Senior Quality Control Analyst

Reposted 10 Days Ago
Be an Early Applicant
Houston, TX
In-Office
Senior level
Information Technology • Biotech
The Role
The Senior Quality Control Analyst will perform bioanalytical, cell-based, and molecular assays, lead quality documents, collaborate on testing, and ensure compliance in the laboratory.
Summary Generated by Built In

Join Immatics and shape the future of cancer immunotherapy; one patient at a time 

 

Immatics is committed to making a meaningful impact on the lives of patients with cancer. We are the global leader in precision targeting of PRAME, a target expressed in more than 50 cancers. Our cutting-edge science and robust clinical pipeline form the broadest PRAME franchise with the most PRAME indications and modalities, spanning TCR T-cell therapies and TCR bispecifics. 

 

Why Join Us? 

  • Innovative Environment: Help to pioneer advancements in cancer immunotherapy. 

  • Collaborative Culture: Be part of a diverse team dedicated to your professional growth. 

  • Global Impact: Contribute to therapies that make a lasting impact on patients globally. 

 

We are seeking a Senior Quality Control Analyst to join our Global Quality Operations team. In this role, the Senior Quality Control Analyst will be responsible for performing bioanalytical, cell-based, and molecular assays to support product release and stability testing within the Quality Control laboratory. The position will also play a key role in method transfer, qualification, and validation activities. 

 

FLSA Classification: Salary, Exempt  
Schedule: 8:00 AM – 5:30 PM; Monday to Friday; On-site  
Reports to: Quality Control Manager  
Location: 13203 Murphy Road Suite 100 Stafford, TX 77477  

 

What You’ll Do: 

As a Senior Quality Control Analyst, you will play a key role in supporting our Quality Control Operations:  

Training Coordination and Collaboration 

  • Coordinate and manage team training activities in partnership with crossfunctional team members. 

  • Oversee the Quality Control training program to ensure all required training is scheduled, tracked, and completed. 

  • Organize, maintain, and archive training documentation in compliance with internal and external requirements. 

  • Support the design, development, and implementation of training curriculum to enhance team competency and performance. 

Testing and Analysis 

  • Perform routine and nonroutine testing on products and materials to verify compliance with established specifications and standards. 

  • Analyze complex data sets, identify trends and deviations, and take initiative to investigate and troubleshoot issues. 

Cross Functional Collaboration 

  • Collaborate with team members to manage purchasing, receiving, formulation, testing, and release of materials and reagents. 

  • Support equipment and assay qualification activities, including validation and periodic review. 

Quality Records Management 

  • Lead the creation, management, and closure of quality records, including GxP deviations, laboratory investigations, OOS/OOE events, CAPAs, and change controls. 

Documentation 

  • Author, revise, and conduct periodic reviews of procedures and controlled documents. 

  • Document all activities in accordance with cGMP/GxP standards, regulatory requirements, and internal procedures. 

  • Maintain data integrity and complete accurate equipment logs and records. 

Equipment Management 

  • Perform and oversee routine maintenance, calibration, and qualification of laboratory equipment to ensure operational readiness. 

Compliance 

  • Participate in developing and maintaining Quality Control systems to ensure alignment with regulatory and industry standards. 

  • Ensure all work practices meet regulatory, corporate, and departmental compliance requirements. 

Safety 

  • Consistently demonstrate safe laboratory practices and promote a strong safety culture within the team. 

Secondary Functions:

  • Transport controlled documents, QA-released QC materials and human biological samples.   

  • Assist with tasks scheduling  

  • Maintain knowledge of internal procedures and current regulatory requirements 

Required Experience and Education: 

  • BA or BS in any science-related field   

  • Four (4) years of experience in a regulated laboratory environment   

  • MS degree or specialized skill set may substitute for 1 year   

  • Experience performing QC activity in a related field.   

  • Experience developing training material for GxP Quality Control processes. 

Preferred Experience and Education: 

  • MS in Biology, Biological Sciences, Laboratory Science, Biochemistry, or Biomedical   

  • Science/Engineering   

  • Five (5) years of experience in a regulated laboratory environment  

  • Laboratory skills include a few of the following: visual inspection, flow cytometry and cell counting. 

  • Molecular and cell-based assays.  

  • Qualification/Validation activities  

  • Technical writing and troubleshooting/investigational skills.  

  • Knowledge of cGMP/ICH/EU regulations and requirements.  

  • Experience with LIMS. 

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 lab environment with moderate noise   

  • levels and uses phone, computer, office equipment and supplies on a regular basis.  

  • Other duties performed while outside of office and lab building could involve   

  • exposure to manufacturing operations, along with outdoor conditions (including highway traffic) and temperatures.   

  • The percentage of working hours spent in a typical office and/or laboratory. 

  • Environment varies based on business needs.  

  • While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts, fumes or airborne particles, pathogens, and toxic or caustic chemicals. The employee can be occasionally exposed to wet and/or humid conditions, risk of electrical shock, sharps, or cuts, while performing tests.  

  • This position requires handling of human biological specimens including human peripheral blood and human T cell products, as well as laboratory chemicals. 

Travel required: Less than 10% Minimal 

 

 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. 

 

Work authorization/security clearance requirements: 

 Legal eligibility to work in the United States is required. Immatics participates in E-Verify and all new employees will be subject to the Department of Homeland Security requirements for employment . 

 

Affirmative Action/EEO statement: 

 Immatics is an equal opportunity employer. All employment decisions including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, national origin,  

ethnicity, marital status, age, physical or mental disability, medical conditions, pregnancy, genetic  information, gender, sexual orientation, gender identity or expression, veteran status, or any  other status protected under federal, state, or local law. 

 

What do we offer? 

 At Immatics, we believe in investing in our team’s health, safety and well-being. Here’s what you can expect if you join Immatics 

 

Comprehensive Benefits:  

  • Competitive rates for Health, Dental, and Vision Insurance 

  • 4 weeks of Paid Time off, granted up front each year and prorated for first and last year of employment. 

  • Sick Time Off  56 hours  

  • 12 Paid Holidays  

  • 100% Employer-Paid Life Insurance up to at 1x annual salary 

  • 100% Employer Paid Short- and Long-Term Disability Coverage  

  • 401(k) with Immediate Eligibility  & company match… 

  • You are eligible for 401(k) plan participation as of your first paycheck. 

  • The company will match 100% of your contributions up to 3% of your base salary for the first two years of employment, 4% for years 2-3 of employment, and up to 5% of your salary from the fourth year onward of continued employment. 

  • Partially paid Parental Leave for eligible employees. (3 weeks) 

  • Additional voluntary employee paid coverages including  Accident, Hospital Indemnity, and Critical Illness Employee Paid Identity Theft Protection and Pet Insurance 

 

Professional Growth:  

  • Opportunities to work with leading experts in the field of T-cell immunotherapy. 

  • Company provided learning and development opportunities 

  • Fast paced, high demand collaborative and dynamic environment. 

Top Skills

Cell-Based Assays
Cgmp
Flow Cytometry
Gxp
Molecular Assays
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The Company
Houston, , Texas
550 Employees
Year Founded: 2000

What We Do

Immatics combines the discovery of true targets for cancer immunotherapies with the development of the right T cell receptors with the goal of enabling a robust and specific T cell response against these targets. This deep know-how is the foundation for our pipeline of Adoptive Cell Therapies and TCR Bispecifics as well as our partnerships with global leaders in the pharmaceutical industry. We are committed to delivering the power of T cells and to unlocking new avenues for patients in their fight against cancer.

Read more about Immatics on our homepage: https://immatics.com/

Find us also on:
Twitter: https://twitter.com/immatics
Instagram: https://www.instagram.com/immatics/
YouTube: https://www.youtube.com/channel/UCv7uTpsGXvSNzwSX_xOtYSA

Legal notice: https://immatics.com/imprint/

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