FLSA Classification: Non - Exempt/Hourly
Schedule: Monday to Friday; 2:00pm to 10:30pm; On-site
Department: Global Quality Operations
Reports to: Operational Quality Assurance Manager
Supervisory responsibilities: No Location: 13202 Murphy Road Suite 100 Stafford, TX 77477
Position Summary/objective: The primary purpose of this position is to perform internal audits of manufacturing/CMC procedures; track and maintain standard operating procedures, work instructions, lab notebooks, manufacturing data and perform official batch and material release.
Essential functions: - Maintaining equipment logs and files
- Tracking manufacturing numbers
- Performing internal audits of the manufacturing process
- Creating and performing internal Quality Assurance trainings for Immatics personnel
- Writing new standard operating procedures and batch records
- Keeping track of lab notebooks
- Providing support for the investigation and recall of non-conforming materials
- Writing, reviewing, and tracking deviation reports, corrective and preventive actions (CAPA) reports, maintenance reports and Out of Specification (OOS) reports
- Issuance and reconciliation of final product labels
- Certificate of Analysis (CoA) review and release for completed batches
- Review of sterility, endotoxin, and mycoplasma results
- Reagent review and release
- Initiation and completion of Change Controls for all updates to processes or documents
- Maintains electronic log of all US equipment
Competencies - Ability to make sound decisions and approach problems with curiosity and open-mindedness
- High degree of independent working, analytical reasoning, and the ability to communicate effectively
- Careful editing and documenting of results
- Ability to embrace rapidly changing requirements with an open mind and show a high degree of flexibility in an environment which is marked by a constant striving for excellence
- Ability to approach tasks in a structured, reliable, and foresighted manner; combined with a high level of individual responsibility, enthusiasm, and strong social skills
- Ability to effectively collaborate with members from other departments
Work environment: This is a sedentary position (at least 50% of time) in a typical office environment. There may be frequent interruptions with moderate noise levels and frequent use of printers, copiers, scanners, computers and other office equipment. Ability to sit, talk, walk, hear and communicate verbally and in writing is required. Occasional lifting of objects up to 25 lbs is expected.
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 No
Required education and experience - Bachelor's Degree in a Life Science Discipline is required.
- One (2-3) year experience in QA, Auditing, or clinical manufacturing in a research environment.
- At least 3-5 year of Biotechnology and/or Pharmaceutical industry experience is required.
- Experience comprehending regulations and guidance documents.
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.