Complaint Analyst position

Integrated Resources, Inc

Horsham, Pennsylvania

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JOB DETAILS

JOB TYPE

Contractor

SKILLS

Analysis Skills, Biology, Biotech and Pharmaceutical, Business Administration, Business Skills, Clinical Research, Code of Federal Regulations, Customer Relations, Customer/Client Research, Documentation, English Language, External Audit, ICH Regulations, Information Technology & Information Systems, Internal Audit, Leadership, Manufacturing, Manufacturing/Industrial Processes, Marketing, Medical Equipment, Metrics, Physical Science, Process Analysis, Process Improvement, Product Testing, Project Management Certification, Project Management Professional (PMP), Project/Program Management, Quality Assurance, Quality Control, Regulatory Requirements, Rehabilitation Nursing, Resolve Customer Issues, Sales Administration, Standard Operating Procedures (SOP), Systems Maintenance, Technical Support, Time Management, Track Customer Issues, Training/Teaching, Willing to Travel

LOCATION

Horsham, Pennsylvania

POSTED

Today

Complaint Analyst PositionA Few Words About Us - Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.This position is with my direct clientJob DescriptionComplaint Management:Process and analyze product complaints according to Policies and Standard Operating Procedures.Evaluate product quality complaints for seriousness, correctness and consistency of categorization.Assign complaints to appropriate investigational sites.Communication of potential serious PQC's in a timely manner, as appropriate.Retrieval of field samples (US only), as applicable.Ensure all relevant complaint data is obtained.Partner with customers (JJQS, Internal JSC Manufacturing Sites, External Business Partners, Regional ESIQ organizations, Call Intake Centers, Global Medical Safety/LSOs, Marketing, Sales Administration, Brand Protection, etc) to gain knowledge of products and processes.Participate within and monthly execution of the PDQ complaint monitoring process to ensure standard process is followed, and data is consistent and of high quality to assist with correct decision making.Compile product and site-specific complaint trending data and complaint closure metrics as requestedSupport internal and external audits and inspections.Participate within and/or facilitate special projects.Develop and deliver training for colleagues and customers on complaint handling process, product specific training, and complaint handling system updates/changes.Business Relations:Partner with customers (JJQS, Internal JSC Manufacturing Sites, External Business Partners, Regional ESIQ organizations, Call Intake Centers, Global Medical Safety/LSOs, etc) to continuously identify, assess, and improve complaint handling processes.Communicate the value of consistent complain data to business and provide direct guidance and direction according to complain management standards and processesBuild consensus across functional areasDrive technical and process improvements. Influence change.Solicit customer feedback.Documentation:Execution of the development, revision and/or maintenance of applicable department WI's and SOPs.Identify, assess, and implement process improvements to the standard process.Related Experience :Describe the types of experience and typical number of years required for this role:4+ years of related experience including Quality Assurance and/or Quality Control, including experience working in pharmaceutical and/or Medical Device or other related or highly regulated industry.Preferred experience supporting many/all aspects of the complaint vigilance life cycle for pharmaceutical, device, and/or cosmetic products. Device and pharmaceutical strongly preferred.Knowledge of medical safety environment and regulationStrong communication, organizational and project management skills.Prior demonstrated success at Analyst 2 level or equivalent.List job specific competencies/skills required:Can work independently in a global environment/virtual teamGlobal mindsetAbility to lead change initiatives, develop strong effective relationships with key resources and decision makers.Demonstrated knowledge and expertise of manufacturing processes, complaint vigilance global regulatory requirements, including 21CFR parts 210 and 211, ICH Q10 and CFR 820.198.Ability to support technical teams toward business goals.Ability to allocate and balance competing prioritiesCompetency in understanding system functionality in relation to process requirements.Fluent in English, ability to travel internationally as needed. Ability to work outside of normal working hours when needed.Leadership Competencies:.Education:BA/BS - RequiredMA/MA/MBA – DesirableSubject or Major:Physical / Life Science (Equivalent experience is acceptable)Certification:Project Management PMP – DesirableAdditional InformationRegards,Sweta VermaIT RecruiterIntegrated Resources, Inc.Inc. 5000 - 2007, 2008, 2009, 2010, 2011, 2012 & 2013 (7th Year)Certified MBE I GSA - Schedule 66 I GSA - Schedule 621I I GSA - Schedule 70

Complaint Analyst position

Integrated Resources, Inc

Horsham, Pennsylvania

About the Company

Integrated Resources, Inc

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