Seeking a Quality Control Chemistry Associate II based at Norwood, MA site. The individual in this role will perform cGMP QC Chemistry testing for QC Chemistry, release, stability and in process samples. This role may support special projects as needed.
Job Responsibilities
Performs routine analytical chemistry testing including HPLC, UPLC, UV, Particle Analysis and Dynamic Light Scattering, etc.
Supports special projects as assigned.
May assist with Troubleshoots assay methods and equipment.
Performs data entry and supports trending.
Performs general laboratory support activities including reagent preparation, sample management, equipment maintenance, lab housekeeping etc.
Supports authoring of SOPs, protocols and reports.
LIMS (LabVantage) sample result entry, execution of Electronic Assay Forms in LIMS
Perform HPLC and NaOH plate reader based assays in support of manufacturing process stat testing as needed
Stability program support
Managing/stocking of QC lab supplies
Write/revise SOPs, protocols and reports.
Complete and maintain cGMP documentation for work performed.
Participate in authoring quality systems records such as deviations, change controls, CAPAs
Establish and maintain a safe laboratory working environment.
Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.
Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.
Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.
Education & Qualifications
Education: BA/BS in relevant scientific discipline
Experience: 2 years of Laboratory experience.
Demonstrated aptitude or ability to learn in order to gain a strong understanding of GxP regulations.