Berkeley HeartLab, Inc is a rapidly growing leader in the emerging market segment of advanced blood testing for heart disease. Our unique, patented technology is foundation of a complete disease management solution utilized by physicians across the United States. We are headquartered in Burlingame, CA. This is an excellent opportunity to join a fast growing health care leader.
Position: Manager of Quality Control
Position Summary:
Support the timely release of Gels and Buffers through testing, manufacturing support and process validations. Directs tests and validations for new or changing processes. Develop and direct procedures and inspection methodology for processes, procedures, materials, manufacturing equipment and test fixtures.
Management has ultimate responsibility for demonstrating Berkeley HeartLabs commitment to quality by ensuring the quality policy is established, communicated, and understood and relevant to the organization, regulatory requirements, policies, procedures and the products or services provided to customers and employees. Management has the authority to provide adequate resources to effectively implement quality, continuous improvement and customer satisfaction.
Responsibilities and Key Duties:
1. Documentation and validation of all processes in the manufacture of testing components.
2. Validation of new production systems.
3. Validation in scale up of new production machinery and process
4. Inspects all materials involved in the manufacture and test of product of components.
5. Maintains inventory records and reconciles movement of materials.
Education:
1. 4 year degree or equivalent required
Experience and Training:
1. Medical Diagnostic industry experience a must
2. Hands on experience in a laboratory environment
3. Experience of the QSR/GMP/GLP regulations
4. Minimum 2 years experience as a QC Manager. Knowledge of a Clinical Laboratory setting a plus.
5. Experience in both traditional and start-up environments.
Special Knowledge Skills and Abilities:
1. Goal driven, persistent achiever who likes a challenge
2. Able to work well in a high pressure environment
3. Takes direction well and can handle multiple tasks effectively
4. Strong written, verbal and organizational skills
5. Computer literate
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