Joseph Job

• Initiate, update, and optimally close all product safety, medical device/IVD complaints.
• Lead all CAPA program activities including taking ownership of CAPA program and driving changes where appropriate.
• Establish and manage processes for implementing CAPAs and complaint handling in accordance with 21 CFR820 and ISO 13485.
• Advise manager of any potential reportable product safety incidents and work with Regulatory Affairs as appropriate.
• Work with Service organization to ensure accurate follow-up activities with the customer have taken place.
• Work with product investigators to ensure timely and effective investigation. Ensure adequate investigation has taken place for CAPAs and Root Cause Analysis is complete and appropriate for the issue
• Report CAPA and complaint trending data and metrics to management during quality reviews.
• Work cross functionally to initiate CAPAs from all identified sources, ensure timely completion of CAPA planning activities such as root cause analysis, containment, immediate corrections, corrective action plan and verification of efficiency plans.

• Review complaints assigned daily for reportability.
• Review ancillary system sources information to ensure complaint records are accurate.
• Assure complaints are initiated and processed in a timely manner.
• Provide MDR Submission team with quality records in preparation for submission to FDA.
• Work cross-functionally with internal teams as well as external customers to obtain relevant updated complaint information
• Assisted in creating templates used by Post Market Surveillance Team.
• Perform Good Faith Efforts for product return and to obtain required information for complaint files.
• Document any verbal conversations in the Diligence Log and attached any written correspondence to the complaint file.
• Determine whether additional information is required in order to make a preliminary MDR file/no file decision per FDA 21CFR803.
• Review reported event description and ensure intake code is aligned with event and accurate.
• Review all final codes and ensure accuracy.

• Conduct Routine testing of raw materials, In-process, stability and finished goods samples from the manufacturing process step.
• Investigates customer complaints and obtains data for customer inquiries that are relevant to QC.
• Responds to internal and external customer inquiries and requests as relevant to product quality or integrity.
• Conduct chemistry testing using LCMS, HPLC, UV/Vis, Wet Bench chemistry, TOC, Conductivity, Raman spectroscopy, pH and others.
• Conduct microbiological testing such as bioburden and endotoxin.
• Test environmental sampling (EM) for GMP rooms.
• Perform EM Trending
• Conduct routine QC lab cleaning and maintenance.
• Hands on experience doing equipment preventive maintenance or calibration.
• Conduct shipping inspection of Finished Goods
• Conduct QC reagent inventory and order reagents and supplies
• Assist in QC reagent qualification and studies
• Trend EM and QC data results
• Document, analyze, and interpret QC and experimental data
• Management of contract testing labs for in-process and final release assays
• Provides troubleshooting support for analytical equipment (LC-MS, HPLC, GC)

• Accession patient samples in a CAP and CLIA certified BSL-2 lab
• Identified issues that may adversely affect the quality of test results and reporting them to appropriate representatives to ensure prompt resolution.
• Work with our Client Services team to resolve missing information cases, data discrepancies and any other issues related to sample processing within the lab using platforms including Jira and Salesforce.
• Assist in general upkeep of the laboratory (i.e., organizing, stocking, lab equipment maintenance)
• Maintain strict standards of quality and assist with QC and QA activities
• Ad-hoc projects as directed by the team leader
  
  
  
  
  

• Directed patients to exam rooms, fielded questions, and prepared patients for physician examinations.
• Taught patients about medications, procedures, and care plan instructions.
• Sanitized, restocked, and organized exam rooms and medical equipment.
• Supported duties for diagnostic and technical treatment procedures, such as setting up and operating special medical equipment and apparatus.
• Kept medical supplies in sufficient stock by monitoring levels and submitting replenishment orders before depleted.
• Performed clerical duties, such as word processing, data entry, answering phones, and filing.
• Obtained client medical history, medication information, symptoms, and allergies.
• Completed clinical procedures and gathered patient data for interpretation by physician.
• Collaborated with medical and administrative personnel to maintain patient-focused, engaging, and compassionate environment.

• Built strong relationships with members to promote health, wellness, and available services.
• Enhanced team performance against goals by coaching and motivating clients.
• Demonstrated safe and correct forms for each exercise and piece of equipment.
• Provided individual health coaching to help clients optimize personal choices.
• Assisted and coached clients during physical exercises to promote the safety of clients and effectiveness of routines.
• Understood client limitations based on medication or physical disabilities while building exercise plans.
• Maintained client records for future use and for reference by other healthcare providers.

• Observed patients awaiting therapy or transportation to note needs and handle situations appropriately.
• Prepared patients for treatment by positioning, dressing, or removing external supports.
• Assisted patients during ambulation to prevent injuries.
• Administered structured activities to socialize patients.
• Encouraged and attended to patients' physical needs to facilitate and attain therapeutic goals.
• Reported patients' progress, attitudes, and accomplishments to supervisors or therapists.
• Observed patients undergoing treatments and reported status changes to the supervising therapist for immediate attention.
• Protected patient and personnel safety by cleaning work areas and disinfecting equipment after treatments.
• Transported patients to and from treatment areas using wheelchairs and assistive devices.

• Conferred with staff to discuss and evaluate patient information for planning, modifying, and coordinating treatment.
• Provided treatment to patients suffering from sports-related injuries to prevent loss of sensitivity as well as mobility.
• Coordinated daily activities of patients to support them in their individual care programs.
• Recorded patient status in progress notes.
• Updated and maintained charts to reflect on patient progress and treatments.
• Enforced safety procedures with all patients.
• Followed all HIPAA rules and regulations regarding patient confidentiality.
• Assisted Physical Therapists to initiate different patient care plans in outpatient setting.