What are the responsibilities and job description for the Quality Assurance Specialist II position at BioSpace?
Location: Oceanside, CA
Schedule: Full-time (Monday–Friday; weekend/night work required during manufacturing campaigns)
Department: Quality Assurance Operations
Reports To: Sr. Manager, Quality Assurance Operations
Job Description
We are seeking a highly motivated individual to join our team as a Quality Assurance Specialist II. In this role, you will be responsible for executing a variety of quality activities to ensure compliance with applicable quality objectives and regulatory requirements. This position is based at our Oceanside, CA site.
Key Responsibilities
Master’s degree in Biological Sciences or related field
Bachelor’s degree with 2 years of relevant experience
Associate degree with 4 years of relevant experience
High School diploma with 5 years of relevant experience
Preferred Qualifications
Microsoft Word, Excel, PowerPoint
Experience With
Veeva
Smartsheet
LIMS (Laboratory Information Management Systems)
Excellent verbal and written communication skills
Ability to thrive in a fast-paced, dynamic environment and manage shifting priorities
Benefits
Full-time employees are eligible for a comprehensive benefits package, including:
Schedule: Full-time (Monday–Friday; weekend/night work required during manufacturing campaigns)
Department: Quality Assurance Operations
Reports To: Sr. Manager, Quality Assurance Operations
Job Description
We are seeking a highly motivated individual to join our team as a Quality Assurance Specialist II. In this role, you will be responsible for executing a variety of quality activities to ensure compliance with applicable quality objectives and regulatory requirements. This position is based at our Oceanside, CA site.
Key Responsibilities
- Perform Quality Assurance-related production and production support activities
- Conduct batch record review, line clearance, and provide on-the-floor QA support
- Provide QA oversight and approval of Quality Control activities, including: Method transfers Certificates of Analysis Stability programs
- Approve shipments and oversee product packaging activities
- Ensure timely assessment and closure of: Deviations CAPAs Change Controls Laboratory Investigations
- Batch and material hold events
- Communicate lot disposition and pending issues to management
- Provide QA oversight to ensure compliance with GMP standards
- Perform walkthroughs and process observations
- Support document control activities, including: Archival Updating site training records
- Assist during regulatory inspections
- Ensure products are manufactured in compliance with regulatory and GMP requirements
- Escalate issues that may impact product release timelines
- Identify compliance risks and escalate appropriately
- Generate and update procedures and forms as needed
- Perform additional duties as assigned
Master’s degree in Biological Sciences or related field
Bachelor’s degree with 2 years of relevant experience
Associate degree with 4 years of relevant experience
High School diploma with 5 years of relevant experience
Preferred Qualifications
- Background in Quality Control, including:
- Analytical testing
- Virology
- Microbiology
- Working knowledge of GMP regulations (U.S. and EU standards)
- Strong collaboration and negotiation skills
Microsoft Word, Excel, PowerPoint
Experience With
Veeva
Smartsheet
LIMS (Laboratory Information Management Systems)
Excellent verbal and written communication skills
Ability to thrive in a fast-paced, dynamic environment and manage shifting priorities
Benefits
Full-time employees are eligible for a comprehensive benefits package, including:
- Health coverage
- Life insurance
- Disability insurance
- 401(k) plan