Quality Assurance Consultant

Oxford Global Resources; Berkeley (CA); On-site; USD 99,000 - 129,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Life Insurance

Disability

401(k)

Paid holidays

Paid sick leave

Accommodation

Job summary

Oxford Global Resources seeks a Quality professional to perform tactical document review across API and drug product used in Phase 1-3 studies. Responsibilities include reviewing manufacturing records, change controls, investigations, and analytical data, plus approving test methods and validation reports.

You will also manage batch disposition and ensure compliance within a cross-functional team. The role requires 5+ years in Quality for pharma/medical devices, strong CAPA and RCA knowledge,

Qualifications

• Experience in small molecule manufacturing and contract manufacturing.
• Minimum 5+ years' work experience in Quality within Medical Device/Pharma.
• Knowledge of CAPA, Root Cause Investigation, Validation (Process, Test Method, Software, Design).
• Familiar with Environmental Monitoring, Manufacturing operations, etc.
• Excellent verbal and written communication skills and cross-team collaboration.

Responsibilities

• Review and approve manufacturing records, change controls, investigations and analytical data.
• Review and approve test methods and method validations.
• Review manufacturing validation protocol and reports.
• Document and batch disposition of API and drug product used in clinical studies.
• Interact with all levels of management with professional assertiveness.

Skills

CAPA knowledge

Root Cause Investigation

Validation (Process)

Validation (Test Method)

Environmental Monitoring

Manufacturing operations

Quality systems

Analytical skills

Communication skills

Project management

Collaboration with management

Education

Bachelor's degree in Engineering

Job description

Summary

Perform tactical work and review a variety of documents, protocols, and reports.

Project Details

• Exhibit varying levels of experience and a solid progression of work and/or training
• Document, review and batch disposition of API and drug product used in Phase 1-3 clinical studies
• Review and approve manufacturing records, change controls, investigations and analytical data
• Review and approve test methods and method validations
• Review manufacturing validation protocol and reports

Job Experience

• Experience in small molecule manufacturing and contract manufacturing
• Bachelor's degree in Engineering, Chemistry, Biology, or other related discipline
• A minimum of 5+ years' work experience in the Quality organization of a Medical Device and/or Pharmaceutical company
• Knowledge and experience in CAPA; Root Cause Investigation; Validation (Process, Test Method, Software, and Design); Environmental Monitoring, Manufacturing operation, etc.
• Excellent verbal and written communication skills
• Demonstrate ability to effectively collaborate and partner with all levels of management while maintaining an appropriate assertive style is critical
• Strong analytical skills
• Effective project management and organizational skills are essential
• Knowledge and understanding of quality
• Manufacturing processes and procedures, planning, supply chain, inventory management

Hourly Rate: 72-94

Oxford is an Equal Employment Opportunity Employer. All qualified applications will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.

Oxford will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.

Oxford provides supplemental medical (we do not offer major medical), dental, vision, life, and disability benefit plans along with a 401(k) Retirement Savings Plan.

Paid holidays based on eligibility and paid sick leave for applicable jurisdiction, as required.

Oxford is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities.

If you need special assistance or an accommodation while seeking employment, please email [e-mail].

We will make a determination on your request for reasonable accommodation on a case-by-case basis.