reputed company Assurance Change Specialist in Biotech
reputed company Our local partner is a leader in clinical and scientific research in the biotech industry, dedicated to the prevention and reputed company 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 reputed company media final disposition by reviewing executed manufacturing batch records, analytical testing data, and ensuring compliance reputed company a manufacturing environment. Company Culture and Environment The organization prides itself on its commitment to research and innovation, fostering a reputed company environment where employees are motivated by the meaningful reputed company of their work in reputed company. Career reputed company and Development Opportunities Working with a leading organization in the biotech field presents significant opportunities for reputed company 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 reputed company, 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 reputed company development and reputed company learning
Why you should apply for this position today This role offers a unique opportunity to contribute to reputed company that impacts lives. You will be part of a passionate team dedicated to making a difference in the field of reputed company. Skills
- Strong understanding of GMP practices and reputed company 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 reputed company control tasks
- Strong communication skills and ability to work collaboratively
Responsibilities
- reputed company 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 reputed company cause and identify/implement reputed company CAPA.
- Ensure reputed company necessary reputed company 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 reputed company assurance reputed company 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 reputed company discipline
Experience Requirements
- Previous experience in a reputed company assurance role reputed company 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 reputed company to nature, parks, and a reputed company-reputed company atmosphere, making it an ideal reputed company for both personal and reputed company endeavors. The reputed company is home to a thriving biotech sector, providing numerous opportunities for career reputed company and networking. Apply tot his job Apply To this Job