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FLSA Classification: Non-Exempt/Hourly
Schedule: Second Shift 12:00 PM – 8:30 PM; Monday to Friday; On-site
Department: Quality Control
Reports to: Associate Manager Quality Control
Supervisory responsibilities: No
Locations: Primary- 13203 Murphy Road Stafford TX 77477; Secondary- 2201 W Holcombe Blvd. Houston TX 77030
Position Summary/objective:
The main role of the Quality Control Analyst is to execute bio-analytical, molecular, microbiological, and/or cell-based assays to support the release of Immatics Drug Products.
Essential functions:
- Conduct and document all activities consistent with cGMP/GxP, regulatory filings, and written procedures.
- Execute bio-analytical, cell-based, microbiological and/or molecular methods for product release in the Quality Control laboratory.
- Safely handle human biological specimens.
- Perform basic laboratory calculations, e.g. cell count/concentration, viability, dilutions.
- Extract, compile, and analyze data.
- Generate, report, and track results.
- Review and approve in-process Quality Control data, change controls, deviations, and test results for timely disposition of cell therapy products for human clinical use.
- Author or implement changes to controlled documents (e.g., specifications, methods, SOPs, etc.) and processes.
- Perform instrument/software/assay qualifications and validations.
- Maintenance of data integrity and equipment logs.
- Perform routine equipment maintenance and troubleshooting.
- Manage, in collaboration with other team members, supply inventory.
Competencies:
- Very detail oriented.
- Strong analytical, technical writing, verbal communication, and interpersonal skills.
- Collaborates effectively with coworkers and between departments.
- Flexible and able to perform under pressure to meet project timelines.
- Self-directed and can work with limited direction in a fast-paced environment.
Work environment:
- Position is for Second Shift, M-F 12:00pm – 8:30pm.
- Shift differential pay is effective after 5:00pm.
- Occasional weekend work/support may be required to support GMP operations.
- Two laboratory locations currently in use.
- Secondary location to be closed Q3 2024.
- Handling of human biological specimens including human peripheral blood and human T cell products.
- 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 building could involve exposure to manufacturing operations, along with outdoor conditions and temperatures.
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 a life science related field.
- One (1) year in a cGMP/GxP regulated Biologics or Pharmaceutical laboratory environment. (MS degree may substitute for this experience.)
- Experience with molecular techniques such as DNA Isolations, PCR, RT-PCR.
Preferred education and experience:
- Two (2) years in a cGMP/GxP regulated Biologics or Pharmaceutical laboratory environment.
- Experience with cGMP/GxP QC testing.
- Experience with cGMP/GxP quality documents.
- Experience with cGMP/GxP qualifications or validations.
- Experience with cell culture techniques, cell-based assays, or flow cytometry.
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.”
Other duties:
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. This job description may not cover all duties that take place on a daily basis and may be changed as business needs change. Employee will be responsible for adapting and learning the duties as described above or as the new ones are introduced.
