ability to skillfully direct contacts to resolve issues in a timely manner.
- Strong customer and business orientation.
- Knowledge of additional languages is a plus