Associate II, Quality Control

Initial Therapeutics, Inc.; Norwood (MA); On-site; USD 65,000 - 90,000; Full time

Job summary

Moderna in Norwood, MA is seeking a Quality Control Chemistry Associate II to perform cGMP QC Chemistry testing for QC Chemistry, release, stability and in-process samples on the 2nd shift (Sunday–Thursday). You will work with HPLC/UPLC/GC/UV, KF, LIMS, and SOPs to support manufacturing and quality operations.

The role requires ensuring data integrity, assisting with method and equipment troubleshooting, writing and revising SOPs and reports, and contributing to investigations, deviations, and

Responsibilities

• Performs routine analytical chemistry testing (HPLC/UPLC/GC/UV, particle analysis, DLS, KF).
• Supports special projects as assigned.
• Assists with troubleshooting assay methods and equipment.
• Performs data entry and supports data trending.
• Performs lab support: reagent prep, sample management, equipment maintenance, housekeeping.
• Supports authoring of SOPs, protocols and reports.
• LIMS sample result entry and Electronic Assay Form execution in LabVantage.
• Performs HPLC (AEX) and NaOH plate-reader assays for manufacturing stat testing.
• Stability program support.
• Supports junior staff with data review, training and troubleshooting.
• Manage/stock QC lab supplies.
• Write/revise SOPs, protocols and reports.
• Complete and maintain cGMP documentation.
• Participate in quality records: investigations, deviations, change controls, CAPAs.
• Establish and maintain a safe laboratory environment.
• Follow GxP regulations and company policies for compliance.
• Execute tasks per SOPs and work instructions.
• Adhere to Good Documentation Practices and Data Integrity for audits.
• Complete required training.

Skills

HPLC

UPLC

GC

UV

KF (Karl Fischer)

LIMS (LabVantage)

Data entry

SOP writing

Documentation/Data integrity

Troubleshooting

Method support

Quality systems

Tools

LIMS (LabVantage)

Job description

The Role:

Moderna is seeking a Quality Control Chemistry Associate II based at their 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. This role will be working on the 2nd shift Sunday through Thursday.

Here’s What You’ll Do:

• Performs routine analytical chemistry testing including HPLC, UPLC, GC, UV, Particle Analysis and Dynamic Light Scattering, KF, 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 (AEX) and NaOH plate reader-based assays in support of manufacturing process stat testing as needed
• Stability program support.
• Support more junior staff with data review, training, and troubleshooting.
• 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 investigations, 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