Immatics US is currently seeking a Quality Assurance Specialist to join our team to perform internal audits; track and maintain SOPs, Work Instructions, and Manufacturing numbers; perform Batch Record preparation, issuance, and verification; perform official batch release.
QUALITY ASSURANCE SPECIALIST
- Conduct internal audits at LSP and GMP.
- Write audit reports.
- Provide consultation and/or advice in alignment with QA policies.
- Assist with the development and oversight of the quality systems program.
- Troubleshoot and aid in the resolution of non-conformances, deviations and CAPA follow ups.
- Create, update and maintain employee training plans. Evaluate staff for competency of role assigned on an annual basis. Conduct training as needed.
- Conduct release and closure reviews of product history records for accuracy and completeness to ensure adherence to organizational policies and procedures.
- Assist with vendor qualifications.
- Assist with complaint investigations.
- Maintain SDS, CoA, chemical lists.
- Keep track of new employee CV, job description.
- Write and review new SOPs and BRs.
- Provide support for the Investigation and Recall of non-conforming materials.
- Perform Batch Record preparation, issuance, and verification.
- Issuance of Controlled Labels and Forms.
Qualifications and Requirements
To be considered for this position, applicants must meet the following requirements:
- 3 to 5 years of quality assurance experience in biologics.
- Experience with cell culture and aseptic technique.
- BA/BS in scientific discipline or related field.
- Strong knowledge of cGMP’s for pharmaceuticals/biotechnology.
- Must have excellent oral, written and interpersonal skills.
- Ability to learn and adapt in a fast-paced and dynamic work environment.
- Ability to work independently and as part of a team, with a proven ability to effectively plan and organize work activities and prioritize task completion to adhere to schedules and deadlines.
- Ability to handle multiple assignments and changing priorities.
Other Skills & Abilities
This position will collaborate with QC, Manufacturing, Logistics, and Clinical Operations to ensure quality-related activities are executed fully.
Immatics US, Inc. is a highly innovative biopharmaceutical company headquartered in Houston, TX (USA) and co-launched, together with MD Anderson Cancer Center, as a subsidiary of Immatics Biotechnologies GmbH, headquartered in Germany. We are a clinical-stage biopharmaceutical company active in the discovery and development of T-cell redirecting immunotherapies for the treatment of cancer.
Our transformative product candidates are - best in class - Adoptive Cell Therapies and Bispecific TCR molecules. These products are directed against tumor targets that have been identified and validated by Immatics' proprietary and world-leading XPRESIDENT® technology.
Our mission is to bring the power of T-cell redirecting immunotherapies to cancer patients with more than 100 targets covering 20 major solid and liquid tumors with 80% of the discovered targets being novel. We have 2 proprietary technology platforms and 8 proprietary development programs, with 2 in the clinical trial phase as of 2017.
The US has a team of over 40 highly qualified research, medical and business professionals and we are looking for team members who constantly strive for excellence and whose motivation is driven by their dedication to innovation and science.