Quality Assurance Specialist

We are currently seeking a Full-Time

Quality Assurance Specialist

to support our global team. This position will work in Houston, Texas. Your analytical reasoning and action-oriented style as well as your organization and communication skills will contribute to the team’s success.

Job Overview

The primary purpose of the QA Specialist position is to perform internal audits of Manufacturing/CMC and QC procedures; track and maintain SOPs, Work Instructions, and Manufacturing trends; perform Batch Record preparation, issuance, and review, as well as batch release; issue controlled labels and forms; track and trend deviations, OOS, change controls, and CAPA; maintain and review equipment files and logs as well as SDS, CoA, and chemical and biological lists; perform QA-relevant training and maintain training files for all employees; and maintain employee job descriptions and CV.

Overall Responsibilities

Your main responsibilities will include but are not limited to the following tasks:

  • Direct supervisor for the Program Management team.
  • Ensure the development and implementation of a comprehensive strategic portfolio plan to support corporate objectives.
  • Implement product development and lifecycle management planning.
  • Successful and timely completion of the Project Management team goals.
  • Lead contingency planning.
  • Maintain SDS, CoA, Chemical Lists.
  • Track Manufacturing Numbers.
  • Maintain Equipment Logs and Files.
  • Internal Audits of Manufacturing Process.
  • Write Audit Reports.
  • Write new SOPs and Batch Records.
  • Keep track of lab books.
  • Provide support for the investigation and recall of non-conforming materials.
  • Perform batch record preparation, issuance and verification.
  • Issuance of controlled labels and forms.
  • Other activities as may be assigned.

Qualification

  • REQUIRED: Bachelor’s Degree Biotechnology, Biology, Microbiology or in a Life Science Discipline.
  • A minimum of 1-3 years of experience in QA or clinical manufacturing in a research environment
  • 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.
  • Dedication to innovation and science.
  • Must have reliable transportation
  • Ability to approach tasks in a structured, reliable and foresighted manner; combined with a high level of individual responsibility, enthusiasm and strong social skills.

We expect a high degree of independent working, analytical reasoning and excellent communication skills. You embrace rapidly changing requirements with an open mind, think outside the box and show a high degree of flexibility in an environment which is marked by a constant striving for excellence. You approach tasks in a structured, reliable and foresighted manner, combined with an elevated level of individual responsibility, enthusiasm and strong social skills.

What We Offer

We are a committed and inspired team and cherish the collegial, highly motivated and family-friendly atmosphere within Immatics. Our culture allows for a high level of originality, independent thinking and initiative. We believe in supporting our employees’ professional and social skills. Immatics offers partial subsidized health, dental and vision insurance, 401(k), 160 hours of PTO annually, paid holidays, paid parking, paid short/long term disability/AD&D and life insurance, and stock options.

If you’re interested in working for Immatics, please forward you CV along with a letter of introduction via e-mail to RecruitingUS@immatics.com. For more detailed information about Immatics and privacy protection visit www.immatics.com.

Job Posting: Quality Assurance Specialist (all genders welcome)

Notice to Third-Party Recruiters/Staffing Agencies: Recruitment is managed through Immatics US’ Human Resources department. Resumes will only be accepted from staffing agency/recruiters if there is a signed contract in place. Recruiters are requested to not contact our hiring managers or employees directly to inquire about open positions or to present candidates. In the event a staffing agency/third-party recruiter submits a resume without a contract in place, the candidate submitted will be considered unsolicited and treated as if the candidate submitted their resume directly to Immatics US, and no fee/payment will be paid. Recruiters interested in working with Immatics US can submit their information to HR-US@imamtics.com, and we will contact you if needed.