Quality Control Scientist I in Framingham, MA at Integrated Resources, Inc

Date Posted: 1/16/2020

Job Snapshot

Job Description

Position Summary
Quality Control Validation Scientist I is responsible for the qualification activities, following SOPs and regulations including Data Integrity, related to one or more of the following areas: IQ, OQ, PQ and requalification.
Core Responsibilities
Perform qualification in a cGMP biotech manufacturing facility managing multiple complex qualification projects and providing technical assistance to less experienced team members.
Write, review and approve qualification protocols and reports as well as execute protocol. Resolve protocol discrepancies and deviations.
Evaluates new technologies platforms for implementation in the QC Laboratories.
Ensure GMP compliance of all activities performed.
Represent QC Validation in internal and external audits as required.
Ensure appropriate facility support and provide technical expertise with regards to equipment.
Review standard operating procedures.
Maintain positive relationship and network effectively across sites and organizations.
Provide project oversight and participate in cross-functional teams.
Practice safe work habits and adhere to Client's safety procedures and guidelines.An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:
Perform other additional job related duties as required.
Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our Company policies and procedures.
Being honest and treating people with respect and courtesy.
Constantly striving to make Client a great place to work, and a company respected for the quality of its people and products.
Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Ability to present technical data.
Ability to work independently on scientific projects.
Scientific technical writing ability authoring and reviewing SOPs, qualification protocols and technical reports.
Experience troubleshooting of assay and equipment issues
Knowledge of Validation Lifecycle Approach.
Skills:

Required

  • CGMP
  • DATA INTEGRITY
  • LIFE SCIENCES
  • EQUIPMENT VALIDATION


Additional

  • QUALITY CONTROL
  • SOPS
  • GMP
  • LOCKOUT/TAGOUT
  • PROJECT OVERSIGHT
  • SAFETY PROCEDURES
  • TECHNICAL ASSISTANCE