FLSA Classification: Non-Exempt/Hourly
Schedule: Monday to Friday; (Second Shift 12:00pm - 8:30pm)
Department: Quality Control
Reports to: Associate Quality Control Manager
Supervisory responsibilities: No
Locations: 13203 Murphy Road Stafford TX 77477; UTH - 1941 East Rd. Houston TX 77030
GxP position: Yes
Position Summary/objective: The main role of the Quality Control Analyst is to execute bio-analytical, cell-based, and/or molecular methods for product release in the Quality Control laboratory.
Essential functions: - 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.
- Conduct and document all activities consistent with cGMP/GxP, regulatory filings, and written procedures.
- Transport human biological samples between manufacturing facility and QC laboratory.
- Transport controlled documents between OQS office and QC laboratory.
- Transport QA-released QC materials between QC laboratories.
- Manage, in collaboration with other team members, supply inventory.
- Assist with purchasing, receiving, formulating, testing, and release of materials and reagents.
- Perform routine equipment maintenance and troubleshooting.
- Maintain data integrity and logs for equipment.
Secondary Functions: - Assist with quality documents and processes such as GxP deviations, lab investigations, OOS/OOE, CAPAs, change controls, etc.
- Involved in the creation of systems used in quality control to maintain compliances with regulations.
Competencies: - Initiative- high degree of initiative and intrinsic motivation to exceed basic expectations of own tasks and responsibilities; pro-active contribution to development of the team structure and lab processes (beyond own tasks)
- Problem Solving- ability to identify, deeply analyze and communicate problems; advanced ability to develop and pro-actively propose suitable solutions.
- Independent Working- minimal supervision of routine tasks; limited supervision of non-standard tasks and manage multiple projects with aggressive timelines.
- Organizational & Prioritization Skills- intermediate organization skills required to structure own daily tasks according to predefined work packages, the manufacturing schedule and standard lab processes; good understanding of priorities within own/narrow scope; prioritization requires limited interaction with the manager.
- Strong analytical, technical writing, verbal communication, and interpersonal skills
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.
- 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.
- This position requires local travel in personal vehicle on the public roads between sites in the Houston area.
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.
- Manual Pipetting - using one's dominant hand, wrist, and thumb to dispense small amounts of liquids using micropipettes.
- Biosafety Cabinet work - holding both arms out extended from the body for the duration of performing aseptic techniques.
Travel required: Required education and experience: - BA or BS in a life science related field.
Preferred education and experience: - BA or BS in Biology, Biological Sciences, Laboratory Science, Biochemistry, or Biomedical Science/Engineering
- Experience in a laboratory environment
- Experience in cellular manufacturing and/or process development or in related biological or biochemical applications
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.