• The Compliance Specialist CMC, Quality Assurance

    Belcan (Marlborough, MA)


    The Compliance Specialist CMC, Quality Assurance

     

    Job Number: 360525

     

    Category: Quality Inspector

     

    Description: Job Title: The Compliance Specialist CMC, Quality Assurance

     

    Zip Code: 01581

    Duration: 4+ Months

    Pay Rate: $46.67/hr

     

    Keyword's: #Marlboroughjobs; #QualityAssurancejobs.

     

    Start Date: Immediate

    Job Description:

    Essential Duties and Responsibilities include, but are not limited to, the following:

    * Performs QA review of executed development studies intended for regulatory submissions, included but not limited to draft batch records, analytical test records, and calibration records to ensure Developmental studies are conducted and data collected in compliance with approved protocols, appropriate Corporate guidelines, internal procedures, domestic and global regulatory guidelines and standards. Identifies and reports documentation errors and deviations from Protocols, SOPs or specifications in a timely manner.

     

    -Responsible for communicating QA review, audit results and reporting.

     

    -Collaborates with cross-functional stakeholders regarding quality events, ensuring quality records are clearly written and technically sound with supporting evidence.

    Qualifications:

    -BS/BA in Life Sciences, Engineering, or Chemistry, with 2-3 years of related Quality Assurance experience within GMP-regulated industry, or 1-2 years with Masters degree. In lieu of a Life Sciences degree, consideration will be given to candidates with minimum of 6+ years of industry experience in biotechnological and/or pharmaceutical quality, manufacturing, or other industry requiring high technical aptitude and attention to detail.

     

    Belcan is an equal opportunity employer. Your application and candidacy will not be considered based on race, colour, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, state or local laws.

    Minimum Experience (yrs):

    Required Education: Not Specified

    Benefits:

    Return to search results Email this job to a friend (emailjobs.asp?jo_num=360525)

     

    If you have previously registered with us, pleaseLog in (memberlogin.asp) to apply for this position.

     

    *Logged in members may also add jobs to their job cart