Quality Assurance Change Specialist in Biotech
Description Our local partner is a leader in clinical and scientific research in the biotech industry, dedicated to the prevention and cure of cancer and other life-threatening diseases. Guided by a patient-centered philosophy, this organization is committed to saving lives through science. As a QA Change Specialist, you will support clinical product and cell growth media final disposition by reviewing executed manufacturing batch records, analytical testing data, and ensuring compliance within a manufacturing environment. Company Culture and Environment The organization prides itself on its commitment to research and innovation, fostering a collaborative environment where employees are motivated by the meaningful impact of their work in healthcare. Career Growth and Development Opportunities Working with a leading organization in the biotech field presents significant opportunities for professional development and career advancement as you contribute to groundbreaking work. Detailed Benefits and Perks While specific benefits are not listed, joining a leading organization in the biotech industry typically comes with competitive compensation packages, opportunities for growth, and a chance to contribute to life-saving research.
Compensation and Benefits
- Competitive salary based on experience
- Comprehensive benefits package, including health and wellness programs
- Opportunities for professional development and continuous learning
Why you should apply for this position today This role offers a unique opportunity to contribute to vital research that impacts lives. You will be part of a passionate team dedicated to making a difference in the field of healthcare. Skills
- Strong understanding of GMP practices and quality assurance principles
- Excellent attention to detail and analytical skills
- Capability to write and review controlled documents in compliance with regulatory requirements
- Proficient in performing inspections and quality control tasks
- Strong communication skills and ability to work collaboratively
Responsibilities
- Perform line clearances, in-process checks, label issuance, batch record issuance, monitoring of labeling activities, cell bank control and issuance, and final product control.
- Conduct inspection and release of incoming GMP raw materials according to specifications and SOPs.
- Execute document change control activities.
- Write, edit, and review controlled documents to ensure compliance with regulatory requirements.
- Prepare and maintain training and competency files.
- Write and review investigations and product complaints to determine root cause and identify/implement related CAPA.
- Ensure all necessary quality records are completed and reviewed/approved by responsible personnel.
- Participate in audits and regulatory inspections as assigned.
Qualifications
- Bachelor’s degree in a relevant scientific field or equivalent experience
- Experience in quality assurance within a manufacturing environment is preferred
- Knowledge of regulatory requirements applicable to the biotech industry
Education Requirements
- Bachelor’s degree in a relevant scientific field
Education Requirements Credential Category
- Degree in Life Sciences or related discipline
Experience Requirements
- Previous experience in a quality assurance role within a biotech or pharmaceutical setting is preferred
- Familiarity with GMP regulations and practices
Why work in Duarte, CA Duarte, CA, offers a welcoming community with access to nature, parks, and a close-knit atmosphere, making it an ideal place for both personal and professional endeavors. The city is home to a thriving biotech sector, providing numerous opportunities for career growth and networking. Apply tot his job Apply To this Job