|Job Title:||Quality Control Manager||Status:||Full time|
|Department:||Operations - Quality Control||Reports to:||VP of Operations|
The Quality Control Manager (QC Manager) is a vital position in the operations of Celltex's laboratory services. The primary responsibility of the QC Manager is to supervise the quality control portion of the laboratory, performing all aspects of sterility, endotoxin and mycoplasma testing, and viability determination on stem cell and related products.
- Supervise all QC activities and personnel
- Oversee sterility, endotoxin and mycoplasma testing, cell counts, and viability testing to ensure samples are within the established acceptance criteria
- Verify packaging and document the shipment of all outgoing stem cell and related products
- Review all QC testing data and related calculations
- Prepare Certificates of Analysis (CoA) for all outgoing stem cell and related products
- Train and educate laboratory personnel to perform their assigned laboratory duties
- Maintain all paper and electronic documents and logs associated with QC testing
- Inventory and order all supplies needed in QC
- Maintain a full understanding of Celltex Standard Operating Procedures (SOPs) and GMP/GLP guidelines, applying them as required
- Solve problems by examining and evaluating data, as well as implementing corrective action when necessary
- Attend and participate in group and project meetings
- Assist in the development and writing of SOPs, as necessary
- Monitor expenditures related to QC activities and programs and assist in budget preparation
- Enhance laboratory and organizational effectiveness by accepting responsibility for accomplishing laboratory operational goals and doing so with the highest quality and integrity
- Assist in special projects, as requested
Detail-oriented. High degree of organization. Ability to accurately record data and document all activities.
Team player. Excellent communication skills. Ability to multi-task. Utilize aseptic technique. Maintain knowledge of quality control testing methods.
Master's degree in biology or microbiology and at least 8 years of experience in a laboratory environment. Experience must include, but not be limited to: aseptic technique; environmental monitoring, GMP/GLP guidelines, and testing techniques such as sterility, endotoxin, mycoplasma, gram staining, and cell counting.