Case Resolution Specialist
1080 U.S. Highway 202 Branchburg, NJ 08876
Bayside Solutions is seeking a Case Resolution Specialist to be part of our client’ s team. 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:
- The ‘ Case Investigation and Resolution’ department is the Center of Excellence for the resolution of global product complaints. The Scientist (CIR) is responsible for effective and timely resolution of global cases, including complaint investigations, risk assessments, case documentation, trending analysis and preparing reports, ensuring regulatory compliance and optimal levels of customer satisfaction. Also participates in the On-Boarding of new employees by providing product and process training and support. The ideal candidate has strong technical knowledge, expertise of assay workflow and system functionality, enjoys troubleshooting, and has a problem solving mindset.
- Accountable for the timely handling of individual cases (Inquiry, Complaint, Potential Reportable and Safety issues) according to ISO Quality System requirements and regulations, and needs of the Country Organizations including creation, acceptance, classification, investigation, complete documentation, on-site trouble-shooting and resolution of cases.
- Responsible for experimental design of complaint investigations, conducts investigation experiments, and analyzes data using statistical measures for determining a potential product performance issue.
- Assumes responsibility to ensure, by collaborating and interfacing with the BA and global functions, appropriate measures from cases are derived, including, but not limited to workarounds, in a timely manner.
- Initiates, monitors and ensures completion of complaint CAPAs and triggers appropriate preventive actions resulting from complaints.
- Provides information from cases in order to update product documentation.
- Assumes responsibility for timely communication of quality related information to the Country Organizations.
- Assumes responsibility for regular peer review of escalated cases.
- Supports initiatives and measures to maintain enhanced interfaces with country organizations and regional representatives.
- Provides audit and inspection support as requested.
- Contributes to the creation of regular reports to document on-market product quality and performance, to escalate critical issues to the responsible Life Cycle Teams and to define pro-active measures.
- Contributes to case-related trending to understand the scope of an issue.
- Supports regular review of quality of case handling, CAPA management and analyzes feedback on customer satisfaction to permanently optimize processes to increase quality and efficiency standards with a focus on customer, compliance and continuous improvement.
- Assumes responsibility to ensure risk assessments for product quality issues are complete
- May be responsible for training and mentoring new employees and other team members.
- The essential job functions and major contributions listed above are not intended to be an exhaustive list of all responsibilities, duties and skills. May be required to perform other duties as assigned to meet the CIR goals and objectives as appropriate.
- Other duties as assigned by management.
- Position will be remote. An ideal candidate will sit close to Branchburg NJ, Santa Clara, CA, or Pleasanton, CA.
Summary of Qualifications:
- Bachelor degree in life sciences, engineering or related field, or equivalent combination of education and work-related experience is required. Background in Molecular Biology, Microbiology, Genomics, NextGen Sequencing, Chemistry or related science is preferred.
- Must have 1 year of work experience in technical product support role, research and development setting, technical customer support role or related function.
- Proficient in technical writing is required
- Solid communication skills (written and spoken) in English are essential. Knowledge of additional languages is a plus
- Computer literate, with knowledge of e-learning, multimedia technologies
- Demonstrated analytical, solutions oriented and collaborative approach to problem solving
- Attention to details, technical orientation with excellent organization skills, solid problem solving, troubleshooting capabilities and negotiation attitude
- Very good presentation and communication skills
- Genuine empathy, patience, flexibility and ability to skillfully direct contacts to resolve issues in a timely manner
- Customer advocate and business orientation
- Knowledge of regulations and IVD standards, Good Manufacturing Practices (GMP)
- Experience with Molecular Biology techniques including PCR technology is preferred.
- Ability to problem solving and troubleshooting capabilities is nice to have
- Root Cause analysis knowledge is preferred
- Nice to have 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).
- Experience working with global cross functional teams is preferred.