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Investigator

Summary

Exciting new opportunity with the Human Perfomance team in Hillerød!

Job Category

Environmental Health & Safety, Quality

Requisition Number

32977BR

Job Description

The Investigator is responsible for maximizing organizational learning and improvement from Quality and Safety deviations. The incumbent applies systematic and analytical cause analysis techniques inclusive of Human and Organizational performance principles to each investigation assigned. The Investigator identifies the best methodology for the given situation, facilitates investigation team meetings, conducts interviews, and collects and synthesizes data in order to identify causes that if addressed would prevent recurrence. In some situations the Investigator will facilitate Learning Teams as a collaborative approach to support cause analysis. The incumbent partners with stakeholders from all areas of the business to ensure actions taken as a result of findings prevent or mitigate the risk of future recurrence. The incumbent ensures effective communications to stakeholders and manages activities to ensure completion per expected regulatory and product release timelines. The incumbent ensures investigations are conducted in alignment with Quality Management System requirements and governing safety regulations, and presents investigative findings during audits as requested.

Primary Responsibilities
• Leads investigations for Quality and Safety deviations and incidents. Conducts Quality and Safety investigations with focus on performance improvement and risk reduction, in alignment with Quality Management System requirements and governing safety regulations. May lead complex and/or high impact investigations. Identifies root and contributing causes and makes recommendations to correct and/or prevent recurrence.
• Documents investigation reports and findings in designated Quality and Safety systems. Ensures required management and Quality approvals on final investigations while satisfying established due dates. Facilitates corrective and preventive action agreement with stakeholders
• Facilitates internal sharing of investigational findings and risk knowledge. Contributes to metrics related to investigation process and CAPA effectiveness

Qualifications

• A minimum of 5-8 years of experience in a lab and operations environment (industrial/plant experience preferred
• Demonstrated experience in systematic cause analysis methods, including Event & Causal Factor charting, Logic Fault Tree and similar techniques
• Strong facilitation skills and proven record to effectively lead cross-functional teams
• Strong technical writing skills and ability to synthesize information from multiple SMEs into a coherent, clear and concise narrative
• Ability to interpret technical information and documentation used for operations and production activities
• Experience in management of diverse stakeholders with strong interpersonal/influencing skills
• Ability to communicate effectively across organizations. Ability to balance resource demands from multiple internal customers
• Demonstrated experience in performance improvement with basis in Human and Organizational Performance principles
• Practical knowledge and application of cGMP, cGLP, EMEA, and OSHA compliance regulations and inspections plus experience interfacing with inspectors, investigators and/or agency personnel
• Strong interpersonal skills including the ability to negotiate and resolve challenges with poise, tact and diplomacy
• Strong oral and written communication skills to all employment levels and to PO&T Senior Leadership
• Demonstrated ability to analyze, extrapolate data, synthesize and determine recommendations, including the analysis of complex problems

Education

• B.S./Master’s degree in Engineering, Organizational Psychology, Industrial Safety, Forensics or a related scientific discipline

Employment Category

Full-Time Regular

Experience Level

Associate


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329717976Phoenix-f5c13a3a12017-11-30T20:09:40.720Investigator

Summary

Exciting new opportunity with the Human Perfomance team in Hillerød!

Job Category

Environmental Health & Safety, Quality

Requisition Number

32977BR

Job Description

The Investigator is responsible for maximizing organizational learning and improvement from Quality and Safety deviations. The incumbent applies systematic and analytical cause analysis techniques inclusive of Human and Organizational performance principles to each investigation assigned. The Investigator identifies the best methodology for the given situation, facilitates investigation team meetings, conducts interviews, and collects and synthesizes data in order to identify causes that if addressed would prevent recurrence. In some situations the Investigator will facilitate Learning Teams as a collaborative approach to support cause analysis. The incumbent partners with stakeholders from all areas of the business to ensure actions taken as a result of findings prevent or mitigate the risk of future recurrence. The incumbent ensures effective communications to stakeholders and manages activities to ensure completion per expected regulatory and product release timelines. The incumbent ensures investigations are conducted in alignment with Quality Management System requirements and governing safety regulations, and presents investigative findings during audits as requested.

Primary Responsibilities
• Leads investigations for Quality and Safety deviations and incidents. Conducts Quality and Safety investigations with focus on performance improvement and risk reduction, in alignment with Quality Management System requirements and governing safety regulations. May lead complex and/or high impact investigations. Identifies root and contributing causes and makes recommendations to correct and/or prevent recurrence.
• Documents investigation reports and findings in designated Quality and Safety systems. Ensures required management and Quality approvals on final investigations while satisfying established due dates. Facilitates corrective and preventive action agreement with stakeholders
• Facilitates internal sharing of investigational findings and risk knowledge. Contributes to metrics related to investigation process and CAPA effectiveness

Qualifications

• A minimum of 5-8 years of experience in a lab and operations environment (industrial/plant experience preferred
• Demonstrated experience in systematic cause analysis methods, including Event & Causal Factor charting, Logic Fault Tree and similar techniques
• Strong facilitation skills and proven record to effectively lead cross-functional teams
• Strong technical writing skills and ability to synthesize information from multiple SMEs into a coherent, clear and concise narrative
• Ability to interpret technical information and documentation used for operations and production activities
• Experience in management of diverse stakeholders with strong interpersonal/influencing skills
• Ability to communicate effectively across organizations. Ability to balance resource demands from multiple internal customers
• Demonstrated experience in performance improvement with basis in Human and Organizational Performance principles
• Practical knowledge and application of cGMP, cGLP, EMEA, and OSHA compliance regulations and inspections plus experience interfacing with inspectors, investigators and/or agency personnel
• Strong interpersonal skills including the ability to negotiate and resolve challenges with poise, tact and diplomacy
• Strong oral and written communication skills to all employment levels and to PO&T Senior Leadership
• Demonstrated ability to analyze, extrapolate data, synthesize and determine recommendations, including the analysis of complex problems

Education

• B.S./Master’s degree in Engineering, Organizational Psychology, Industrial Safety, Forensics or a related scientific discipline

Employment Category

Full-Time Regular

Experience Level

Associate

2018-01-26T02:00:34.357 Summary Exciting new opportunity with the Human Perfomance team in Hillerød! Job Category Environmental Health Safety, Quality Requisition Number 32977BR Job Description The Investigator is responsible for maximizing organizational learning and improvement from Quality and Safety deviations. The incumbent applies systematic and analytical cause analysis techniques inclusive of Human and Organizational performance principles to each investigation assigned. The Investigator identifies the best methodology for the given situation, facilitates investigation team meetings, conducts interviews, and collects and synthesizes data in order to identify causes that if addressed would prevent recurrence. In some situations the Investigator will facilitate Learning Teams as a collaborative approach to support cause analysis. The incumbent partners with stakeholders from all areas of the business to ensure actions taken as a result of findings prevent or mitigate the risk of future recurrence. The incumbent ensures effective communications to stakeholders and manages activities to ensure completion per expected regulatory and product release timelines. The incumbent ensures investigations are conducted in alignment with Quality Management System requirements and governing safety regulations, and presents investigative findings during audits as requested. Primary Responsibilities • Leads investigations for Quality and Safety deviations and incidents. Conducts Quality and Safety investigations with focus on performance improvement and risk reduction, in alignment with Quality Management System requirements and governing safety regulations. May lead complex and or high impact investigations. Identifies root and contributing causes and makes recommendations to correct and or prevent recurrence. • Documents investigation reports and findings in designated Quality and Safety systems. Ensures required management and Quality approvals on final investigations while satisfying established due dates. Facilitates corrective and preventive action agreement with stakeholders • Facilitates internal sharing of investigational findings and risk knowledge. Contributes to metrics related to investigation process and CAPA effectiveness Qualifications • A minimum of 5-8 years of experience in a lab and operations environment (industrial plant experience preferred • Demonstrated experience in systematic cause analysis methods, including Event Causal Factor charting, Logic Fault Tree and similar techniques • Strong facilitation skills and proven record to effectively lead cross-functional teams • Strong technical writing skills and ability to synthesize information from multiple SMEs into a coherent, clear and concise narrative • Ability to interpret technical information and documentation used for operations and production activities • Experience in management of diverse stakeholders with strong interpersonal influencing skills • Ability to communicate effectively across organizations. Ability to balance resource demands from multiple internal customers • Demonstrated experience in performance improvement with basis in Human and Organizational Performance principles • Practical knowledge and application of cGMP, cGLP, EMEA, and OSHA compliance regulations and inspections plus experience interfacing with inspectors, investigators and or agency personnel • Strong interpersonal skills including the ability to negotiate and resolve challenges with poise, tact and diplomacy • Strong oral and written communication skills to all employment levels and to PO T Senior Leadership • Demonstrated ability to analyze, extrapolate data, synthesize and determine recommendations, including the analysis of complex problems Education • B.S. Master s degree in Engineering, Organizational Psychology, Industrial Safety, Forensics or a related scientific discipline Employment Category Full-Time Regular Experience Level Associate11Jobnetf5c13a3a100000000000IDK_OFIR_02DKDanmark228DKK2018-01-25T00:00:000010https://www.biogen.com/content/corporate/en_us/careers/careers-search.html.html?searchkeyword=&category=&location=0EuropaDanmarkEuropaDanmarkSjælland & øerStorkøbenhavnAllerødEuropaDanmarkSjælland & øerNordsjællandFredensborgEuropaDanmarkSjælland & øerNordsjællandHillerød3031899BIOGEN (DENMARK) NEW MANUFACTURINGApS11Biogen Alle 13400HillerødDKDanmarkORS/blank.png155.9220039012.27590210
DKDanmarkDKDanmark
8Fuldtid46Permanent495845JobNet47000381000https://dispatcher.ofir.dk/statistic/register?context=FeedEntrySearchedCount&feedId=dc2beb84&entryId=f5c13a3ahttps://dispatcher.ofir.dk/statistic/register?context=FeedEntryDisplayCount&feedId=dc2beb84&entryId=f5c13a3ahttps://dispatcher.ofir.dk/statistic/register?context=JobApplicationInitiatedCount&feedId=dc2beb84&entryId=f5c13a3a&page=ShowJob&component=SendApplicationButtonhttps://dispatcher.ofir.dk/statistic/register?context=JobApplicationAppliedCount&feedId=dc2beb84&entryId=f5c13a3a&page=EmailApplyForm&component=SendApplicationButtonhttps://static.matchwork.com/company/logo/DK/ORS/SoMe/Ledelse_og_HR/Ledelse/5.jpgØnsker du et spændende job som Afdelingschef? Hos BIOGEN (DENMARK) NEW MANUFACTURINGApS tilbyder vi arbejdsplads med fokus på den enkelte medarbejder.12008001Dansk3Læse/ tale123204Afdelingschef6Ledelse351438320importimport_f5c13a3aDKDanmarkDKDanmarkda-DK