San Diego Biotech Jobs
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Details: Purpose and Scope Responsible for the development and execution of validation activities including, design, installation, and operational qualification of equipment/utilities/facilities, process validation for all manufacturing processes, lab equipment qualification, and cleaning validation. Writes, executes, or reviews all of the above listed protocols and reports. Essential Duties & Responsibilities Develops validation strategies for complex validation projects. Develops and implements creative solutions to complex problems. Work with various departments to assign responsibility for protocol generation, execution, and review. Responsible for the change control system for all validated processes and equipment. Write and maintain site and special projects Master Validation Plans. Plans and coordinates the validation activities for projects. Work with Process Development, Engineering, and Maintenance in establishing equipment purchase requirements from the validation perspective. Responsible for the appropriate qualification of equipment, including its controls systems. Validate environmental controlled environments (warehouse, cold/hot chambers, etc), including product cold-chain transportation systems. Validate aseptic equipment (liquid and powder filling equipment, isolator, lyophilizer, autoclave, de-pyrogenation oven, Steam-In-Place, etc.). Validate cleaning processes (manual or automated). Validate manufacturing processes (liquid, semi-solid, solid bulks, filling, labeling, and packaging). Interface regularly with Engineering, Facilities, Regulatory, and Manufacturing personnel. Provide guidance and leadership over engineers who will write and execute protocols, but reporting into other managers.
Details: Job Description : Maintain and develop positive customer relations. (Main clients are Pharmaceutical companies and Academic Researchers.) Consult clients to understand their needs and customize product and service in order to meet clients’ needs. Develop, present, or respond to proposals for specific customer requirements Negotiate with clients and vendors regarding the service, products, price and contract. Estimate or quote prices, and collect payment from customers. Organize and prepare Exhibition for the company service / products Maintain open communications with other departments and business partner for smooth operation and better services for customers. Create Sales materials such as brochure and presentation materials. Generate and maintain customer list. Perform other duties assigned by the manager.
Details: Job Description: The Senior Safety Surveillance Associate is responsible for the processing of safety reports from clinical sites, spontaneous reporters, and other entities, as applicable, according to the Companys procedures and global drug safety regulations and guidelines. Serves as the Safety Lead for client study(ies)/project(s). Discusses safety project needs with client, performs project start up and close-out activities, and represents safety on the project team. Reviews and analyzes safety report information for completeness, accuracy and regulatory reportability requirements. Evaluates safety case data with an emphasis on medical presentation, conducts discussions regarding specific patient case data with health care practitioners, Sponsors, and business partners; determines regulatory reporting requirements based upon case data, product information, and FDA or ICH guidelines and regulations. Prepares safety reports, including preparation of narrative summary, and generation of reports for submission to Competent Authorities. Identifies missing/discrepant data (medical and documentation issues), writes queries, addresses queries with site personnel and/or reporter, evaluates query responses, and resolves queries when complete. Determines configuration specifications for the safety database, including updates. Performs coding of adverse event and medical history terms, concomitant medications, and laboratory test names within the safety database. Performs clinical review of data from the Case Report Forms with an emphasis on safety. Prepares safety information/tables and/or reports for clients and/or regulatory agencies. Reconciles safety data with applicable sources. May contribute to the development of internal processes, which integrates safety monitoring and processing of safety data with management of data in study specific clinical databases. Provides operational and technical guidance and direction to colleagues. Participates in audit preparation and conduct of audits. May present safety information to clients, deliver presentations at Investigator’s Meetings, and participate in meetings with potential clients. Provides operational and technical guidance and direction to colleagues; coaching and training to lower level personnel. DEGREE & EXPERIENCE Bachelors degree in nursing (B.S.N.), Registered Nurse (R.N.), Doctor of Pharmacy, Health Science degree or other related field of study and 5+ years safety surveillance experience or equivalent combination of education and experience. SPECIFIC KNOWLEDGE Extensive knowledge of medical terminology and of GCPs, ICH guidelines, and global drug safety and clinical trial regulations. SKILLS Intermediate level proficiency in Microsoft Word, Excel and Outlook; basic proficiency in PowerPoint. The ability to learn Safety database software and related software functionality. Effective verbal and writing skills; English + local language, if relevant. About Aerotek: Aerotek, headquartered in Hanover, Md., is a leading provider of technical, professional and industrial staffing services. Established in 1983, Aerotek is an operating company of Allegis Group, the largest provider of staffing services in the U.S. Aerotek operates a network of more than 200 non-franchised offices throughout the U.S., Canada and Europe. For more information, visit aerotek.com. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, genetic information or any other characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 844 895-8598 or email accommodation@aerotek .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.
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From Mettler Toledo – 20 Aug 2015 03:51:52 GMT
– View all San Diego jobs
Two Immediate positions are available at a Sorrento Valley biotech company for a Laboratory Technician.
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Leading biotech company has an immediate need for a Quality Assurance Asst to join their team.
This position is responsible for performing a wide variety of routine and semi-routine activities pertaining to assuring compliance with Quality Assurance […
Instructional Designer Opportunity (Healthcare/Biotech/Medical) – Clarity Consultants – La Jolla, CA
Experience Required 10+ years of instructional design experience Extensive experience in biotechnology industry, healthcare industry, biomedical industry…
From Dice – 20 Aug 2015 13:37:54 GMT
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Janssen Biotech, Inc. Very strong demonstrated leadership skills consistent with the J&J Leadership Imperatives (Connect / Shape / Deliver / Lead)….
From Johnson & Johnson Family of Companies – 20 Aug 2015 00:48:18 GMT
CA-San Diego, As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product’s value to payers, physicians and patients. A significant part of our business is acting as th