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SalaryIt's fun to work in a company where people truly BELIEVE in what they're doing!
We're committed to bringing passion and customer focus to the business.
FLSA Classification: Non-Exempt/Hourly
Schedule: Monday-Friday 2nd Shift: 1230 -2100
Weekends and holidays as needed
Fully Onsite
Department: CMC
Reports to: CMC-GMP Sr. Manufacturing Manager
Supervisory responsibilities: No
Location:
Avery - 2201 W Holcombe Blvd. Suite 205 Houston, TX 77030
Weatherford - 13203 Murphy Rd. Stafford, TX 77477
UTHealth Science Center- 1941 East Rd, BBSB 6102 Houston, TX 77054
Position Summary/objective:
The primary purpose of this position is to procure, organize, maintain and control the materials required for cGMP manufacturing.
Essential functions:
- Creates and follows SOPs and procedures for incoming receipt, quarantine/release processes, supply ordering, inventory control and material kitting as appropriate.
- Performs critical inventory tasks to ensure the correct quantity of items are stocked at all times.
- Analyze inventory numbers and prepare documents for supply ordering.
- Monitors and manages expired, obsolescent, and non-conforming material inventory and assist in relevant investigations.
- Creates and follows supply chain policies, procedures, techniques, standards, and systems.
- Develops and performs operations of Materials Management including assembly of kitted components.
- Transports materials to and from research and cGMP facilities.
- Prepares and receives domestic and international temperature-controlled shipments.
- Track PM and equipment calibration dates and assist with routine equipment maintenance.
- Maintain accurate documentation in compliance with FDA’s Good Laboratory Practices, Good Manufacturing Practices, Good Tissue practices, as well as standards set by other accreditation agencies including but not limited to FACT, CAP, and CLIA.
Secondary functions:
- Provide input or feedback regarding change controls, WI, and SOPs as directed.
- Ability to provide information and feedback for study plans, reports, deviations, OOS/OOE, and CAPA’s as directed.
- Provides feedback on inventory status and quantities and assists in any modifications
- Reviews BR updates or change controls, WI, and SOPs as needed.
- Provides improvement/ troubleshooting ideas as needed.
- Provides assistance with OOS/OOE reports when necessary.
Competencies
- Independent Working- routine tasks with limited supervision; non-standard tasks with close supervision.
- Communication- clear and efficient verbal and written communication; common courtesy; interaction mainly limited to own team (peers and supervisor)
- Problem Solving- ability to identify, deeply analyze and communicate problems; basic ability to develop suitable solutions.
- Critical Thinking- basic reflection on standard processes; identification of basic need and room for improvement within own or narrow scope.
- Initiative- high degree of initiative and intrinsic motivation to exceed basic expectations of own tasks and responsibilities.
- Organizational & Prioritization Skills- basic organization skills required to structure own daily tasks according to predefined work packages, schedule and standard lab processes; prioritization in close interaction with supervisor.
- Coachability- receive pre-defined trainings essential for area of responsibility; high responsiveness to constructive criticism and basic ability to autonomously reflect on required improvements; timely implementation of suggested improvements.
- Leadership Skills, Training & Supervision- basic leadership skills required for on-the-job trainings and guidance/support of (new) team members (e.g. providing and receiving feedback, empathy, honesty, reliability); train, instruct and coordinate E level; train D & C level during onboarding
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.
While performing the duties of this job, the employee routinely handles blood components and is occasionally exposed to temperatures between 37°C to -196°C, liquid nitrogen, liquid nitrogen vapor, dry ice, and carbon dioxide.
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.- Feeling- the ability to detect different materials or temperatures with fingers and hands
- Gowning- sitting or standing to don or remove sterile PPE
- Hearing – the ability to hear, understand, and distinguish speech and/or other sounds one-on-one, group or conference, telephone, and other sounds.
- Lifting - raising or lowering an object (up to 50 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).
- Undergo a color blindness evaluation and assessment of vision abilities required for this position
- Pushing - Exerting force upon an object so that the object moves away from the object. Must be able to push carts and gas tanks on rolling wheels (approximately 50 lbs).
- Pulling - Exerting force upon an object so that the object moves toward the force. Must be able to pull carts and gas tanks on rolling wheels (approximately 50 lbs.)
- Reaching- Extending both hands and/or arms perpendicular to the floor and in front of your body towards an object for extended periods of time.
- Sitting – remaining in a sitting position for up to 50% of the time.
- Standing/Walking - remain on one's feet in an upright position at a workstation up to 50% of the time.
- 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.
- Typing – 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.
Travel required: Travel may be required between the office building and manufacturing facility on a daily basis.
Required education and experience
- High School Diploma/GED
- Two (2) to four (4) years of Materials Management/supply chain experience
- Experience working in a manufacturing and/or GMP facility
- Working knowledge and understanding of GMP, GCP, GDP, and relevant ICH and FDA guidelines
- Cold chain supply knowledge and experience in a pharmaceutical or biotech setting
Preferred education and experience
- Bachelor’s Degree in related field preferred
- Four (4) years of Materials Management/supply chain experience preferred.
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.
Valid driver’s license and criminal background check.
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.
