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Quality Control Manager

JOB OVERVIEW:
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.

JOB DUTIES:

• Fully understand cGMP/GLP guidelines and regulatory procedures, including but not limited to 21 CFR Part 11, 21 CFR Part 210, 21 CFR Part 211.
• Maintain compliance with cGMP/GLP guidelines and inputting of Celltex Standard Operating Procedures (SOPs) and GMP/GLP guidelines, applying them as required.
• 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. Hands-on tests if it is needed.
• Verify packaging and document the shipment of all outgoing stem cell and related products.
• Review all QC testing data and specifications.
• Review/Prepare Certificates of Analysis (CoA) for all outgoing stem cells and related products.
• Train and educate laboratory personnel to perform their assigned laboratory duties.
• Demonstrate proficiency in good documentation practices.
• Maintain all paper and electronic documents and logs associated with QC testing.
• Inventory and order all supplies needed in QC.
• Solve problems by examining and evaluating data, as well as implementing corrective action when necessary.
• Oversee/Perform/Review laboratory investigations and OOS and OOT analysis, assist with follow-up of alert limit.
• Oversee/Write/Review Deviation/OOS investigation reports.
• Participate in Quality Control validations/verifications, calibrations, and qualifications as needed.
• Attend and participate in group and project meetings.
• Write, revise and review related 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.
• Work with Manufacturing and Quality Assurance departments, and correspond/collaborate with other departments.
• Communicate with upper management to ensure the Quality Control unit operates efficiently and effectively. ​

SKILLS/QUALIFICATIONS:

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.

EDUCATION/EXPERIENCE:

Bachelor’s degree in biology or microbiology and at least 5 years of experience in a Quality Control 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.

REPORTS TO: Lab Manager

DEPARTMENT: Quality Control

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Celltex Therapeutics Corporation is a U.S. Equal Opportunity Employer.