Quality Assurance Change Specialist in Biotech Research
Description Our local partner is a leader in clinical and scientific research in the biotech industry. The company takes pride in their research behind the prevention and cure of cancer and other life-threatening diseases, guided by a patient-centered philosophy. Join a leading organization that is dedicated to saving lives through science! Company Culture and Environment The work environment is centered around collaboration and a strong commitment to patient care. Employees are encouraged to contribute to groundbreaking research that can save lives, fostering a sense of purpose and community. Career Growth and Development Opportunities Working with a leading organization in the biotech field presents numerous opportunities for professional development and career advancement as you contribute to meaningful projects. Detailed Benefits and Perks While specific benefits are not detailed, being part of a leading organization typically offers a comprehensive benefits package, including health and wellness resources.
Compensation and Benefits
- Competitive salary based on experience
- Health and wellness programs
- Opportunities for professional development Why you should apply for this position today This role offers a unique opportunity to make a difference in the biotech industry and contribute to lifesaving research. By joining this organization, you will be part of a team that is dedicated to innovation and excellence in clinical research. Skills
- Attention to detail in reviewing and analyzing data
- Knowledge of GMP and regulatory requirements
- Strong organizational and documentation skills
- Proficient in writing and reviewing controlled documents
- Ability to perform inspections and ensure compliance Responsibilities
- Perform line clearances, in-process checks, label issuance, and batch record issuance.
- Monitor labeling activities, cell bank control and issuance, and final product control.
- Inspect and release incoming GMP raw materials per specifications and procedures.
- Conduct document change control activities.
- Write, edit, and review controlled documents for regulatory compliance.
- Prepare and maintain training and competency files.
- Write and review investigations and product complaints for root cause determination.
- Ensure completion and approval of all necessary quality records.
- Participate in audits and regulatory inspections as assigned.
Qualifications
- Experience in quality assurance or related field
- Familiarity with GMP regulations
- Strong analytical and problem-solving skills
- Excellent communication and interpersonal abilities Education Requirements
- Bachelor’s degree in a relevant scientific field or equivalent experience. Education Requirements Credential Category
- Relevant scientific discipline or equivalent professional certification. Experience Requirements
- Minimum of 2 years of experience in a quality assurance role within a biotech or pharmaceutical environment.
- Proven experience with GMP processes and regulatory compliance. Why work in Duarte, CA Duarte offers a unique blend of suburban charm and proximity to the vibrant city of Los Angeles. Known for its commitment to healthcare and research, Duarte provides a supportive environment for professionals in the biotech industry, with access to numerous cultural, recreational, and educational opportunities.
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