About the role

AI summarised

QC Associate at a global biopharma company in Singapore, performing routine laboratory testing, sample handling, and data recording to ensure materials and products meet regulatory and company standards. The role involves biological testing, environmental monitoring, equipment maintenance, and participation in investigations and method transfers.

BiopharmaFull-time{'name': 'Quality'}

Key Responsibilities

Perform routine and adhoc/non-routine testing in the following areas with good observation of GMP requirements: Biological testing of raw materials (biochemistry and/or microbiological testing), Biological testing of intermediates and product, Biological testing of utilities samples (e.g. city water, purified water, water for injection, compressed gases, etc.), Biological testing required to support manufacturing process validations and confirmations, Perform routine environmental monitoring of classified environment.
Initiate and participate in laboratory investigation (OOS / deviations / atypical results / invalid results) and assist in timely closure of the investigation and CAPA.
Perform equipment maintenance and validation.
Participate in method transfer / verification / validation.
Participate in peer review for verification of task and data.
Assist in SOP writing.
Identify and report problems observed/encountered to QC Superintendent in a timely manner.
Practice 6S and ensure good housekeeping of laboratory, work area and equipment.
Ensure good inventory of QC materials (purchased and prepared materials / glassware) to support testing; ensure no over surplus of inventory.
Participate in GPS initiatives for continuous improvements.
Ensure wastes are disposed appropriately and promptly.
Adheres to all safety and security policies and practices.

Requirements

Min diploma in Microbiology, Biotechnology, Life Sciences, Chemistry, Biochemistry
Basic laboratory experience or coursework in chemistry, biology, pharmaceutical or related field.
Comfortable working on-site in Singapore (this role is on-site).
Good written and spoken English.
Ability to follow instructions and document work clearly.
Willingness to work safely with reagents and laboratory equipment.
Experience with routine analytical techniques and laboratory instruments.
Familiarity with good laboratory and documentation practices.
Basic computer skills, including Excel and laboratory systems.
Strong attention to detail and ability to manage time and priorities.
A collaborative approach and desire to learn and grow in a regulated environment.