Amgen Jobshttp://www.amgen.jobs2012-05-26 20:36:57.846093NLDBredaAuto req 15730BR Job Posting Title Sr Associate QA Career Category Quality Employee Subgroup Salaried FT Country (State/Region) The Netherlands Location (City) Breda Amgen Job Description Objective - To provide QA guidance and support in the production area at Amgen Breda - To perform batch record review of batches assembled, packaged and labeled and contract manufacturers. - To establish effective working relationships with Production, Warehouse, Maintenance and Engineering, QA Management and the Qualified Person Position Specific tasks: - Provide daily guidance and support to Production staff in regards to compliance with Standard Operating Procedures and Work Instructions. - Act as a first point of contact in case of production queries (quality related) during packaging and labeling operations. - Review and approve batch production record data entries before production activities take place - Perform finished product checks during (commercial) production runs - Compile and review batch records for lots assembled, packaged and labeled and contract manufacturers in preparation for disposition by Qualified Person. - Act as author for operational SOP’s and Work Instructions - Review of operational SOP’s and Work Instructions - Review and approve class I Non Conformances - Initiate and own QA Non Conformances as needed. In this job you work in 3 shifts (including night shifts) Basic Qualifications - MBO or Bachelor’s degree in Life Sciences or related field or the equivalent combination of education and/or experience. - Typically 3 years of related Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry with experience in batch record review and investigations. - Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and/ or Good Clinical Practice (GCP) knowledge with the ability to interpret and apply in mainly routine cases. - Manufacturing and/or Quality analytical processes and operations. - Fluent in English language. Preferred Qualifications - Fluent in Dutch language2012-05-22 19:48:28NetherlandsAmgenNone15730BRNoneBreda, NLD28868677http://www.amgen.jobs/xml/28868677/jobIRLDun LaoghaireAuto req 15464BR Job Posting Title Sr Associate QA Career Category Quality Employee Subgroup Salaried FT Country (State/Region) Ireland Location (City) Dun Laoghaire Amgen Job Description Job Description Position Title: QA Snr Associate Reports to: QP Group/Division: Amgen Dun Laoghaire Department: QA Shift Yes 24/5 Position Summary: This job specification outlines the general responsibilities associated with the role of QA Snr Associate at ADL. The site is focused on continuous improvement of all work processes and practices and all colleagues are required to be flexible in this regard. This means that they may be asked to carry out additional work functions that are not described in this specification but are associated with their role. The QA Snr Associates duties are as follows; • Compiles QC and Manufacturing batch records and reviews for compliance to cGMPs and Product Licenses. • Review and approve Master Batch Records • Review non conformances for completeness • Prepare the agenda for Site Quality Review Team and submits non conformances for review/discussion. • Prepares the SQRT minutes. • Assigns expiry date to products. • Prepare deviation trend reports bi annually to establish any evident trends. • Schedules products to be placed on the stability program • Status changes and yields product on the computer system • Prepares non conformance reports for shipments as required • Tracks CAPA’s detailed in non conformance reports • Writes, reviews and approves Standard Operating Procedures in accordance with Amgen Policies • Prepares Monthly Metrics. • Ensure compliance with Amgen procedures • Performs Quality Audits to ensure compliance with cGMPs • Maintains databases and other informational systems as necessary. • Prepares the KPI reports as required. • Complies with responsibilities as outlined in the site Safety Statement section 3.6. • Performs all tasks with due care and attention and in accordance with Good Manufacturing Practices and Amgen requirements, policies and procedures. • Participates in a learning and development programme which will include goal setting, annual performance reviews and individual development plans. • Is a champion for safe working practices and safety initiatives within their functional area. Basic Qualifications Education: Third level qualification, preferably to degree level, in a Science discipline. Experience: Minimum three years industrial experience or equivalent Preferred Qualifications Knowledge and training in QMTS, SAP, EBR and Maximo Strong organizational skills and ability to manage multiple tasks at one time Ability to follow assignments through to completion and meet timelines Self motivated Strong communication skills (both written and verbal) Demonstrated ability to work as both a team player and independently Ability to evaluate documentation and operations according to company procedures Ability to make decisions independently or elevate to management, as appropriate in an environment that balances business need, quality and compliance risk Strong word processing, database and spreadsheet application skills2012-05-17 20:58:26IrelandAmgenNone15464BRNoneDun Laoghaire, IRL28771078http://www.amgen.jobs/xml/28771078/jobUSAThousand OaksAuto req 14257BR Job Posting Title Director, Quality Engineering- Drug Delivery Career Category Quality Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The successful Director of Device Quality Engineering will lead and build a dynamic team that supports all new product development across the organization. In this high profile assignment you will lead a team of direct reports (Quality Engineers) responsible for design assurance for new and existing technology. This team is responsible for accurate, independent evaluation of Design History File documentation, Design intent and Design Quality. A key driver of success in this role is to translate design requirements into processes that ensure quality attributes in the design are maintained and are practical for manufacturing. You also will be the Device Quality Project lead on various high profile combination product teams. The candidate will work closely with Device Engineering to facilitate the development of innovative technology in a timely manner. Programs are focused on early development through transition to manufacturing with some sustaining work and will include risk management, reliability and failure analysis, and quality planning. Other responsibilities include independently determining appropriate test, verification and validation parameters to ensure components and products meet specifications requirements. The incumbent should have an understanding of drug product and drug product development requirements. Key Responsibilities: • Plans, conducts and executes design control activities requiring judgment in the independent evaluation, selection and the substantial adaptation of best practice engineering techniques, testing procedures and criteria. • Ensure team works closely with product development engineering and the supplier/contractor team to establish the system design specifications and product requirements. • Ensure team works closely with design, development, quality, regulatory, and the supplier/contractor team to establish and document the master verification and validation plans in conformance with the system design specification and sound testing principles. • Assists in the planning, coordinating and execution of design verification and validation testing to directly support the master verification and validation plans, including any additional activities such as HALT/HASS and IEC 60601-1-x testing, HFE studies, clinical trials and other standardized test methods. • Participates with the engineering team to establish and drive the design FMEA, FMECA and other risk related activities (ISO14971). • Facilitate the achievement of business goals for device reliability, quality, customer satisfaction, cost and safety by identification, development, and accomplishment of key initiatives supporting the business objectives and operational goals for device quality improvements, customer satisfaction, supplier and component initiatives, and safety. • Product reliability design improvements by ongoing research, design and further development of existing products to continuously improve device reliability, quality, and customer satisfaction. Validated product changes with completed documentation that meets or exceeds established guidelines, plus well-documented research/analyses that support decisions and conclusions. • Validation of supplier processes and support of supplier/contractor Quality Agreements. Basic Qualifications • Doctorate degree & 4 years of directly related experience OR • Master’s degree & 8 years of directly related years OR • Bachelor’s degree & 10 years of directly related experience AND • 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications • Advanced degree in an Engineering discipline, or other Engineering/Life Sciences related discipline and 10 years of business experience, leading development organizations in multiple parallel and virtual development environments. • 4 years of Quality managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources and have lead the commercial launch of a medical device. • CQA, CQM, Six Sigma Black Belt preferred. • ASQ Certified Quality Manager (CQM), Certified Quality Engineer (CQE), or Certified Auditor credentials (e.g., ISO 13485). • Lean and or Six Sigma Certification. • Previous experience in Quality engineering and commercialization process with drug delivery devices and combination drug/device products is desired • Design assurance experience in the design and manufacturing scale-up of injectable devices (e.g. auto-injectors, pens, needle-free injectors, syringes) or devices for non-invasive or minimally invasive drug delivery systems (e.g. pulmonary, transdermal). • Familiar with PCB/PCA assembly and fabrication. • Strong background with requirements management, configurations management, defect tracking, and requirements tracing tools • Advanced problem-solving, risk assessment, statistical analysis, and negotiation skills expected. • Experience with complex, cross-functional development projects. • Experience working with and leading cross-cultural teams. • Proven ability to apply situational leadership concepts across various intra and inter-departmental matters. • Demonstrated time management, decision making, presentation and organization skills. • Ability to converse technically with mechanical, electronic, software, clinical, regulatory, and quality engineering disciplines.2012-05-09 20:34:27United StatesAmgenCalifornia14257BRCAThousand Oaks, CA28581281http://www.amgen.jobs/xml/28581281/jobUSABothellAuto req 13445BR Job Posting Title Product Quality Director Career Category Quality Employee Subgroup Salaried FT Country (State/Region) United States - California United States - Colorado United States - Puerto Rico United States - Rhode Island United States - Washington Location (City) Bothell Boulder Field Based Juncos Lake Centre Longmont Seattle Thousand Oaks West Greenwich Amgen Job Description The successful candidate will become a Product Quality Leader (PQL). The individual will provide technical expertise and project leadership to the relevant Product Quality Team(s) to develop, implement, and manage strategy for Quality to meet the Global Operations Teams (GOT) and product goals for Amgen products. As a product expert in Quality, the Product Quality Leader has responsibility for working directly with other PQLs, Global Operations Leader (GOLs), International Expansion (IE), Corporate Quality Control (QC), site QC, Regulatory, Process Development (PD), Quality Assurance (QA) etc. on the resolution of issues associated with process/manufacturing, In-Process Control (IPC), analytical methods, specifications, reference standards, importation testing, investigations, change control, regulatory submissions, international expansion and inspections related to Amgen product(s). The individual will be directly responsible for Product Quality related tasks in support of Amgen’s late-stage clinical and commercial products. These tasks include but are not limited to; ownership, authoring and review of documents, and execution of transactions in relevant GMP systems (change control, etc.). In addition to these responsibilities, the candidate will be expected to play a role in supporting other product quality issues and initiatives intended to ensure the overall product health. This position can reside at Amgen sites in Thousand Oaks, CA, CO, RI or Puerto Rico. Basic Qualifications ? Doctorate degree & 4 years of directly related experience OR ? Master’s degree & 8 years of directly related experience OR ? Bachelor’s degree & 10 years of directly related experience Preferred Qualifications B.S. in biochemistry, biology, or a related protein/biotechnology sciences field 10 + years of biopharmaceutical experience with increasing responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment, OR - an Advanced degree in biochemistry, biology, or a related protein/biotechnology sciences field and 7 + years of biopharmaceutical experience with increasing responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment experience. - 10+ years working in a regulated environment (either direct GMP or technical support) - 4 + years experience with authoring or review of biological license applications, IND, supplements or similar regulatory documentation. - 4 + years experience supporting non-conformance investigations, authoring, reviewing and defending critical product impacting non-conformances - Experience in Project Management in support of biopharmaceutical development There is a strong preference for candidates who are familiar with compliance and regulatory requirements of the FDA as well as international regulatory agencies in international expansion regions. Prior experience in direct interaction with regulatory agencies during inspections or meetings is helpful. Knowledge of analytical techniques used for biologics product quality control. Understanding of biopharmaceutical bulk and drug product development and manufacturing. Familiarity with Bispecific T cell Engager (BiTE) antibody technology. In-depth knowledge of cGMP and filing regulations, practices, and trends pertaining to the manufacture and testing of biopharmaceuticals. Previous experience working on a cross-functional team in a matrix environment. Excellent written and verbal communication skills, including facilitation and presentation skills.2012-04-05 19:44:51United StatesAmgenCalifornia13445BRCABothell, CA27668144http://www.amgen.jobs/xml/27668144/jobNLDBredaAuto req 13960BR Job Posting Title Specialist QA Career Category Quality Employee Subgroup Salaried FT Country (State/Region) The Netherlands Location (City) Breda Amgen Job Description Objectives Provides the QA oversight review and approval of validation strategies and documents Provides QA oversight review and approval of Packaging Engineering strategies and documents Position Specific Tasks Operational - Provide guidance for validation impact assessment for change control requests. Participate in ABR projects and improvement efforts. - Ensures that Quality policies, procedures and programs are properly implemented in daily Process Development operations and remain in compliance - Provide coaching, guidance and compliance direction to Facilities, Engineering , Maintenance and Process Development. - Work with other disciplines in developing requirements and strategies for large and/or highly complex process, system and facility modifications. - Develop solutions to complex validation problems requiring the use of ingenuity and creativity while maintaining compliant. - Work with project managers to complete the validation responsibilities of projects within schedule, budget and quality constraints. - Provide Quality oversight and approval for process development, engineering, validation projects and validation deliverables - Provide Quality oversight for good engineering practice documentation and system development. Process Maintenance: - Ensure Validation process at the site is maintained according to Corporate and GMP requirements and procedures reflecting process are in place and effective. - Integrate advanced validation engineering techniques ensuring alignment with industry standards. - Develop and provide Validation Training - Act as Validation contact in corporate and regulatory inspections, as needed. Basic Qualifications Minimum Requirements - Bachelor’s degree in Life Sciences or Engineering field or equivalent. - Typically 5+ years of related professional experience. OR - Master’s degree in Life Sciences or Engineering field or equivalent. - Typically 3+ years of related professional experience. OR - PhD in Life Sciences or Engineering field or equivalent. - Typically 1+ years of related professional experience. - Fluent in English. - Direct experience with regulated environment required. - Strong knowledge of GAMP, ASTM E2500, Annex 13, ICH Q7A, CFR 11, 210 and 211. Preferred Qualifications Preferred Requirements - Typically 10+ years of related industry experience in anufacturing and/or Quality Assurance. Strong knowledge of Good Distribution Practices.2012-02-16 21:59:39NetherlandsAmgenNone13960BRNoneBreda, NLD26576301http://www.amgen.jobs/xml/26576301/jobUSALongmontAuto req 13452BR Job Posting Title Dir EH&S Career Category Quality Employee Subgroup Salaried FT Country (State/Region) United States - Colorado Location (City) Longmont Amgen Job Description Job Summary: An experienced Environment, Health & Safety Director (EHS) to provides vision and strategy for site and/or global EHS initiatives. Responsible for keeping site senior management informed on the status of environment, safety and health matters affecting the site. Assists Site Quality Executive Director in formulating and executing company practices as they related to environment, safety and health performance. Delivers results through influence and communicating effectively with clients and practical integration of EHS with business practices. Independently take actions to drive improvement in EHS performance and practices. Manage complex problems and coordinate the implementation of innovative solutions. Functions (Duties/Accountabilities): EHS Management: Develop a management system which ensures that EHS is a key component of all site activities. Applies practical environment, safety, and health operating standards to ensure continuous improvement in EHS performance at the site. Influence line management to ensure that EHS is managed by line management as a core skill. Implement CAPA program to ensure actions are taken in a timely manner for effective close out of all findings from incidents, risk assessments, inspections and audits. Incident management: Incident investigation and root cause analysis, reducing potentially serious incidents, injuries, environmental incidents, case management and injury prevention programs Risk Management: Risk assessment for various aspects of EHS and capable of implementing a program at all levels of the facility. Knowledge and experience of process hazard evaluation techniques such as What If, HAZOP, FMEA. Safety culture programs: Develop and implement Amgen safety culture program to integrate EHS as part of the day to day operations. Ensure early reporting by staff of unsafe conditions and behavior and near misses. Project design review: Implement process for carrying out EHS review of projects, a management of change process, and handover and commissioning processes. Contractor safety management: Ensure contractors comply with Amgen EHS requirements. EHS Program Compliance: Provide technical guidance for the implementation of Amgen’s Environment, Industrial Hygiene, Occupational Health and Safety programs to ensure compliance. Engineering safety: Permit to work, Lock out tag out, confined space entry, cranes and hoist Personal Protective Equipment: - Managing hazardous substances including flammable and combustible materials, biologics, regulated carcinogens and controlled substances - Employee exposure determinations - Ergonomic design and assessment - Fire and life safety - Waste management - Air and waste water permitting and compliance Process safety management: Oversee management of chemical inventory and waste management programs (chemical, biohazard, radiation, universal, etc.). Regulations: Implement systems to ensure compliance with applicable EHS regulations. Evaluate existing and new regulations’ impact upon Amgen operations. Develops new programs and implement changes as necessary. Training: Implement EHS training strategy for Amgen staff & contractors and develop new training programs as required. Environmental Sustainability: Implement programs to ensure accurate data is collected for the sites environmental impact and to reduce the ongoing environmental impact of the site’s operations. Internal Auditing: Communicate audit results to site senior management. Review findings for trends and/or improvement opportunities that affect the site. Supervision: Managing staff and/or technical personnel in multi-tiered organization. Basic Qualifications Doctorate degree and 4 years of directly related experience OR Master’s degree and 8 years of directly related years OR Bachelor’s degree and 10 years of directly related experience AND 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications MS Degree environmental, safety, industrial hygiene, technical, scientific or engineering 12 or more years of experience developing and implementing EHS programs in a biotechnology/pharmaceutical company Experience in implementing an EHS management system (OHSAS 18000, ISO 14000). 7 years of supervisory experience Knowledge with European regulations as they pertain to pharma/ biotech operations Applied knowledge and understanding of EHS principles and practices, regulatory standards, and requirements in context of business activities. Postgraduate professional qualification preferred (e.g. Certified safety practitioner (CSP)) Leadership, team building, strong communication skills, action oriented, self starting, program development and project management. Proficient in Microsoft Office and other computer software systems. Good technical & business writing skills and team skills.2012-01-26 22:26:16United StatesAmgenColorado13452BRCOLongmont, CO26140230http://www.amgen.jobs/xml/26140230/job