Onsite QC Chemistry Associate II – 2nd Shift

BioSpace; Norwood (MA); On-site; USD 63,000 - 101,000; Full time

Benefits offered by this job

Healthcare benefits

Well-being programs

Family planning help

Paid time off

Savings plans

Location perks

Job summary

Moderna is seeking a Quality Control Chemistry Associate II at our Norwood, MA site to perform cGMP QC Chemistry testing for QC Chemistry, release, stability and in-process samples on the 2nd shift (Sunday through Thursday).

The role involves routine analytical work (HPLC, UPLC, GC, UV, KF, DLS, particle analysis), data entry, SOPs, LIMS entry, and supporting deviations, CAPAs and investigations while helping to train junior staff and maintain cGMP documents.

Qualifications

• BA/BS in a relevant scientific discipline.
• 2 years of laboratory experience.
• Demonstrated aptitude or ability to learn GxP regulations.

Responsibilities

• 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 troubleshooting 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 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 plan according to the defined timing and the prescribed requalification cadence.

Skills

GxP compliance

cGMP testing

Data review

SOP writing

Education

BA/BS in relevant scientific discipline

Tools

HPLC

UPLC

GC

UV

Particle analysis

DLS

KF

LIMS (LabVantage)

Job description

Moderna is seeking a Quality Control Chemistry Associate II at our Norwood, MA site to perform cGMP QC Chemistry testing for QC Chemistry, release, stability and in-process samples on the 2nd shift (Sunday through Thursday).

The role involves routine analytical work (HPLC, UPLC, GC, UV, KF, DLS, particle analysis), data entry, SOPs, LIMS entry, and supporting deviations, CAPAs and investigations while helping to train junior staff and maintain cGMP documents.