Quality Assurance Associate
Interested in advancing biotech drug development? Integrity Bio is a great place to learn cutting edge industry skills.
Integrity Bio, Inc. specializes in biologics formulation development and drug product manufacturing. We have formulated over 200 biologics including vaccines, antibodies, proteins, and peptides for more than 150 firms. Integrity Bio specializes in hard-to-formulate products in liquid and lyophilized forms.
We are located in Camarillo and Thousand Oaks California, the center of a highly concentrated cluster of 10,000 biotech professionals. Demand for our research services increased by 30% in the past year, driving continued expansion and need for great people.
Job description
- Document control including but not limited to:
- Formatting of documents, publishing, completing change control process
- Document upload into training system and course creation
- Annual document review including generation of list of documents due, issuing and tracking completion, document revision
- Issue batch record documents
- Scanning and filing of GMP records
- Metrics- tracks and trends QA Quality Management System metrics
- Reviews and provides input for Quality Management system elements including investigations and root cause analysis
- Batch record review process: assembles and reviews all manufacturing and QCL related documents and data
- Supports Internal and Client Audits
- Supports Supplier Qualification activities
- Perform shipping verification as needed
Position Requirements
- Attention to detail and ability to consistently follow procedures
- Strong organizational skills and ability to manage multiple tasks at one time
- Demonstrated ability to work as both a team player and independently
- Excellent verbal and written communication skills; excellent interpersonal skills at all levels
- Desirable: knowledge of and ability to confirm compliance to US and EU GMP, USP, and Integrity Bio requirements
- Validation knowledge desired: software, equipment, analytical method, system Validation protocol creation, execution, and approval: Software (SQL database, Moodle platform, MS Excel, etc.), equipment, systems (facilities, etc.)
- Proficiency in MS Office
- Flexibility to travel as required for business needs (up to 10%).
- Physical Requirements
- Subject to extended periods of sitting and/or standing in an office environment
- Ability to lift 30 pounds
Education and Professional Experience
- Bachelor’s degree or minimum 1 year experience in GMP industry