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Quality Control Analyst II

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POST DATE 9/12/2016
END DATE 10/10/2016

Azzur Group Northborough, MA

Company
Azzur Group
Job Classification
Full Time
Company Ref #
915f1a561
AJE Ref #
576156160
Location
Northborough, MA
Experience
Mid-Career (2 - 15 years)
Job Type
Regular
Education
Bachelors Degree

JOB DESCRIPTION

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Job Description:

We're hiring! Azzur Group is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success. We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers. Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever- changing healthcare field while simultaneously and organically exuding Azzur s core values: PUTS OTHERS FIRST, HAS THE COURAGE TO TAKE ACTION, TAKES PERSONAL RESPONSIBILITY & HAS FUN! ESSENTIAL DUTIES AND RESPONSIBILITIES: Azzur personnel are expected to live up to our core values at all times and exhibit a high level of integrity and personal responsibility, especially when interacting with our valued clients. The following is a short list of the typical responsibilities and deliverables of any given project. The level of knowledge expected will commensurate with the level of incoming experience. The QC Analyst will be responsible for operations necessary for quality testing and playing a role in implementing new technology within quality control. At more senior levels, the Analyst will provide an investigative or technological orientation in designing, executing, interpreting, and validating quality procedures and test methods. Other responsibilites include completing routine testing of raw materials, in-process and final products in accordance with SOPs for product release and validation, as well as aiding in the development of test methods. Other duties include conducting data review and preliminary evaluation of results, solving problems using limited predetermined options such as repeating the assay when parameters are not met to determine the cause, providing input to the technical composition of operating documentation, as well as contributing to the completion of routine technical tasks. Duties include:Execute activities, as assigned, for optimization, validation, transfer, and life cycle management of test methods used for release testing of raw materialsTesting of raw materials utilizing FT-IR, wet chemistry, Karl Fisher, titrations, Polarimetry, Specific Gravity, GC, and RAMANConduct tasks for laboratory equipment qualification and re-qualification programReview compendial updates and initiate workflows for corresponding revision of test methodsCoordinate logistics and communication with contract testing laboratories for supplier qualification testingSupport ongoing readiness for regulatory inspections and compliance auditsRevise SOPsPractice safe work habits and adhere to Company's safety procedures and guidlinesMaintain proficiency training per assigned curricula EXPERIENCE AND QUALIFICATIONS:Bachelor's degree in a related disciplineMinimum of 3-6 years of experience in cGMP laboratory environmentHands-on experience with a broad range of lab equipmentFirst-hand experience with compendial analysis of raw materialsPrevious experience performing cGMP analytical analysesStrong verbal and written skillsPrevious experience with lab control operations and quality systemsPreferred experience with chromatography data systems An ideal candidate will have extensive analytical lab experience that can translate to method and instrument validation and document authoring. Emphasis will be placed on past analytical experience, with technical writing experience being a slightly lower position requirement. Should you be interested in finding out more about this exciting opportunity and working for the Azzur Group, please contact us. Our staff enjoy challenging work, being valued by clients, gaining experience, developing industry expertise/contacts and working for a company that lives its core values. Put Others First .Have the Courage to take Action.......Take Personal Responsibility. ...Have Fun!

Company Description:

Azzur Group is a partnership of companies and talented professionals strategically unified to better serve its customers. They offer a comprehensive service line designed to help businesses throughout every step of the system life cycle. Azzur Group offers consulting services and project resources within the quality assurance, laboratory, clinical, IT/IM, business processes, manufacturing, process engineering, operations and R&D settings. Azzur Group's experienced staff can help with requirements definition, vendor selection, configuration, implementation, testing & validation, calibration, certification and maintenance.