QA Associate Job Description

QA Associate Job Description Template

Our company is looking for a QA Associate to join our team.

Responsibilities:

  • Assist and delivers training relating to Supplier Qualification process (BISQUIT tool in GoTrack) to Fremont staff;
  • Receiving of external samples and log in internal quality system;
  • Quality release of raw materials and finished products;
  • Ensure adherence to GMP good documentation practices;
  • Collect, interpret and give suggestions for process and product improvement;
  • Assist in document control activities (training records entries, logbook issuances, logbook archival etc.);
  • Generation and review of Annual Product Reports;
  • Generates and facilitates changes to SOPs, policies, training materials, and other documents for a technical discipline;
  • Focusing on continuous improvements on SQM process and any related Quality Systems impacting SQM through project management skills and accountability;
  • Notify management of quality/compliance trends and service failures;
  • Provide QA support during manufacturing operations;
  • Perform Raw Material sampling, In-process and Finish Product sampling and coordinate submission of samples to QC analysis;
  • Document internal audits and other quality assurance activities;
  • Support the Supplier change notification process;
  • Support QA function in additional jobs assigned by Supervisor as and when required.

Requirements:

  • 6-8 years’ experience in pharmaceutical manufacturing with minimum 1-2 years’ experience in quality assurance and/or compliance related fields;
  • Proficient knowledge of a GMP production facility, manufacturing and packaging processes, and quality compliance;
  • Bachelor’s degree required (life science/medical technology preferable) or equivalent work experience;
  • Experience with Trackwise;
  • Knowledge of cGMPs, QA, QC and manufacturing/quality processes;
  • Provide QA support during manufacturing operations;
  • Support QA function in additional jobs assigned by Supervisor as and when required;
  • Perform Raw Material sampling, In-process and Finish Product sampling and coordinate submission of samples to QC analysis;
  • Solid knowledge of cGMP is a must. This position will require the ability to interpret and relate quality standards for implementation;
  • Assist in document control activities (training records entries, logbook issuances, logbook archival etc.);
  • Receiving of external samples and log in internal quality system;
  • Ensure adherence to GMP good documentation practices;
  • Quality release of raw materials and finished products;
  • Performs other functions as required or assigned;
  • Complies with all company policies and standards.