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.