**Quality Assurance Specialist**
We are seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of the quality control team, you will be responsible for developing and maintaining quality programs, processes, and procedures that ensure compliance with established standards and agency guidelines.
You will be a subject matter expert in procedures, techniques, tools, materials, and equipment. You will adapt standard methods and procedures by applying your knowledge, prior work experience, and requirements.
Key responsibilities include:
* Performing analysis of quality control samples including raw materials, in-process, intermediates, stability, and finished products in line with Current Good Manufacturing Practices (part of GxP).
* Writing up and executing Analytical Method Transfer Exercises for products being transferred to the site, ensuring compliance with site, Pfizer Quality Standards (PQS), International Conference on Harmonization guidance, and Filing requirements.
* Adhering to good laboratory practices and housekeeping standards.
* Assisting in the generation and maintenance of Quality procedures and reports.
* Facilitating laboratory investigations and supporting associated product investigation.
* Analyzing both wet chemistry and the use of analytical equipment including but not limited to UV, HPLC, FTIR, KF, iCE, ICP, CE, and compendial assays.
**Qualifications:**
* A third-level qualification in Science, Engineering, or equivalent is preferred though not essential.
* A strong knowledge of analytical techniques both theoretical and practical.
* Excellent interpersonal and communication skills.
* Detail-oriented, quick at decision making, self-motivated with good troubleshooting and problem-solving abilities.
We encourage applicants who possess experience in quality control in a biotech, pharmaceutical, or bio-pharmaceutical manufacturing environment. Knowledge of computer applications, including MS Office, Excel, Laboratory Information Management System Access, and Trackwise, is also desirable.
This job description indicates the general nature and level of work expected of the incumbent. It is not designed to cover or contain a comprehensive listing of all activities, duties, or responsibilities required of the incumbent. Incumbents may be asked to perform other duties as required.