Job Description:
We are seeking a highly skilled QA Compliance Specialist to join our team. This is an initial 12-month contract role.
Responsibilities:
* Evaluate and ensure that all products manufactured meet the required standards for marketed and investigational drug products.
* Provide quality oversight during the aseptic processing of products, including intervention observation and review of completed batch records.
* Lead investigations arising out of product or manufacturing processes non-compliance.
* Review and audit operations documentation, including SOPs, JSTMs, risk assessments, and line clearance activities.
* Perform incoming raw material checks and provide stability program support.
* Ensure finished product status maintenance, including labeling as required.
* Administer quality logs, QA holds, and sample requests.
* Conduct daily walk-around inspections of manufacturing areas to drive continuous improvements and simplify site processes.
Required Skills and Qualifications:
* Bachelor's degree in a science, quality, or engineering discipline.
* Minimum three years' experience in a quality/operations role in a highly regulated GMP environment.
* Strong knowledge of regulatory requirements.
Benefits:
This role offers a unique opportunity to work in a highly regulated environment and contribute to the success of our organization.
Others:
Please submit your application with a detailed resume and cover letter.