About the job
The Senior Quality Control (QC) Technician is essential in orchestrating and overseeing testing and inspection activities pertaining to our innovative products. This role involves meticulously recording, analyzing, and approving results throughout product development and manufacturing processes. You will also be responsible for environmental monitoring and contamination control efforts. The ideal candidate should bring a versatile skill set and a keen attention to detail, with a robust background in quality control and a solid foundation in Microbiology.
This position is full-time and requires on-site presence.
Key Responsibilities:
Technical:
- Plan, execute, and document inspections and routine testing of incoming materials, utilities, products (both intermediate and finished), and validation samples.
- Organize, schedule, and collect environmental monitoring (EM) samples from production areas and utilities.
- Facilitate the release of incoming (raw) materials.
- Collaborate with external testing laboratories and sterilization facilities for sample submission, testing, processing, and result reporting.
- Establish and maintain QC databases to ensure that pertinent information remains current and accessible to relevant teams.
- Initiate and review Quality Indicators (QIs), including deviations and out-of-specification (OOS) reports related to QC activities.
- Coordinate and conduct equipment calibration and maintenance for QC instruments.
- Engage in product development and risk management activities as required.
- Provide training for existing and new QC personnel as necessary.
- Plan and conduct Quarterly Dose Audits (QDA).
- Support validation activities related to test methods, processes, cleanroom protocols, and equipment.
- Inspect product labels for compliance.
- Review and confirm accuracy, completeness, and compliance of batch production records, QC testing data, and logbooks prior to product release recommendations.
- Maintain relevant equipment, production, and quality records as necessary.
Quality Management System (QMS):
- Assist in developing and maintaining quality control procedures and associated documentation, including specification documents and testing protocols.
- Comprehend applicable quality control requirements.
- Propose enhancements to existing testing methods and identify needs for modifications in the Quality Management System.
- Support the CAPA Process Owner in investigating and resolving non-conformances.
