Job Title: QC Chemist I Work Location: Andover, MA
Duration: 18 Months (Possibility of Extension) on W2
This role will provide support to the QC Analytical department for activities required to maintain CGMP status of QC Instrumentation hardware and software and to perform comparability studies for implementation of analytical assays on new instrumentation. This scope includes QC Instruments (both portable and computer-controlled).
Authoring Corrective & Preventive Action plans (CAPAs) for systems with long-term remediation activities, and authoring final reports for systems with short term/completed remediation’s
Performing supporting remediation work in the form of SOP revisions as well as authoring and executing change controls and validation test plans/protocols when required per remediation plans
Develop, drive and perform comparability studies for implementation of analytical assays on new instrumentation.
Successful candidate requires:
Strong working knowledge of the validation lifecycle including computer system validation, 21 CFR Parts 210 and 211, and Part 11, Electronic Records and Electronic Signatures.
Working knowledge of data integrity regulations, guidance, and principles
Working knowledge of CAPA and change control processes
Strong interpersonal, oral and written communication skills as there is a high degree of collaboration required between members of QC, QA Validation, Instrument Validation, and IS/IT functions.
Knowledge and experience with a wide variety of analytical techniques including HPLC, UV/VIS, CGE, FT-IR and ICE.
A BS degree in science, engineering, computer science, or related technical discipline with minimum 2-3 years pharmaceutical/biopharmaceutical experience in a relevant GMP role (validation, quality control, quality assurance, IS/IT compliance, etc.)
Past experience working with QC instrumentation in the biopharmaceutical field is preferred but not required.
What is the minimum education experience required?: Bachelors or Masters in Science field. PHDs will not be considered
Help us improve CareerBuilder by providing feedback about this job:
Report this job
Report this Job
Once a job has been reported, we will investigate it further. If you require a response, submit your question or concern to ourTrust and Site Security Team
privacy and protection,
when applying to a job online, never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction.Learn more.
By applying to a job using CareerBuilder you are agreeing to comply with and be subject to the CareerBuilder
Terms and Conditions
for use of our website. To use our website, you must agree with the
Terms and Conditions
and both meet and comply with their provisions.