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.