QA Associate Specialist

4 weeks ago

Kuala Lumpur, Malaysia Ansell Healthcare Full time

**Requirements**
- Prefer Malaysian only
- Diploma with minimum 10 years working experience or Degree with minimum 5 years working experience in the Lab environment that practicing ISO/IEC 17025, prefer Lab Senior Supervisor or Lab Section Head.
- To ensure good quality control on in-coming and in-process materials and outgoing finished gloves properties to support the smooth running of production
- To maintain an environmental management system as defined by the ISO 14001
- To maintain a quality management system as defined by the ISO 9001
- To maintain a laboratory management system as defined by the MS ISO/IEC 17025 To maintain 5S and Good Manufacturing Practice (GMP) as per requirement.
- Decide Acceptance/Rejection - on in-coming material and in-process materials.
- Decide acceptance/rejection on finished products physical and chemical properties
- Decide Acceptance/Rejection - on calibrated/verified measuring equipment.
- Select new laboratory assistants & recommendation of staff promotion.
- Decide on laboratory ongoing training and cross checking, procedures and practices.

**Job Descriptions**
- In-coming Raw Material Quality Control

To review all the in-coming raw material records and to take action accordingly when there's any issue regarding the receiving, checking and inspection.
To evaluate supplier/new supplier based on conformance or deviation from the new material quality specification.
- In-process Materials Quality Control

To ensure that procedures for in-process inspection and testing activities are documented and adequate.
To ensure that in-process inspection and testing are in accordance to quality plan and records of verification are maintained as per quality plan
To ensure that in-process material is not used or processed (except due to urgency which shall then positively identified and recorded to permit recall) until it has been inspected/verified as conforming to the specified requirements.
- Finished Gloves Properties Testing

To ensure that procedures for finished glove physical properties/chemical properties testing are documented and adequate.
To ensure that glove physical properties/chemicals properties testing are in accordance to quality plan and records of verification are maintained as per quality plan
To ensure all finished glove physical properties/chemicals properties are conformed to the Internal Finished Product Specification.
- SAMM Laboratory

Provide training, methods and test procedures to the Laboratory staff.
Reviewing of request and report of the Laboratory testing and procedures.
To calculate measurement of uncertainty for new testing.
Initiate actions to prevent or minimize departure from the system.
To consistently ensure laboratory technical and day to day operation of SAMM Lab in compliance with ISO/IEC 17025 and Standard Malaysia requirement
- Equipment Calibration/Verification.

To ensure that inspection, measuring and test equipment that could affect quality are identified, control and calibrate/verify at appropriate intervals.
- To ensure that the process and procedure for equipment calibration/verification are documented and adequate.
To ensure that the status of calibration/verification is suitably identified on the equipment/appropriate means and calibration/verification records are maintained. - To ensure that the environmental conditions are suitable for the calibrations/verifications, inspection, measurements and test being carried out.
To ensure that the handling, preservation and storage of inspection, measuring and test equipment is such that the accuracy and fitness for use are maintained. - To ensure adjustable equipment is safeguard by suitable means to prevent adjustment.
- To ensure external calibration is carried out as schedule and calibration certificate is properly maintained.
- New Supplier Assessment on Raw Materials

To monitor and evaluate the existing supplier quality performance and identify needs for new supplier assessmentTo compare the product specification of materials supplied by existing and new supplierTo evaluate supplier based on conformance or deviation from the new material quality specification.
- Quality System

To periodic review Laboratory procedure and activities to ensure meeting ISO9001 Quality Management system requirement.
- To revise Lab SOP to reflect actual practice.
- Training

To prepare training materials, conduct training and to audit QA Laboratory staff periodically to ensure consistency in testing performance and proper recording of testing results.
To train QA Laboratory personnel on Quality, Laboratory (SAMM), Environmental and Health and Safety related matters.
To evaluate the effectiveness of the training conducted.
- Quality, Safety and Environmental Responsibilities

To carry out Environmental Impact Analysis for any new process/testing introduce to the Laboratory.
- To ensure collection, handling and disposal of laboratory waste carried out by subordinates are in compliance with waste manag

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