(US-California-San Francisco) This position is responsible for the development and validation of all microbiological methods and ensures the timely testing and release of finished products. The incumbent is also responsible for the development of microbiological procedures and systems for INDs, ANDAs, and NDAs. DEY is a specialty pharmaceutical company focused on the development, manufacturing and marketing of prescription drug products for the treatment of respiratory diseases (such as Chronic Obstructive Pulmonary Disease (COPD) and Asthma) and respiratory related Allergies (such as Anaphylaxis).
(US-California-Ventura County) Research Scientist III - Clinical Immunology Requirements: Ph.D.in Life Sciences is required. Must have extensive experience (5+) in development and validation of cell-based assays for analytical or bioanalytical purposes in a supervisory capacity. Prior industry experience in this role is preferred. Knowledge of regulatory compliance requirements for GLP in a development environment; knowledge of equipment validation and calibration; knowledge of computer systems for data and sample management is required. Knowledge of statistical tools for data analysis is preferred. The candidate should possess good verbal and written communication skills and good organizational skills. The candidate should demonstrate good leadership skills encompassing goal setting, performance and career management and resource allocation. Job Summary: This position's primary responsibility includes providing scientific direction to staff developing and validating serum-based bioassays for measurement of drug activity and detection of anti-drug neutralizing antibodies in biological samples. The candidate will establish goals for scientific projects, personnel, and other resources, provide intellectual insight into scientific data and results, and make significant contributions to evaluating new assay platforms. Additional responsibilities may include supervising or directing the work of other staff (i.e. Scientist I/II''s, Associate Scientists, Associates, and Laboratory Assistants). The candidate will also interface with cross-functional groups on product development teams and prepare relevant sections for regulatory submissions.
(US-Massachusetts-Boston South) Assemble and analyze monthly and quarterly corporate quality metrics. Includes compiling data submitted from sites and Corporate functions, identify and analyze data trends and clarify data integrity concerns. Generate/modify new/existing data forms as needed, to most effectively present quality metrics. Work on implementation process of Global Complaint System to facilitate compliance to appropriate quality standards and 21 CFR Part 11. Work on team to investigate, recommend and implement solution for global Corporate Corrective and Preventive Action System. Coordinate submission, entry and analysis of monthly and quarterly Quality metrics data for management reporting. Provide daily Corporate Compliance maintenance to the Corporate Corrective and Preventive Action System. Perform audits and assessments of divisional and corporate systems to determine compliance with QSR and 21CFR11 requirements. Work with Director of QA/IT Support to develop global plan to assess Part 11 compliance organizationally. Facilitate validation/revalidation efforts of existing corporate systems as needed. Provide guidelines for Master Validation Plans and Software Risk Analysis for global complaint solution and corrective and preventive action system. Work with Director of QA/IT Support to author Corporate SOPs/policies (incorporating existing structure/templates) including 21 CFR Part 11 requirements. Responsible for working with QA and IT teams on validations, protocol and process reviews, and implementation of requirements in compliance programs. This position requires excellent skills in communication, time management, in depth analysis (attention to detail), and project completion. Also requires skills in program/project management, program coordination, conducting requested assessments of particular software programs and/or processes as needed and in working with a wide variety of people. Strong skills in report and quality metrics generation and verification utilizing software tools (databases, Excel, Foxfire, Crystal Reports, HTML, etc). Strong understanding of SQA/SQE, validation and development principles desirable. Bachelor?s degree in computer/biological sciences or equivalent based on prior work experience. Minimum five years experience in QA/QE and/or software quality/engineering. Comprehensive working knowledge of FDA regulations and guidelines, QSR, and 21 CFR Part 11. Quality / Compliance auditing skills and training desirable. A minimum of three years experience in medical device industry or other regulated industry. Knowledge of SAP or other ERP system(s) desirable.
(US-Massachusetts) The QA Specialist, GCP Auditor will provide Clinical QA oversight and perform audits of pre-clinical and clinical sites. Responsibilities Include: Work with clinical group and regulatory affairs to ensure compliance in all phases of clinical work study Coordinate training of CRAs, both on-site and offsite Provide in-house training on GCPs Work closely with QA Management to conduct audits of ongoing clinical trials Requirements: BS in science/healthcare with 6-8 years experience in clinical or quality assurance and 3-4 years auditing experience Complete understanding of GCPs and in conducting quality audits, understanding of all phases of clinical trials Ability to ensure compliance with regulations and quality standards Prioritize and expedite multiple tasks Advanced computer skills in Microsoft Word, Excel and Access Strong communication skills and ability to write concise, accurate reports.
