Quality Compliance Associate
Location: Novato, CA.
Assignment: 7 Months (Great potential to extend)
Pay Rate: $34/hr.
On behalf of our client a leading pharmaceutical company that focuses on developing therapeutics for patients dealing with life threatening rare genetic diseases, we are seeking for a Quality Compliance Associate. The Quality Compliance Associate will play a key role in supporting quality compliance processes and ensuring adherence to regulatory standards. This temporary position, located in Novato, CA, will involve collaboration across multiple departments and focus on maintaining high standards of quality and compliance.
Key Responsibilities:
- Support quality compliance activities, including inspection readiness, self-inspection programs, data integrity initiatives, and regulatory certification efforts.
- Lead or contribute to continuous improvement efforts in quality systems, including procedures and systems, to enhance organizational effectiveness and quality assurance compliance.
- Ensure compliance with current Good Manufacturing Practices (cGMP) guidelines and procedures, escalating any non-compliance concerns to management.
- Collaborate with various departments, such as Manufacturing, Quality Control, Technical Development, and Quality Assurance, as well as external contractors.
- Interpret and apply regulatory guidelines and directives, including 21CFR, USP, EP, JP, and ICH.
- Perform other duties as assigned to support quality compliance initiatives.
Qualifications and Skills:
- Bachelor's degree (BS/BA) in a scientific discipline or related field.
- 4+ years in a biologics manufacturing environment, with prior experience in Manufacturing, Quality Control, and Quality Management System (QMS) processes.
- Excellent written, verbal, analytical, and interpersonal communication skills.
- Familiarity with cGMP, ICH, and other regulatory requirements.
