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This is Harry from Dynamic Enterprise Solutions. We have urgent requirement with one of our client's, please review below job description and let me know your interest Request ID: DESFK0001859-1 Title: SQA / MQA Specialist (software Quality Analyst) Location: Boston, MA Duration: 6 Months+ Locals Only (Direct onsite work) Job Description: Primary MQA Specialist II duties to be performed by the contractor will include performing QA label review, batch record review, line clearance verifications, shipment data reviews and logbook reviews. POSITION SUMMARY Responsible for quality assurance activities/decision making associated with cGMP manufacturing, investigations, change control, complaint investigations and documentation. Ensures that proper controls are instituted and maintained during the manufacturing, processing, packaging and warehousing of compounded product. PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT. . . Support implementation of Master Batch Records and associated manufacturing and Quality related systems for the compounding processes. . . Ensure day-to-day compliance to all requirements established for compounded product and the systems supporting compounding. . . Support problem identification and resolution efforts for quality related issues associated with the compounding operations. . . Ensure appropriate investigation and closure of incidents, change controls, and complaint investigations; direct implementation of appropriate solutions. . . Review and approve manufacturing batch records, QC testing, SOPs and other batch related documentation. . . Assist with internal, corporate, 3rd party and federal/state inspections and audits. . . Provide reports on measures of local quality system effectiveness such as right the first time, documentation errors and others as assigned. . . Represent QA for Product manufacturing and Media Fill execution. . . Ensure cGMP documentation associated with work activities is complete. . . Maintain assigned standard operating procedures. . . Assist in the disposition of incoming material and final product. . . Performs other related duties as assigned. REQUIREMENTS . Bachelors degree in a scientific discipline and at least three years of relevant Quality Assurance experience in a pharmaceutical manufacturing company. . Experience with aseptic technique, statistical sampling (ANSI Z1.4 Sampling Plan) and Trackwise preferred . Excellent problem solving skills . Ability to work in a fast paced environment . Ability to handle a high volume of work and rapidly adapt to changing environment . Preferred skills include root cause analysis and six sigma methodology training Position ID: DYES00011644 Title: Sr. Information Security Analyst Duration: 12 months+ Location: North Chicago, IL Duties: . Attend/assist in coordination of meetings with supplier and client relationship owner(s) . Tracking/monitoring of remediation efforts . Engages with client business and Third Party Suppliers to assess security posture, remediation requirements, assess documentation and evidence and compensating controls as they apply to control gaps identified during the third party supplier evaluation assessment. . Review/approve evidence of how security gaps have been remediated by the supplier . Evaluates and articulates supplier information security requirements; Review supplier evidence/answers to Third Party Evaluations . Provides information security expertise and guidance to business owners to ensure an appropriate understanding of information security risks as this will enable business owners to have an understanding of their supplier risks and make a risk base/informed decision. . Train on client Information Security policies, processes and procedures, as well as compliance processes and initiatives in order to provide subject matter expertise and guidance to business owners within Experience level: . Sr. Information Security Analyst with good IT supplier information security knowledge, we can provide some training to get the candidate up to speed. Need to make sure the candidate has at least the educational background and or certifications on IT information security. . Encryption Knowledge, Systems Support/Server Admin experience, Identify Access Management, and Third Party Evaluation process. Qualifications: Bachelor's Degree with 6 years of total experience or Master's degree with 5 years of experience Remote work: Yes, candidate can work remotely within the US only Must have: . Overall security knowledge, specifically in Encryption tools and techniques, Systems Support/Server Admin experience, Identify Access Management, and Third Party Evaluation process . Able to evaluate and articulate supplier information security requirements; Review supplier evidence/answers to Third Party Evaluations and provide information security expertise and guidance to business owners to ensure appropriate understanding of information security risks . Able to work across the different business units/functions at all levels of the organization. The candidate will be attending/assisting meetings with business owners, sr. management and suppliers to understand risk, remediation activities, and effectiveness of remediation plans against our security controls in an effort to close open security issues/gaps. Demonstrated skills in project management, collaboration, communication and organizational skills Nice to have: . CISA and/or CISSP experience/certifications . Mix of IT operations and business programs Position ID: DYES00011631 Title: Project Manager - Quality Assurance BTS (Operations BTS Quality Systems) Length of Contract: 2 years Location: Madison, NJ Locals Only Job Description: . Coordinates and monitors the scheduling, pricing, and technical performance of key BTS QA projects. . Responsibilities may also include aiding in the negotiation of contracts and contractual changes and coordinating preparations of proposals, plans, specifications, and financial conditions of contracts. . Ensures adherence to master plans and schedules, develops solutions to program problems, and directs work of incumbents assigned to program from various departments. . Ensures projects are completed on time and within budget. Acts as advisor to project team regarding project financials, tasks, and operations. . Prior work experience in an IT delivery function and/or a health and life science organization greatly preferred . Experience managing large, cross functional projects required . Strong written and verbal communication required . Experience managing large complex IT Pharma projects driving key business level goals and deliverables . Experience in Microsoft Applications (PPT, Excel, Word, Project, etc.) required . Requires a bachelor's degree and at least 8+ years of experience in the field or in a related area. PMP and ITIL certifications nice to have but not required . Standard work schedule - some overtime may be required during projects . Role is managing projects and project team members with dotted line reporting . Initially will require 5 days onsite. Can be a little flexible if there is a strong candidate after initial ramp up period Number of technologies used - Familiar with Biopharma Quality solutions, Clarity, and SAP as well as large scale IT programs preferred. Scope of the project - primarily Project management level Presentations required to mid to upper level management. - Nice to have PMP but not required - more past experience is preferred. - Knowledge of Waterfall and AGILE is preferred - Change management experience would be helpful - Global Projects - most will have a global reach. Description Details * Are you open to look at candidates willing to relocate? Yes * Years of experience/education and/or certifcations required: Requires a bachelor's degree and at least 8+ years of experience in the field or in a related area. * What are the top 3-5 skills requirements should this person have? a. Proven track record of delivering large cross functional projects. b. Relevant bio pharma and/or procurement experience (one or both) c. Proactive/strong communication d. Able to handle manage multiple projects in parallel * What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification? PMP and ITIL certifications nice to have but not required * What type of environment is this person working in? Group but able to work independently * Work Schedule (Define days,# of hours)/ Is Overtime offered or required? If yes, how many hours, what impact to scheduled working hours? Monday - Friday 8am - 5pm but flexible . Does this position offer the ability to work remotely on a regular basis or is it an on-site role? If remote opportunity exists, what are the options (i.e. 1 day remote, 4 days on-site)? Onsite * Is the worker onshore or offshore? Onshore * Will there be Domestic and/or International Travel? If yes, list proposed countries and % of time travelling: No Thanks & Regard's Harry John Dynamic Enterprise Solutions Inc 1801 Hicks Rd, unit A Rolling Meadows, IL -60008 (847) 719-7902 /C 224-635-0898 Email: [email protected] -- You received this message because you are subscribed to "rtc-linux". Membership options at http://groups.google.com/group/rtc-linux . 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