Quality Assurance Specialist
This is an onsite role that requires a member of our dedicated quality control team. As a Quality Assurance Specialist, you will be responsible for developing and maintaining quality programs, processes, and procedures that ensure compliance with established standards and agency guidelines.
Key Responsibilities:
* Perform 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).
* Write up and execute 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.
* Adhere to good laboratory practices and housekeeping standards.
* Assist in the generation and maintenance of Quality procedures and reports.
* Facilitate laboratory investigations and support associated product investigation.
Qualifications:
* Third-level qualification in Science, Engineering, or equivalent is preferred though not essential.
* 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.
Nice-to-Have:
* Experience in quality control in a biotech, pharmaceutical, or bio-pharmaceutical manufacturing environment.
* Some experience working in a QC Laboratory or production environment is preferred though not essential.
* Knowledge of computer applications, including MS Office, Excel, Laboratory Information Management System Access, and Trackwise.
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.