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Compliance Specialist

Alten Calsoft Labs

Compliance Specialist

Southborough, MA
Full Time
Paid
  • Responsibilities

    Job Description

    Review of Quality Critical Alarms and NRSR

    Review J&Cs

    Metric entry into database

    Initiate and investigate deviations for non-conformance

    Conduct deviation containment assessment (off-hour support)

    Provide off-hour support for batch record issuance

    Function as back-up for QA Manager

    Other activities as assigned

     

    QUALIFICATIONS:

    An ongoing commitment to conducting our global business according to the highest legal and ethical standards,

    and to continually pursue excellence in the development and delivery of all of our products and services. This

    includes:

    Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our

    own Company policies and procedures.

    Being honest and treating people with respect and courtesy.

    Constantly striving to make Genzyme a great place to work, and a company respected for the quality of its

    people and products.

    Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and

    exercising sound judgment in performing our jobs.

     

    BASIC QUALIFICATIONS:

    Bachelor’s Degree in a scientific field and 4-6 years experience in a Quality and /or other cGMP related field,

    or Master’s Degree in a scientific field and 2 years’ experience in above.

    2 years of experience in a Quality role.

    Knowledge in external agency regulations (FDA, EMA, etc.)

    Strong computer, verbal and written communication skills.

    Experience in quality systems.

    Experience in leading cross functional team.

    Experience with Track wise or equivalent system.

    Proficient in Microsoft Office.

  • Qualifications

    Qualifications null Additional Information

    All your information will be kept confidential according to EEO guidelines.