- Expiry Date: 23 September 2022
- Referral: firstname.lastname@example.org
The Analyst II, Quality Control will help in the implementation of laboratory equipment and enterprise/local software systems at company’s GMP laboratories in Norton, MA supporting drug substance manufacturing.
This position will be heavily focused on Laboratory Equipment Qualification, Implementation of a LabWare LIMS system, and validation of QC computerized systems.
Demonstrated technical writing and validation knowledge is required.
This position requires flexibility with changing priorities and may require occasional travel to company sites in Cambridge, MA. The role will be based in Norton, MA.
Execute qualification activities, including analytical equipment qualification per USP <1058>. Experience and demonstrated knowledge of analytical systems and software to support lab system implementation.
Contribute to LabWare LIMS system implementation through performance of master data build, validation execution, and setup for QC within established project timelines.
Validate QC computerized software systems associated with laboratory instrumentation in accordance with 21 CFR Part 11 and EU Annex 11.
Collaborate with IT Validation group to ensure all deliverables are met and comply with company procedure.
Author technical documentation (e.g. SOPs, protocols, test scripts, reports, etc.) with guidance commensurate with experience.
Ensure adherence with applicable SOPs, compendia, and in accordance with company and regulatory agency policies and procedures.
Minimum of 2 – 4 years of experience in a GMP laboratory or software validation setting
Experience with QC analytical instrumentation and software systems (UPLC / UPLC-MS, Karl Fischer, FTIR, TOC, spectroscopy, etc.)
Knowledge of analytical equipment qualification per USP <1058>, and software validation in compliance with 21 CFR Part 11 and EU Annex 11 are desired
Experience with LabWare LIMS and design/implementation is ideal
B.S. in applicable science field
About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities
ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.
Full Name: Sufiyan Sheth
Email ID: email@example.com