
Quality Control Specialist
2 days ago
We are a leading science and technology company. Its life science business offers a broad range of innovative products and services to biotech and pharmaceutical drug therapies businesses. Through dedicated collaboration with the scientific and engineering communities, and as one of the top three R&D investors in the life science tools industry, the brand serves as a strategic partner to customers and helps advance the promise of life science.
Quality Control Specialist is to promote and integrate quality into every aspect of our BioReliance® biologics safety testing business in Singapore. The role is to support the QC operations (environmental monitoring and release of critical raw materials), data integrity and systems administration to ensure that laboratory testing operations are in full compliance with sound scientific practice, GxP and Standard Operating Procedures (SOPs).
The post holder will be able to perform the following functions independently, with mínimal guidance.
- Responsible for BSL-2 Lab environmental monitoring following GMP guidelines (including generation and maintenance of documentation).
- Responsible for raw material release testing and process for release for use.
- Assist in investigations from events or complaints.
- Comply with all applicable policies, procedures and guidelines.
- Comply with Health and Safety Executive regulations and undergo relevant training modules when required and actively takes necessary action when encountering unsafe situations.
- Perform duties according to the principles of Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP).
The above list of job duties is not exclusive or exhaustive and the post holder will be required to undertake such tasks as may reasonably be expected within the scope of the post. Job descriptions will be regularly reviewed to ensure they are an accurate representation of the post
**Who You Are**:
- Graduate degree in life sciences or microbiology or higher related degree
- High science orientation
- Minimum of 2 - 3 years of experience
- Demonstrable scientific expertise in microbiology related works
- Shows a desire and motivation to work in Quality and regulated environment
- Experience of working in Biosafety Level 2 laboratory
- Awareness of Biologics regulatory environment and GMP manufacturing topics
- A proactive approach to all aspects of Quality
- Understanding of data integrity assessment and system administration
Knowledge & Skills:
- Fluent in both written and spoken English
- Ability to complete documentation (both handwritten and electronic) neatly and accurately
- Good communicator, dealing directly and effectively with operational teams and site QA and lab colleagues routinely
- Strong analytical and problem solving abilities
- Organized and logical in defining workload and delivering projects
Core Competencies:
- Technical and problem solving skills
- Has the functional and technical knowledge and skills to do the job
- Can learn new skills and knowledge quickly
- Uses logic to solve problems with effective solutions
- Makes good decision
- Energy and Drive
- Self-motivating; is action-oriented and full of energy for the things he / she sees challenging
- Pursues everything with energy, drive and the need to finish, especially in the face of resistance and setbacks
- Can be counted on to achieve goals, constantly and consistently, pushes self and others for results
- Professional and interpersonal skills
- Relates well to all kinds of people in the organization, builds constructive and effective relationships using diplomacy and tact
- Is seen as a team player, cooperative, easily gains support of peers, encourages collaboration
Additional Local Needs:
- Global mindset and to be willing to engage in conference calls at out-of-office hours.
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