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Company: MMC Laboratories Limited
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Overview
ABOUT US
MMC Laboratories Limited is building a compliant, ethical and regulated profitable Cannabinoid Active Pharmaceutical Ingredient (API) facility. As we continue to grow and expand, we seek a skilled and experienced Quality Control Coordinator and Quality Assurance Assistant to join us and contribute to our overall success.
QUALITY CONTROL COORDINATOR (QCC)
JOB SUMMARY
The Quality Control Coordinator (QCC) reports to the Chief Scientific Officer (CSO). The Quality Control Coordinator will stay conversant on all quality control operation requirements for an API manufacturer to ensure the Quality Control Laboratories and associated activities throughout the facility are compliant and continuously improved upon. The Quality Control Coordinator will ensure the analytical/ microbiology and product development laboratories are in operation mode to support production and the release of products as well as continues improvement.
KEY RESPONSIBILITIES
- Responsible for coordinating QC laboratory operations in accordance with GMP, customer and company requirements. Coordinate, organize and maintain all department and laboratory processes, procedures and administrative duties.
- Act as liaison with external parties on matters relating to QC testing status, approvals, rejections, documentation status, and any other QC matters to support all internal departments and customers.
- Assure that all raw materials, bulks, and finished goods are tested in accordance with all regulatory and customer requirements, as applicable.
- Coordinates process optimization program that includes continual improvement programs for analyses, human capital development and management systems.
- Take lead responsibility with contract laboratories supporting outsourced testing, method development and assay validation activities.
- Investigate deviations and write exception documents as required, utilizing problem solving tools as needed.
- Liaise with the QA team to investigate processing Deviations, Out of Specifications, and Out of Trend, QC events. Identify and report non-conformances/deviations/out-of-specification events.
- Proficiency in Microsoft and quality management software applications, documentation
EDUCATION/ EXPERIENCE REQUIREMENTS
- 5+ years of QC lab experience in biotech/pharmaceutical industry in a GMP environment is required.
- Method validation experience required.
Experience implementing and maintaining departmental metrics. - Prior experience working with external testing laboratories and CMO development and manufacturing partners is highly desirable.
- Bachelorโs degree in science or related field required.
- Demonstratable coordinator and organization skills.
- Excellent oral and technical writing skills with the ability to interface effectively and professionally at all levels.
- Communicate clear work plans, coordinate staff schedules, training and standardize work hours with staff when possible.
- Work with various staff members to evaluate and improve processes, through informal and formal channels
- Ability to work on cross-functional teams and apply influencing skills in a matrix environment.
- Experience in operating Chromatography, Spectroscopy and Microbiology instruments.
HOW TO APPLY
Interested candidates are encouraged to submit their resume with three traceable references and application cover letter to recruitment@mmclaboratories.com not later than 6th September 2024.