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Randstad US qa/qc specialist ii in lexington, Massachusetts

qa/qc specialist ii.

  • lexington , massachusetts

  • posted 7 days ago

with

randstad indeed

job details

summary

  • $34 - $37.54 per hour

  • contract

  • bachelor degree

  • category life, physical, and social science occupations

  • reference39767

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job details

job summary:

As the world's 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!

This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation.

location: Lexington, Massachusetts

job type: Contract

salary: $34.00 - 37.54 per hour

work hours: 9 to 5

education: Bachelors

responsibilities:

  • Primary duties of the position are focused around non-laboratory support of the QC functions.

  • Primary activities would generally include but not limited to analytical method transfer, analytical method validation, data analysis, data trending, project and testing coordination product and material specification management, inspection support, document authoring, revisions, initiating/completing quality systems, method/equipment validation and method projects activities.

  • Contributes to the completion of organizational projects and goals.

  • Errors in judgment or failure to achieve results would normally require a moderate expenditure of resources to rectify.

  • Area is focused on data analysis, data trending, project and testing coordination product specification management, LIMS interface, CoA generation,(including interaction with the IT systems such as LIMS that enables electronic management of this activity), and inspection support.

  • Area is focused on data analysis and trending of stability data, data reporting, coordination and planning of stability studies, involvement on quality events requiring stability input.

  • Area is focused on various technical projects in support of the GMP laboratories, such as automation support, method projects activities (ex. method transfer and validation support activities, method monitoring), critical reagents and reference standard programs.

  • 50-60% data analysis, data trending, project and testing coordination, support of product specification management, COA generation,material specification creation, document revisions.

  • 20-30% Regulatory and/or inspection support, method projects activities, initiating/completing quality systems.

  • 20% Involvement in other QC activities as required (ex. Records Retention)

qualifications:

Essential:

  • Experience in Analytical Method Transfer, Analytical Method Validation, HPLC, Bioassays, CE assays, compendial verification, biologics

  • Normally requires a bachelor's degree and a minimum of 2 years of related experience. (Science related degree is preferred)

Additional Specific Experience:

  • Excellent communication, interpersonal and organizational skills. Ability to work well both independently and in a team environment. Ability to prioritize work and multitask.Conducts work in compliance with cGMPs, safety and regulatory requirements.

  • Frequent use and general knowledge of industry practices, techniques, and standards. General application of concepts, and principles. Position requires critical thinking.

Key Skills:

  • MS Office, LIMS, SAP, Trackwise, EDMS, compliance and strong science understanding

  • Develop solutions to a variety of problems of moderate scope and complexity.

  • Refers to policies and practices for guidance.

  • Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.

  • Exercises judgment within defined procedures and practices to determine appropriate action.

  • Builds productive working relationships internally and externally.

The following physical abilities are required in order to fulfill the job duties:

  • Repetitive bending and reaching to setup and break-down equipment (if required by specific activity)

  • Ability to work around chemicals (if working around the laboratories)

  • Ability to wear personal protective equipment such as gloves, gowning, and respiratory protection in some cases

  • Ability to walk and stand for periods of time

  • Individual may be required to participate in environmental chamber monitoring program which would include the use of an on-call mobile phone as well as on-site support during non-business hours

skills: HPLC, MS-WORD, MS-EXCEL, MS-Powerpoint, LIMS (Laboratory Information Management System

For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.

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.

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