Quality Control, Chemistry Data Testing

3 weeks ago

Norwood, United States Randstad Life Sciences US Full time

Associate II, Quality Control, Chemistry Data - 1ST Shift SUN-WED

6 Months- likely to go much longer

Norwood MA


MUST HAVE:

data review/assay experience as well as HPLC, UPLC, GC, UV, Particle Analysis and Dynamic Light Scattering, Spectramax Plate Reader, Osmolality, pH, KF, appearance, etc. in a cGMP environment


Shift: 1st Shift Sun – Weds 6am – 4pm or 7am – 5pm


Job Summary


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.

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