What are the responsibilities and job description for the Quality Assurance Validation Specialist position at BioPhase?
QA Process Validation Specialist – BioPhase
Department: Quality Assurance
📍 Location: San Diego (Fully Onsite)
💰 Salary Range: $80,000 - $88,000
Job Summary:
BioPhase is seeking a QA Process Validation Specialist to support pharmaceutical manufacturing processes in a highly regulated environment. This role involves developing and maintaining validation documentation, ensuring compliance with industry regulations, and collaborating with cross-functional teams to support process improvements. The ideal candidate will have a strong background in quality assurance, process validation, and regulatory requirements.
Key Responsibilities:
- Process Validation Documentation: Draft, review, and approve validation protocols and reports to ensure compliance with established procedures and regulatory standards.
- Process Monitoring & Risk Assessment: Conduct periodic reviews of validated processes, including statistical analysis and risk assessments (e.g., FMEA).
- Cross-functional collaboration: Work closely with manufacturing, quality, and process development teams to ensure the successful implementation of validation activities.
- Cleaning Validation & Equipment Qualification: Assist in maintaining cleaning validation programs and reviewing related documentation.
- Regulatory Compliance: Ensure all validation activities align with cGMP, FDA, and other applicable regulatory guidelines.
- Continuous Improvement: Support process optimization initiatives and contribute to the enhancement of validation strategies.
Qualifications:
🎓 Education & Experience:
- Bachelor’s degree in Chemistry, Biochemistry, Engineering, or a related field.
- Minimum 5 years of experience in pharmaceutical manufacturing, process validation, or a regulated industry.
🔬 Skills & Competencies:
- Strong knowledge of cGMP, FDA, and EU regulatory requirements for pharmaceutical manufacturing.
- Experience with statistical analysis tools and risk management methodologies.
- Excellent organizational and communication skills with the ability to manage multiple projects.
Work Environment & Additional Information:
- 🏢 Fully onsite position in San Diego.
- Office and cGMP manufacturing environment requiring personal protective equipment when necessary.
- Ability to work in a fast-paced setting while ensuring compliance with quality standards.
Salary : $80,000 - $88,000
