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QA Lab Specialist

Career

QA Lab Specialist

Your Exciting Role

As a Document Control Officer in the management system, responsible to ensure all documents are systematically filed.
Conduct and follow up activity related to product release procedure, starting from collecting Work Order (WO) and Form (FR) documents, ensure the completeness of these documents, and conduct filing for all documents related to product release procedure.
Follow up the customer complaints progress, starting receiving the customer complaints from BD/Sales/Marketing, support in the CAPA investigations, following up the CAPA action plan, after completed, closing the case with documenting the customer complaints data.
Receive and handle non-conformity and incident that had happened, starting from issuing the CAPA request form, support and participate during the investigation and root cause analysis, following up and monitoring the progress until complete.
Responsible for conducting Quality Assurance and Laboratory activities, including supporting general laboratorium necessity for Technical Teams (Operations and R&D Teams).
Creating SOP, WI, WO, FORM, and others related to the document management system, especially in the scope of Operations.
Conduct examination and re-check the stock of materials/reagents/consumables regularly, make sure that stock of the material is always available, fresh, no expired material/reagent, and reports immediately for any issue related to material/ reagent/ consumables to the superior.
Creating PR, following up the approval process up to receiving the goods, and documenting all documents related to inventory monitoring activities.
Preparing the procurement of tools, equipment, and stationery that are needed in the laboratory.
Supporting QC/Lab Analyst, Lab Admin, and QA/QC/Lab Lead related creating PR and other forms related to Repair, Maintenance, and Calibration activities, following up the progress (including following up for the approval process and for the repair and maintenance, also a calibration report from vendor), and documenting documents related to these activities.
Conduct physical stock (stock opname) of the inventory for the general laboratory, regularly (monthly or as per the schedule set and prepare the stock opname result to the superior).
Create weekly and monthly performance reports for technical operation activities.

Ideally, You Would Have

Passionate in preserving Indonesia biodiversity through sustainable innovations.
Bachelor of Science in Biology, Pharmaceuticals, Chemistry, Chemical/Industrial Engineering or other related major.
Having at least 1 year of experience in the QA/Lab Operational and Quality Management System.
Fresh graduates who have attended one or more training such as GMP, GLP, CPAKB, CPOIB, CPOHB, ISO 9001, ISO 13485 and/or ISO 17025, are welcome to apply.
Having knowledge of GMP, GLP, CPAKB, CPOIB, CPOHB, ISO 9001, ISO 13485 and ISO 17025 is an added value.
Experience in the molecular biology techniques is an added value.
Good computer skills, i.e. experience in Google Workspace (Sheet, Slides & Docs) or MS Office (Excel, Word and PPT).
Have high integrity, honesty, dynamic, and excellent attention to detail.
Able to work with a team, able to communicate well, and good interpersonal skills.
Thorough & nimble, finished report within time scheduled.