QA Change Specialist in Biotech Manufacturing
Description Join a leading organization in the biotech industry dedicated to clinical and scientific research, focusing on the prevention and cure of cancer and other life-threatening diseases, guided by a patient-centered philosophy. As a QA Change Specialist, you will play an essential role in supporting clinical product and cell growth media final disposition through thorough review of manufacturing batch records and analytical testing data, ensuring compliance in a manufacturing environment. Company Culture and Environment The company prides itself on its commitment to life-saving research and fostering a culture centered around patient care and scientific integrity. Working alongside passionate professionals, you will contribute to meaningful projects that aim to improve health outcomes and enhance the quality of life. Career Growth and Development Opportunities This position offers a chance to expand your expertise in quality assurance within the biotech sector, providing valuable experience that can lead to future advancements within the organization. The company encourages continuous learning and professional growth. Detailed Benefits and Perks
- Opportunities to participate in life-saving research initiatives
- Collaborative work environment with a focus on employee well-being
- Support for continuous education and training
Compensation and Benefits
- Competitive salary based on experience
- Health, dental, and vision insurance
- Retirement savings plan options
- Generous paid time off policy
- Flexible working hours
Why you should apply for this position today This position offers a unique opportunity to make a significant impact in the biotech industry, contributing to vital research that saves lives. By joining this leading organization, you will be part of a dedicated team committed to innovation and patient care. Skills
- Strong understanding of GMP (Good Manufacturing Practices)
- Excellent attention to detail and organizational skills
- Proficient in reviewing and editing controlled documents
- Familiarity with quality assurance processes and compliance standards
- Ability to conduct audits and inspections effectively
Responsibilities
- Perform line clearances, in-process checks, label issuance, batch record issuance, and monitoring of labeling activities.
- Conduct inspection and release of incoming GMP raw materials based on specifications and standard operating procedures.
- Manage 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 implement corrective actions (CAPA).
- Ensure completion and approval of quality records by responsible personnel.
- Participate in audits and regulatory inspections as assigned.
Qualifications
- Previous experience in quality assurance or related field
- Strong background in GMP environments
- Excellent written and verbal communication skills
- Proven ability to work in a team-oriented and collaborative environment
Education Requirements
- Bachelor’s degree in a relevant scientific field (e.g., Biology, Chemistry, Life Sciences)
Education Requirements Credential Category
- Bachelor’s degree required
Experience Requirements
- Minimum of 3 years of experience in quality assurance or compliance within the biotech or pharmaceutical industry
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