(US-New Hampshire) Our client, a proven leader in the single-use medical device manufacturing industry, distributes its’ high-quality products to world-wide medical facilities, is in need of a Senior Quality Assurance Engineer. The Senior Quality Assurance Engineers’ primary responsibility is to implement quality systems improvements. Quality assurance programs will be directly impacted by reviewing, recommending, and employing appropriate sampling plans and inspection techniques. RESPONSIBILITIES: *Preparation and analysis of ECO’s for quality system changes *Investigate, recommend, and implement changes to the established quality-sampling plan *Participate on Quality Improvement Teams, proposing effective product quality enhancements *Monitor and report unacceptable quality *Lead problem-solving teams to determine root cause and effective corrective action *Work with Quality Engineers to resolve supplier issues and chronic manufacturing quality issues *Provide guidance as necessary to QA Technicians *Interact with Design and Engineering Departments to investigate product failures EDUCATION/EXPERIENCE: *Minimum four-year degree in a science and seven years’ quality engineering experience in a medical device manufacturing environment *Knowledge of inspection methods, sampling plans, statistical analysis, and Statistical Process Control (SPC) *Experience with ISO9000/EN46000 and ISO14000 preferred *Training provided on current standards of ISO 9001, EN46001, and ISO14001 requirements Competitive salary + benefits.
(US-California-Ventura County) Research Scientist II -Functional Genomics Requirements: Ph.D. or the equivalent in Life Sciences, Physical Sciences, or Statistics/Mathematics. Previous experience in the analysis of microarray data strongly preferred, with particular emphasis on the development/implementation of statistical parameters and error modeling. Programming skills and/or familiarity with software packages such as SAS, MatLab, and Partek desired. An understanding of both two-dye and Affymetrix platforms desirable, as well as familiarity with Rosetta Resolver. Candidates should demonstrate the ability to motivate, lead, and/or supervise the activities of others, develop realistic timelines, and be able to problem solve using the application of scientific theory. Candidates should also demonstrate skills in independently determining and developing scientific analysis and solutions, as well as exercising considerable latitude in determining objectives of scientific work, and demonstrating strong project management skills. Creative skills in the development of new hypotheses for scientific experiments, in addition to critical evaluation and detailed interpretation of results, and a demonstrated knowledge of scientific relevance of targeted work is also required, as well as effective communication skills. Job Summary: This position's primary responsibilities include independently designing, implementing, and advancing analysis of microarray/high-content platform data within the Functional Genomics Group of Amgen. Specific responsibilities include supervising scientific projects, defining project goals, proactively defining experiments and critical evaluation of data with the integration of appropriate analytical/statistical models in these analyses. Employees will provide critical evaluation of scientific data and results, as well as provide technical mentoring and expertise to RSI level staff, and participate in, and contribute to, various key or critical teams. Additional responsibilities may involve participating in new product/research opportunities, advising supervisors and colleagues in areas of expertise, and investigating possible external opportunities and participating in the development of external contacts and collaborations. Employees will also assist in Licensing in evaluating opportunities, in addition to expanding technical areas of expertise to a broader level of understanding in relevant scientific fields. This position is also responsible for organizational efficiency through participating in recruiting and candidate evaluation, and seeking out and analyzing competitive scientific knowledge from external sources. Amgen’s outstanding compensation package features comprehensive benefits and relocation assistance.
(US-California-Ventura County) GLP Compliance Advisor III Requirements: A minimum of four (4) years of experience in a regulated environment is required along with 2 years of related computer system validation and/or quality assurance experience. The candidate must be able to routinely handle multiple tasks and be timeline driven. The candidate will possess the ability to work independently and within teams; strong written, oral, and organizational skills; and excellent attention to detail. The candidate should also possess detailed knowledge of the software development life cycle, 21 CFR Part 11, and IT processes. A working knowledge of the GLP regulations and preclinical development processes are preferred. Candidates should possess an undergraduate degree in the physical or computer sciences. Job Summary: Provide GLP quality assurance oversight, with emphasis in the area of computerized system validation and electronic record handling. Communicate the compliance requirements associated with computer systems and electronic records and signatures to appropriate management and client departments. Conduct inspections and audits to assure management that associated documentation is accurate, and complete; follows approved methodology and protocols, and adheres to all applicable SOPs and regulatory requirements. Perform process and facility inspections to assure management that electronic record handling and security measures are adequate to assure compliance with GLP regulatory requirements; and assess other activities such as system acquisition, vendor assessment, change control, and system retirement for proper documentation and adherence to approved methodologies, SOPs, and applicable regulations. Prepare written reports of inspection observations, review of corrective actions and provide Quality Assurance Statements for systems assessed. As assigned by management, assist in the evaluation and monitoring of contract laboratories in support of GLP studies to ensure compliance with Good Laboratory (GLP) regulations. Minimal travel (20%) may be required. Amgen’s outstanding compensation package features comprehensive benefits and relocation assistance. Come be a part of the big picture at Amgen.
(US-Wisconsin-Madison) Our client, a mid-sized biotechnology company, has an immediate need for a Manufacturing Compliance Specialist to oversee third party pharmaceutical manufacturing activities and ensure cGMP and regulatory compliance. This position is also responsible for compiling batch records, assisting in scheduling production and transportation of products and facilitate contract and project documentation. REQUIREMENTS: *Bachelor's Degree in Biology, Chemistry or Engineering *4+ years of hands-on experience in pharmaceutical production *Working knowledge of solid dosage, API and filled injectable product manufacturing and packaging *Working knowledge of clean room environment, sterile water systems, equipment and process validation, product review and nonconformance procedures *Working knowledge of GMP, GCP, GLP, and 21 CFR Part 11, Q7A and related ICH guidelines *Strong oral/written communication, organizational, project management and problem solving skills Relocation assistance & competitive salary.
(US-New Jersey) The ideal candidate for this position will develop, implement and document statistics objectives that meet the goals set by the Senior Director, Biostatistics. S/he will also evaluate and recommend statistical procedures and software for use within the Biostatistics department, and manage departmental statistical activities, including writing SOPs, writing work instructions for performing statistical activities, training users on these activities, and establishing and prioritizing time lines and tasks for statistics deliverables. Additionally this person develop, implement and document statistical activities that meet the overall statistics strategy, including standardized sections of protocols and reports, a standardized statistical analysis plan, standardized shells for tables, figures and listings, a standardized database structure and standardized programs (including SAS macros) that meet the specifications of the FDA and other regulatory agencies. The candidate will provide supervision, technical guidance and mentoring to statisticians and manage and/or perform study related statistical activities, using standardized programs where possible S/he will prepare, QC, document, maintain and archive statistical procedures and programs and review development plans. The ideal candidate for this role will estimate sample sizes for studies, determine appropriate statistical procedures, write statistics sections of protocol, review protocol, write statistical analysis plan, and co-write/review report and publications, maintaining consistency within a project and, where possible, across projects, and review study materials (e.g., CRF, monitoring conventions, data base specifications, edit checks) for conformance with protocol, standardized data base structure and standardized programs. S/he will write or review specifications for creating analysis datasets from raw datasets. This position assesses data integrity and validity of data, including review of edit checks and writes or reviews protocol deviations specifications. The candidate will perform planned and ad hoc statistical analyses and review and approve results presented in tables, figures and listings and conclusions for reports, labeling, publications and review SAS output (tables, figures and listings), data sets and programs for submission to regulatory agencies. S/he will represent statistics at regulatory meetings. QUALIFICATIONS The ideal candidate will have Ph.D. and at least 2 years of relevant experience, MS and at least 10 years of relevant experience, or BS and at least 15 years of relevant experience, and CNS Experience is favored. COMPENSATION Compensation includes a competitive base salary between $80-$105K DOE, and a comprehensive, flexible benefits package. Relocation is available for this position.
(US-California) QUALITY ASSURANCE DIRECTOR, Irvine, CA, for our client a full service clinical research organization, serving the pharmaceutical, biotechnology, and medical device companies. POSITION DESCRIPTION The Director will lead the company’s quality operation and will be the first-line contact with all regulatory agencies. Additional responsibilities will include GCP training, regulatory compliance, facilitation of sponsor and regulatory audits/inspections. S/he will provide guidance to the executive leadership in assurance of corporate compliance and meet the industry’s best practices. The Director of Quality Assurance will lead, mentor, and train a team of QA auditors and drive the company’s quality initiatives. QUALIFICATIONS The ideal candidate will have a BA/BS degree complemented with a minimum of 10 years experience in quality operations, pharmaceutical quality assurance, auditing, and/or pharmaceutical regulatory services. Strong analytical and organizational skills are required to be successful in this role. This is an Irvine based position and will require a minimum of 25 percent travel. COMPENSATION Compensation is competitive and includes a base salary of $80K-$100K, a comprehensive benefits package, a generous time off program, and much more. Relocation may be a possibility, but a local candidate is preferred.
(US-California-San Francisco) In this key role, the ideal candidate will serve as the head/deputy head of the local Biostatistics department ensuring that target productivity (FTE, utilization, and output) levels are met. S/he will manage an assigned group of high-level staff/management from the Biostatistics, Statistical Programming, and RDQC sections and has direct personnel reports typically consisting of Supervisor - Associate Director level staff from each function. S/he will manage a group as large as 12 individuals. This individual will participate in sales meetings as required and will also oversee departmental proposal preparation. S/he will monitor the budgets and scope of office projects and will take action necessary to maximize realization. S/he will ensure that departmental staff contributes to intra- and interdepartmental process improvement to achieve "best practices". This individual will ensures that appropriate levels of professional development and training are provided to staff. S/he will serve as a biostatistical resource for the department, ensuring scientific integrity in the application of statistical methodology to Phase II-III clinical trials. The ideal candidate will provide statistical direction, technical oversight, or consultancy on major projects or on projects involving particularly complex statistical analyses. S/he will represent clients at FDA or other scientific meetings as required. QUALIFICATIONS Requires Ph.D. in biostatistics or statistics with 7 years of relevant experience, or Masters Degree in biostatistics or statistics with 10 years of relevant experience. A minimum of 4-5 years managing staff in a contract research or pharmaceutical industry setting is required. Familiarity with most complex statistical methods that apply to Phase II-III clinical trials and working knowledge of SAS. Excellent written and oral communication skills are required to be successful in this role. COMPENSATION Compensation is competitive and includes a base salary of $110K-$125K as well as a comprehensive benefits package. Relocation is available for this position.
