Senior Quality Control Coordinator

FLSA Classification: Exempt/Salary  

Schedule: Monday – Friday; 0800 – 1700; On-Site with occasional off-shift hours and weekends or holiday shifts. 

Department: Global Quality Operations

Reports to: Quality Control Manager

Supervisory responsibilities: No 

Location: 13203 Murphy Rd, Suite 100 Stafford, TX 77477 

Position Summary/objective: 

The Senior Quality Control Coordinator will work directly with Quality Control Management to coordinate the cleaning and maintenance of QC equipment, ensure required QC documentation is available and accurate, and assisting QC Management in coordinating laboratory operations. Serving as a liaison for QC lab personnel, they will work with QC management to ensure the availability of required PPE, coordinate waste disposal, and uphold safety protocols. 

Essential functions: 

•  Oversees calibrations, maintenance, and repairs of laboratory equipment, ensuring optimal functionality and productivity. 

• Work with the Field Engineering team for vendor coordination, equipment servicing, addressing malfunctions promptly and maintaining GxP compliance. 

• Coordinate, in collaboration with other team members, equipment validations. 

• Perform routine equipment maintenance and troubleshooting. 

• Conduct and document all activities consistent with cGMP/GxP, regulatory filings, and written procedures. 

• Maintain data integrity and logs for equipment.  

• Ensure critical QC documentation is requested and available as needed for testing purposes. 

• Transport controlled documents between OQS and the QC laboratory. 

• Assist QC Management with group tasks scheduling. 

• Coordinate sample request for non-routine sample transfers. 

• Coordinate, in collaboration with other team members, purchasing of materials and reagents. 

• Assist in upholding laboratory safety protocols and procedures. 

• Involved in the creation of systems used in quality control to maintain compliances with regulations. 

Secondary functions: 

• Train junior analysts. 

• Transport human biological samples between manufacturing facility and QC laboratory. 

• Perform release assays for cell product identity and safety, which includes the use of different laboratory methods such as microscopy, visual inspection, cell count & viability, flow cytometry, cell culture, immunoassays, DNA isolation, PCR, sterility, endotoxin, and mycoplasma. 

• Safely handle human biological specimens. 

• Extract, compile, and analyze data.  

• Generate, report, and track results. 

Competencies:  

• Initiative 

• Problem Solving 

• Very detail oriented 

• Strong analytical, technical writing, verbal communication, and interpersonal skills 

• Ability to work independently and manage multiple projects with aggressive timelines 

Work environment: 

 This position works in a typical office and/or clinical lab environment with moderate noise levels and uses phone, computer, office equipment and supplies on a regular basis. While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, fumes or airborne particles, pathogens and toxic or caustic chemicals. The employee is occasionally exposed to wet and/or humid conditions, risk of electrical shock, sharps, or cuts, while performing tests. 

Physical demands: 

• Communicating Verbally – expressing or exchanging ideas by means of the spoken word to impart oral information to others to convey detailed spoken instructions or other workers accurately, loudly or quickly. 

• Hearing – the ability to hear, understand, and distinguish speech and/or other sounds one-on-one, group or conference, telephone, and other sounds. 

• Keyboarding – entering data or text into a computer or other machine by means of a keyboard. Devices include a traditional keyboard, 10 key-pad, touch screens and others.  

• Lifting - raising or lowering an object (up to 25 lbs) from one level to another (includes upward pulling). Carrying is to transport an object – usually by holding it in the hands or arms but may occur on the shoulder. 

• Near Visual Acuity – clarity of vision at approximately 20 inches or less (working with small objects, reading small print, including the use of computers).  

• Pushing - Exerting force upon an object so that the object moves away from the object. 

• Pulling - Exerting force upon an object so that the object moves toward the force.  

• Sitting – remaining in a sitting position for at least 50% of the time. 

• Standing/Walking - remain on one's feet in an upright position at a workstation.  

• Stooping – occasional bending the body downward and forward by bending the spine at the waist - requiring full use of the lower extremities and back muscles. 

 Travel required: Less than 10%, minimal 

Required education and experience: 

• BA or BS in any science-related field 

• Minimum five (5) years’ experience in a regulated laboratory environment  

• MS degree or specialized skill set may substitute for 3 years 

• Experience in equipment services and warranty management: Previous experience in equipment services and warranty management is preferred, as it enhances the ability to manage equipment procurement, servicing, and warranties effectively.  

• Proficiency in working with laboratory equipment: Demonstrated proficiency in operating and maintaining various types of laboratory equipment is essential to perform the duties effectively.  

• Familiarity with GDP, GLP, and GMP standards: Knowledge of Good Documentation Practices (GDP), Good Laboratory Practice (GLP), and Good Manufacturing Practice (GMP) standards is to ensure compliance with regulatory requirements. 

 Preferred education and experience: 

• BA or BS in Biology, Biological Sciences, Laboratory Science, Biochemistry, or Biomedical Science/Engineering 

• Laboratory skills including more than one of the following:  microscopy, visual inspection, cell count & viability, flow cytometry, cell culture, immunoassays, DNA isolation, PCR, sterility, endotoxin, and mycoplasma 

• Experience writing GxP quality records and documentation.