Job Summary: (Part - Full Time): Support all the major functions assisting owner / CEO of a small regulatory, quality engineering and validation services company for the pharmaceutical / medical devices industries.
Rate: $10 - 18/hr
Location / Travel: Company is based in Irvine, CA. Up to 25% travel; rest of the work can be done from your desired location (home). Travel may be with CEO.
Job Functions / Accountabilities: 1. Record Keeping and File Management a) Maintains records and including agendas, minutes, correspondence, reports and other b) Personnel Files and Timesheets c) Service Contracts, Leases and Inventory of Assets d) Agency Advertising and Promotion / Special Events e) Incident Reports and summaries f) Program files 2. Reporting and Scheduling a) Monitors deadlines to maintain systems of accountability and reporting . b) Manages travel arrangements for the Executive Director c) Compiles financial expense reports 3. Typing and Transcription a) Typing technical procedures b) Editing and correcting reports and procedures for grammar, spelling, context, and technical content. 4. Database / Presentation Management a) Creates / updates / adds / edits dBases - Access & Act 5. Communications a) Responds to information requests b) Creates correspondences 6. Legal a) Writing, revising, editing contract agreements. 7. Research a) Internet and technology / industry search for data. 8. Marketing a) ·Find and initiate contact with clients b) Create good report with clients. c) Analyze the effectiveness of all marketing campaigns and programs, including key lessons learned, and make recommendations to improve them. d) Will track client satisfaction and inform company on client's needs. e) Will promote business through low budget advertising, Internet means, and correspondence. f) Will be able to interpret market trends and use that information to tap into potential client pools.
Job Requirements: Excellent PC skills and fast typing skills. Excellent grasp of the English Language. Self-motivated, quick learner, industrious, trustworthy, technically savvy, and reliable. Demonstrated excellent decision-making and organizational skills. Excellent verbal and written communication skills with management and peers. Efficient at: 1. Technical Writing (knowledge of legal / technical language) 2. MS Office (Word, Excel, Access, Outlook, PowerPoint) 3. Internet Research 4. Technical / Protocol / Procedure writing (will train) 5. Some knowledge of small business law and/or contractor law.
(Desired / Not Essential will train): Knowledge of: 1. MS Project 2. Web design basics. 3. Web publishing using FTP format and/or FP2000 4. Pharmaceutical / Medical devices / IVD industry Quality / Regulatory requirements 5. FDA, OSHA, and/or DEA regulations 6. ISO 9000's, 21CFR parts 820/211 (cGMP's/QSR), and Part 11 (ERES) 7. Auditing of facilities and records for GMP/QSR and Part 11. 8. USP (United States Pharmacopoeia) 9. Validation Engineering 10. Validation & Verification of Software driven medical devices. 11. Industrial Chemistry / Microbiology / Environmental Monitoring testing 12. Quality Engineering / Quality Control / Quality Assurance Principles 13. ACT 14. Access 15 Basic Statistics
Job Summary: (Part - Full Time): To lead the software validation and verification effort for the Quality Systems and Operation Department to ensure that company objectives are obtained for business software implementations. This includes interfacing with the clients for the prospective software, directing the documentation of software requirements specifications, structural / functional validation plan and protocol development, and software validation. This position has the ultimate responsibility for ensuring compliance with FDA, ISO and corporate standards and guidelines with respect to all required documentation when validating a computerized business system.
Rate: $15 - 38 /hr
Location / Travel: Company is based in Irvine, CA. Up to 25% travel. Rest of the work can be done from your desired location (home). Travel may be with CEO.
Job Functions / Accountabilities: 1. Responsible for the integrity and acceptable performance of all in-house computerized systems assigned for implementation, major upgrade, or enhancement utilizing widely recognized software validation strategies common to the industry. 2. Direct responsibility for business software / computerized systems validation activities and compliance with all GMP and corporate standards / guidelines. 3. Accountable for the completeness, accuracy, and testability of all necessary software validation documentation and associated test cases. Direct and train Project Team Members on strategies of how to compose legitimate and executable test cases. 4. Ability to employ systematic software testing methodology based on the understanding of the software development cycle. Recognize a testable requirements specification, and subsequently create effective test plans and documents. 5. Provide innovation to improve the Operations software validation process by making available tools / guidance / training for applying software validation techniques to common business practices. 6. Research and communicate new FDA and corporate software validation regulations to Project Implementation Team and / or appropriate employees. 7. Keep abreast of new developments in software validation and verification strategies and associated tools. 8. Other responsibilities as defined by the CEO / Owner.
Job Requirements: 1. Minimum of 2 years of college in a technical field. 2. Computer / ICS majors or other majors with extensive knowledge of computer systems and network infrastructure. Excellent PC skills. 3. Self-motivated, quick learner, industrious, trustworthy, technically savvy, and reliable. 4. Demonstrated excellent decision-making and organizational skills. 5. Excellent verbal and written communication skills with management and peers.
Other Job Requirements (Desired / Not Essential will train): 1. Experience / Knowledge of software V&V experience with background in medical device manufacturing. 2. Experience in new product implementation. 3. Basic knowledge of the manufacturing / operation process. Familiarity with integrated ERP systems. 4. Knowledge of GMP, ISO, and other regulatory procedures, policies, and guidelines.
Job Summary: (Part time): Will update and/or develop websites. Will use own or supplied tools to develop sites for a small regulatory, quality engineering and validation services company for the pharmaceutical / medical devices industries. Websites will vary in the type of services / product provided. Websites will vary in the type of technology used. Some will be information only and some will require user interactivity. Support development of E-Commerce.
Rate: $12 - 38 /hr (or netted per project)
Location / Travel: Company is based in Irvine, CA. Up to 5% travel. Rest of the work can be done from your desired location (home).
Job Functions / Accountabilities: Develop / maintain existing websites. Debug sites and maintain links. Enhance / Improve Search Engine ranking. Create Information Only, Interactive and E-commerce sites.
Job Requirements: 1. Minimum of 2 years of college in a technical field preferably ICS / Computer Sciences. 2. Self-motivated, quick learner, industrious, trustworthy, technically savvy, and reliable. 3. Demonstrated excellent decision-making and organizational skills. Required Knowledge: 1. FTP/HTTP and web publishing basics. 2. Understands technologies such as SSL, SSI, ASP, PHP, CGI, etc. 3. Understands how to manage webmail (POP/SMTP). 4. META tags, spidering technology, search engine, marketing and submission principles. 5. DNS and domain registration practices. Knows how to work with InterNIC. 6. Knowledge of NT server requirements and (optional) Unix / Linux servers.
Other Job Requirements (Desired / Not Essential will train): Knowledge: Design Tools / Applications: FP2000, DreamWeaver / other Macromedia Tools, Adobe GoLive, ColdFusion, etc. Programming: ASP, SQL, JAVA, Perl, CGI scripts, Java Sprites, Java Applets Databases: Access, SQL, and ACT. Graphics: Flash, Photoshop, Corel, etc.
Job Summary: (Part - Full Time): In this position, you will provide technical support for the equipment, computer, automation systems, cleaning, test method, and facility validation, per GMP requirements. You will support validation projects as part of a project team and will provide assistance with the development, execution and completion of computer validations in accordance with FDA 21CFR guidelines and client expectations. Provide Quality Assurance oversight for GMP, GLP, and GCP. Review and approve validation documentation for manufacturing automation and information systems (e.g. PLCs, DCS, MES); quality information systems (e.g., LIMS, EDMS); and GCP/GLP information systems (e.g., data reduction programs, sample tracking, and adverse event reporting). Perform quality analysis of new technologies, provide input for system development, testing and maintenance. Consult on the preparation and execution of system development and validation documentation.
Rate: $14 - 38/hr
Location / Travel: Company is based in Irvine, CA. 50% of the work can be done from your desired location (home). Up to 50% travel: travel may be with CEO.
Job Functions / Accountabilities: * Writing / typing of Procedures / Protocols and Reports. * Analyze and apply technical drawings, CAD's, schematics, blue-prints, ladder logic, logic flow charts, layouts, and other. * Apply tolerances and/or evaluate protocols / reports for tolerance accuracy. * Check, evaluate, and verify procedures, protocols and reports for technical validity, application of proper gov't std's, and industry std's. * Evaluate data and apply statistics / interpret. * Apply sampling frequency, accept/reject sampling, and other stats based on mil. std's and statistics to protocols. * Create, follow, and verify Test Matrix for accuracy. * Create templates
Job Requirements: * Excellent PC skills. Excellent grasp of the English Language. 1. Minimum of 2 years of college in a technical field. 2. Life Sciences, Math Sciences, Chemical, Mechanical, Software, Computer, or Industrial Engineering majors preferred. 3. Self-motivated, quick learner, industrious, trustworthy, technically savvy, and reliable. 4. Demonstrated excellent decision-making and organizational skills. 5. Excellent verbal and written communication skills with management and peers. Efficient at: 1. Technical Writing (knowledge of legal / technical language) 2. MS Office (Word, Excel, and other common office tools). 3. Technical / Protocol / Procedure writing. 4. Technical Editing with an eye for tolerances, software logic, CAD & Schematics / Drawing Detail. 5. Basic Statistics
(Desired / Not Essential will train): Knowledge of: 1. MS Project 2. Pharmaceutical / Medical devices / IVD industry Quality / Regulatory requirements 3. FDA, OSHA, and/or DEA regulations 4. ISO 9000's, 21CFR parts 820/211 (cGMP's/QSR), and Part 11 (ERES) 5. Auditing of facilities and records for GMP/QSR and Part 11. 6. USP (United States Pharmacopoeia) 7. Validation Engineering 8. Validation & Verification of Software driven medical devices. 9. Industrial Chemistry / Microbiology / Environmental Monitoring testing 10. Quality Engineering / Quality Control / Quality Assurance Principles. 11. Failure Modes and Effects, Fault Tree Analysis, and Hazards Analysis. 12. Corrective Action and Preventive Action methods 13. Clean Room Operations and requirements. 14. Industrial Safety. 15. Vendor Audits and Qualification Process.
Job Summary: (Part time): Will be responsible for finding new clients in the Biotech, Pharmaceutical, Medical Devices, IVD, and other industries. Will seek, create contact, and introduce our service to potential clients. Will track client satisfaction and inform company on client's needs. Marketer must be highly competent on the phone, Internet, and fax to complete business transactions. Marketer will be well informed of the market, financial situations, and FDA warnings to enhance client-finding. Marketer will promote business through low budget advertising, Internet means, and correspondence. Marketer will be able to interpret market trends and use that information to tap into potential client pools.
Location / Travel: (Part time): Company is based in Irvine, CA. Up to 5% travel. Rest of the work can be done from your desired location (home).
Rate: $12-18/hr + 15% comission.
Job Functions / Accountabilities: * Enhance / Improve Search Engine ranking. * Find and initiate contact with clients. * Create good report with clients. * Analyze the effectiveness of all marketing campaigns and programs, including key lessons learned, and make recommendations to improve them. * Analyze market needs, industry dynamics and competitive business models to provide competitive intelligence to the company. ·* Work closely with the company to leverage service capabilities. ·* Develop the marketing strategy to drive new sales more efficiently and cost-effectively.
Job Requirements: * HIGHLY effective at NEGOTIATIONS, and INFLUENCIAL. * HIGHLY TACTFUL, ETHICAL, and Businesslike. * Aggressive Seeker. * Warm / Inviting voice and Eloquent speaker. * Knowledgeable of the service / technology being provided and the market needs. * Understanding of cultural, religious, and regional demographics and uses that info to best business advantage. * Understanding of Industry situations, company dynamics, and * Strategic Thinking skills * Excellent Internet search engine (and other searching tools) knowledge and use. * Excellent analytical and strategic skills, with ability to draw key business insights and present findings both verbally and in writing. * Demonstrated ability to communicate successfully with the executive-level across an enterprise. ·* Self-motivated, quick learner, industrious, trustworthy, technically savvy, and reliable. * Demonstrated excellent decision-making and organizational skills. * Excellent verbal and written communication skills.
Other Job Requirements (Desired / Not Essential will train): Knowledge: - Sales and sales techniques. - Computer use: Excel, ACT, Access and other database. - Knowledgeable about Quality Assurance/Control and Validation Technology. - Understanding of the Pharmaceutical and Medical Device Industry. - Knowledge of Manufacturing Industry: Chemistry, Microbiology, Toxicology, Nuclear, Environmental -Monitoring technology. - Knowledge of Software / Computer compliance Regulations (Part 11). - Understands the Manufacturing Process, Supply Chains, and ERP/MRP. - Understands the Documentation Management systems. - Knowledge of Confidentiality, Intellectual Property, and Contract/Consulting Laws.
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