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2nd Shift, Monday- Thursday,  4 PM-2:30 AM Supervise the activities of the 2nd shift Visual Inspection operations. Provides support to 2nd shift manufacturing as needed. This position reports to the Manager, Kit Packaging Operations. Manage, together with the Visual Inspection Manager, the evening planning & scheduling activities for operations of the Kit Packaging activities including scheduling of personnel and monitoring of workload for daily operations (Saturday, Sunday, and Holiday operations if applicable) through the application of company safety, personnel policies and performance management. Support operations as needed and align schedules for one version of the truth in operators’ availability per production center. Writing and reviewing of investigational reports, SOPs, validation protocols/reports and the timely resolution and tracking of Quality Events (deviations, investigations, CAPAs). salary: $22 - $24 per hourshift: Secondwork hours: 4 PM - 2:30 AMeducation: High SchoolResponsibilities Proficient in Visual Inspection, Capmatic, Kitting and Pre-Kitting. The supervisor is tasked with keeping operations quality and compliance during 2nd shift Flexibility to change focus as needed. Interest in learning operations Good understanding of relevant metrics for Kit Packaging. Proven success in leading a team. Ability to escalate when required Actively promotes safety rules and awareness.  Demonstrates good safety practices at all times including the appropriate use of protective equipment.  Reports and takes initiative to correct safety & environmental hazards. Good understanding of cGMP. Must ensure GMP compliance in all operations Actively demonstrates the Lantheus values of “Help people be their best, “Respect on another and act as one”, “Learn, adapt and win”, Know someone’s health is in our hands”, “Own the solution and make it happen”. The essential functions of this role include:working up to 5 hrs of overtime per weekSkillsInspectionGMP (1 year of experience is required)Clean RoomPackagingQuality AssuranceSupervision (2 years of experience is required)Visual Inspection (1 year of experience is required)QualificationsYears of experience: 1 yearExperience level: ExperiencedRandstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad. Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

job summary: As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Our partner recognizes the need for innovative care and utilizes Research & Development to further knowledge in Oncology, Neuroscience, Rare Diseases, and Gastroenterology. As a company that brings in over $30 billion in annual revenue, they have established themselves as a biopharmaceutical powerhouse that is changing the world. If you're looking for a position where your work will benefit millions of people, we are waiting for you!   location: Lexington, Massachusetts job type: Contract salary: $162.94 - 191.70 per hour work hours: 9 to 5 education: Bachelors   responsibilities: We are seeking a highly motivated and qualified regulatory CMC professional for the Global Regulatory Affairs CMC & Device organization in the Plasma-Derived Therapies Business Unit. The Global Regulatory Affairs CMC & Device organization is responsible for global CMC regulatory strategies and activities (strategy & authoring) for the PDT BU product portfolio, market launch and product lifecycle management. The Strategist works in a highly matrixed, global product team-oriented environment and ensures close collaboration within the Global Regulatory Affairs CMC & Device organization and with other PDT BU functions and relevant company R&D functions to provide an effective and aligned regulatory CMC strategy and submission approach globally, regionally and locally The Strategist, Global Regulatory Affairs CMC, PDT BU is responsible for: Defining, coordinating and implementing global CMC regulatory strategies for product-specific development and life-cycle activitiesProviding proactive strategic guidance to the product-specific global regulatory and manufacturing sub-teams for defining global regulatory CMC strategies and objectives pertaining to the development, registration, commercialization and lifecycle management of the drug product in the United States and international markets.Manages the CMC regulatory strategy of high quality and compliant regulatory CMC documentation for the assigned product(s) within defined timelines as per R&D and business objectives.Advises on regulatory strategies, solutions to scientific problems and interpretation of results in the context of product registration requirements combined with the business need and goals.Facilitates the communication and flow of regulatory information (regulatory framework, scope and project timelines) to all relevant stakeholders.Identifies and recommends the most effective CMC regulatory strategies to assure a first-pass regulatory approval of initial application and lifecycle supplements/variations.Interfaces with key GMS and PDT BU R&D functions in the preparation, review and approval of regulatory CMC submissions as assigned to product and programs.In collaboration with the network strategist, develops and manages timelines supporting regulatory submissions, proactively identifies risks and develops adequate risk management solutions in consultation with cross-functional teams.In collaboration with regional and local regulatory colleagues, critically evaluates CMC change controls to ensure all regulatory requirements to implement the change have been fully document in the respective quality management system.Provides tactical and strategic regulatory input and guidance, including active participation in problem solving analysis by assessing and proposing alternative solutions to issues and prepare contingency plans while still meeting regulations.Maintains an ongoing and interactive relationship with regional and local regulatory teams to assure that all aspects of the company's regulatory activities are conducted in full compliance with applicable regulations and at the highest level of ethical standards.Creates high quality, compliant regulatory CMC documents within defined timelines as per the company's PDT BU objectives.  qualifications: 5-7 years' experienceBS  skills: CMC, Regulatory Affairs Operations, Submissions Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

job summary: As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Our partner recognizes the need for innovative care and utilizes Research & Development to further knowledge in Oncology, Neuroscience, Rare Diseases, and Gastroenterology. As a company that brings in over $30 billion in annual revenue, they have established themselves as a biopharmaceutical powerhouse that is changing the world. If you're looking for a position where your work will benefit millions of people, we are waiting for you!   location: Cambridge, Massachusetts job type: Contract salary: $85.00 - 94.28 per hour work hours: 9 to 5 education: Bachelors   responsibilities: We are seeking a highly motivated and qualified regulatory CMC professional for the Global Regulatory Affairs CMC & Device organization in the Plasma-Derived Therapies Business Unit at Takeda. The Global Regulatory Affairs CMC & Device organization is responsible for global CMC regulatory strategies and activities (strategy & authoring) for the PDT BU product portfolio, market launch and product lifecycle management. The Strategist works in a highly matrixed, global product team-oriented environment and ensures close collaboration within the Global Regulatory Affairs CMC & Device organization and with other PDT BU functions and relevant Takeda R&D functions to provide an effective and aligned medical device strategy and submission approach globally, regionally and locally   qualifications: 6-8 years of previous regulatory experience in preparing pre-submissions, 510(k), PMA, IDE and related submissions to FDA CDRHAbility to provide strategic input and technical guidance on regulatory requirements to product development teams and ensure preapproval compliance activities are completed.Lead submission working groups (SWG) for various project and work with cross functional teams to plan realistic timelinesAuthor ongoing regulatory submissionsGuide regulatory operations teams to facilitate timely submissionsCoordinate and lead meetings with FDA during pre-submission review process to ensure agency requirements are understood and addressed, leading to submission clearance/approval.Develop and present options and solutions to regulatory obstacles and emerging issues.Ability to prioritize the regulatory risks and multitask and manage frequent communications to various internal management stakeholdersDrive and support leadership with regulatory decision-making process as neededRemain current on developments, emerging regulatory requirements that affect regulatory submissions of various device types. Maintains knowledge of current and pending regulations through literature, trade journals, professional associations, and by attending conferences.  skills: Regulatory Affairs Operations, Submissions Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).