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Quality Control Scientist

5+ years
Not Disclosed
10 Jan. 18, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc. Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position: Quality Control Scientist
Location: Marlboro, MA 01752
Employment Type: Contract
Job Category: Scientific
Job Number: 616791
Is Job Remote?: No
Country: United States


Job Overview

This position focuses on Quality Control testing of in-process and final products, particularly in cell culture, RT-qPCR, Immunofluorescence, and cell-based assays. The role is onsite and requires experience in various QC testing methods, analytical method validation, and troubleshooting.

Essential Job Responsibilities

  • Perform routine in-process and release QC testing of cell products.
  • Execute analytical method validations and transfers, including drafting technical protocols and reports.
  • Maintain, calibrate, and operate equipment for cell bioassays, Flow Cytometry, ELISA, and PCR assays.
  • Track and test products following stability protocols.
  • Work with internal and external resources to maintain the lab in optimal condition.
  • Monitor and trend data, complete routine record reviews for in-process testing, drug substance, and product release.
  • Develop, revise, and review SOPs, qualification/validation protocols, and reports.
  • Investigate out-of-specification (OOS) results and manage deviations related to analytical procedures.
  • Ensure compliance with GMP systems and documented policies.
  • Perform additional lab duties as required.

Required Qualifications

  • Bachelor’s or Master’s degree in Biotechnology or a related field with 5+ years of Quality Control experience.
  • Knowledge of GMP, SOPs, and quality control processes.
  • Experience in the biotech or pharmaceutical industry.
  • Ability to work weekends as required.

Additional Information

Planet Pharma is an equal opportunity employer committed to diversity, equity, and inclusion.