EXECUTIVE - QA (MICROBIOLOGIST)

Hartalega NGC Sdn Bhd; Sepang; Vor Ort; MYR 39.000 - 61.000; Vollzeit

Zusammenfassung

Hartalega NGC Sdn Bhd in Selangor, Sepang is seeking a microbiology specialist to perform standard testing for sterility, endotoxin, bioburden, and efficacy on materials and products. You will follow validated methods per company and regulatory requirements and assist with SOP updates.

The role requires a Bachelor degree in Microbiology with hands-on lab experience and knowledge of GLP/GMP practices. Candidates should be able to work with diverse lab instruments and maintain accurate records.

Qualifikationen

• Bachelor degree in Microbiology or related field; minimum 2 years in a lab setting.
• Experience with antimicrobial substances or products is advantageous.

Aufgaben

• Perform standard microbiological tests for conformance to company, standards, regulatory and specification.
• Test for final sterility, endotoxin, bioburden, and efficacy on raw materials, in-process and final product.
• Ensure instruments are calibrated and functioning per SOPs.
• Maintain and document testing data with data integrity.

Kenntnisse

Microbiology

Laboratory testing

Quality control

Regulatory compliance

Ausbildung

Bachelor Degree in Microbiology

Tools

Autoclave

Spectrophotometer

Incubator

Calibration equipment

Jobbeschreibung

Perform standard microbiological tests for conformance to company, standards, regulatory and specification. Uses a variety of standard laboratory equipment and instrumentation.

Perform test for final sterility, endotoxin, bioburden, efficacy etc. on raw materials, in-process and final product using standardized and validated methods per company, compendia and regulatory requirements.

Prepare materials necessary for performing and executing validations. Assures instruments are calibrated within specifications and function properly in accordance to SOPs.

Assures microbiological media are properly qualified, prepared, tested for sterility and growth promotion, assuring confidence of usage in preparation of product testing and environmental monitoring.

Maintains records of all testing and analysis information of assigned raw materials/ processes/ products on predetermined forms for permanent file and proper entry of information on laboratory forms assuring data integrity is maintained throughout all processes.

Assist in writing and updating standard operating procedures as related to microbiology and as required following company validated procedures and regulatory mandates. Evaluate all data obtained from analysis, identifies discrepancy or deviation, consult with superior and recommends any additional testing.

Reports laboratory and manufacturing problems to superior as related to testing by using available facilities, known techniques and professional expertise to define potential root causes.

Perform investigative testing on projects and other laboratory duties related to microbiology test methodologies.

Plan and perform diversified duties requiring knowledge of a particular field and the use of a wide range of procedures. Involves the exercise of judgement in the analysis of facts or conditions regarding individual problems or transactions to determine what action to be taken within the guidelines or standard practice.

Assist in drafting quality reports for special studies.

Maintain a good housekeeping, good laboratory practice and aseptic technique in the laboratory environment.

Participates in employing involvement team.

Any other duties as assigned by superior.

REQUIREMENTS

Bachelor Degree in Microbiology, Biotechnology, Biochemistry, Environmental Science or any related field.

Minimum 2 years of working experience in the related work scope.

Must have hands-on experience in lab.

Experience working with antimicrobial substance or product is an advantage.

Good knowledge in good laboratory practice and aseptic technique.

Chemicals & Plastics Manufacturing 5,001-10,000 employees

The Hartalega story began in 1988. Our insatiable appetite to constantly surpass our own achievements has transformed what started as a single-line production facility into what we are today, the leading nitrile gloves manufacturer in the world, with a growing capacity to produce billions of gloves every year. We export to over 70 countries across five continents, namely Americas, Asia, Europe, Australia and Africa.

As an industry leader, we pave the way forward through our commitment to innovation. We invented the world's first lightweight nitrile glove, which revolutionalised the industry by shifting the global demand from latex to nitrile gloves. Today, we are home to advanced proprietary manufacturing technology that allows us to safeguard the quality of our products and the efficiency of our operations. Our unrivalled proprietary technology provides us with an important competitive edge as we own the fastest production lines in the industry, producing more than 45,000 gloves per hour.

In all that we do, we are guided by our SHIELD (Synergy, Honesty, Innovation, Excellence, Learning, Dedication) values to do the right thing at all times. As we continue to grow by leaps and bounds, we are single-minded in ensuring that we make a meaningful difference by enriching lives, from the healthcare practitioners and the people they care for to our very own #TeamHartanians, stakeholders and the community. We welcome like-minded individuals to be part of our exciting team. Together, let us make a difference.

The Hartalega story began in 1988. Our insatiable appetite to constantly surpass our own achievements has transformed what started as a single-line production facility into what we are today, the leading nitrile gloves manufacturer in the world, with a growing capacity to produce billions of gloves every year. We export to over 70 countries across five continents, namely Americas, Asia, Europe, Australia and Africa.

As an industry leader, we pave the way forward through our commitment to innovation. We invented the world's first lightweight nitrile glove, which revolutionalised the industry by shifting the global demand from latex to nitrile gloves. Today, we are home to advanced proprietary manufacturing technology that allows us to safeguard the quality of our products and the efficiency of our operations. Our unrivalled proprietary technology provides us with an important competitive edge as we own the fastest production lines in the industry, producing more than 45,000 gloves per hour.

In all that we do, we are guided by our SHIELD (Synergy, Honesty, Innovation, Excellence, Learning, Dedication) values to do the right thing at all times. As we continue to grow by leaps and bounds, we are single-minded in ensuring that we make a meaningful difference by enriching lives, from the healthcare practitioners and the people they care for to our very own #TeamHartanians, stakeholders and the community. We welcome like-minded individuals to be part of our exciting team. Together, let us make a difference.