Operational Quality Assurance Specialist II

Immatics; Stafford (TX); On-site; USD 60,000 - 85,000; Full time

Job summary

A leading biopharmaceutical company, Immatics, is looking for an Operational Quality Assurance Specialist II to support quality assurance operations. The role involves conducting internal audits and ensuring compliance with regulatory standards while contributing to innovative cancer immunotherapy solutions.

Benefits

Health, Dental, and Vision Insurance

Paid Time Off

401(k) plan participation with match

Flexible Leave Options

Professional Growth Opportunities

Qualifications

• 2-3 years experience in QA, Auditing, or clinical manufacturing.
• 3-5 years in Biotechnology/pharmaceutical industry.
• Experience with regulations and guidance documents.

Responsibilities

• Conduct internal audits of manufacturing and CMC procedures.
• Track and maintain critical documentation.
• Oversee and execute batch and material release activities.

Skills

Analytical reasoning

Effective communication

Problem-solving

Attention to detail

Education

Bachelor’s Degree in a Life Science Discipline

Job description

Operational Quality Assurance Specialist II

Join to apply for the Operational Quality Assurance Specialist II role at Immatics

Operational Quality Assurance Specialist II

Join to apply for the Operational Quality Assurance Specialist II role at Immatics

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Senior Talent Acquisition Specialist Immatics US, Inc.

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

Immatics is at the forefront of immunotherapy innovation, working to harness the power of T cells to transform cancer treatment.

Immatics is an exceptional clinical-stage biopharmaceutical company active in the discovery and development of T cells redirecting cancer immunotherapies. We use these powerful T cells to develop groundbreaking immunotherapies that target cancer cells. We are dedicated to transforming cancer treatment and improving patient outcomes through cutting-edge research and advanced TCR technology.

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 an Operational Quality Assurance Specialist II to join our Operational Quality Assurance team. In this role, the specialist will be responsible for conducting internal audits of manufacturing and CMC (Chemistry, Manufacturing, and Controls) procedures, ensuring compliance with regulatory and company standards. The position also involves tracking and maintaining critical documentation such as standard operating procedures, work instructions, lab notebooks, and manufacturing data. Additionally, the specialist will oversee and execute official batch and material release activities, supporting overall quality assurance operations.

FLSA Classification: Hourly, Non-Exempt

Schedule: 0800 – 1630; Monday to Friday; On-site

Reports to: Senior Manager, Operational Quality Assurance

Location: 13203 Murphy Road Suite 100 Stafford, TX 77477

What You’ll Do:

As an Operational Quality Assurance Specialist II, you will play a key role in supporting our batch and material release:

• Maintaining equipment logs and files
• Tracking manufacturing numbers
• Performing internal audits of the manufacturing process
• Writing audit reports
• 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

Required Experience and Education:

• Bachelor’s Degree in a Life Science Discipline is required.
• 2-3 years experience in QA, Auditing, or clinical manufacturing in a research environment.
• At least 3-5 years of Biotechnology and/or pharmaceutical industry experience is required.
• Experience comprehending regulations and guidance documents.
• 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

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.

• 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

• 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, up to 100K (club together)
• 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 paidParental Leave for eligible employees. (3 weeks)
• Additional voluntary employee paid coverage 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.

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance, Manufacturing, and Research

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Paid maternity leave

Paid paternity leave

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