Quality Control Chemist
Quality Control Chemist
Job Number: 20-04790
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Quality Control Chemist for our client in Andover, MA.
Eclaro’s client is among the world’s largest pharmaceutical companies, trusted by billions to provide superior, cutting-edge, and inexpensive medicine that improves health and well-being. If you’re up to the challenge, then take a chance at this rewarding opportunity!
- 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 remediations
- 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.
- 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.
If hired, you will enjoy the following Eclaro Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
Maria Castañeda | LinkedIn
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.