Job Title: Quality Assurance Specialist - Pharma
Location: San Jose, CA (On-site)
Employment Type: Contract
Job Responsibilities:
- Investigate manufacturing deviations and support CAPA management.
- Conduct root cause analysis and implement corrective and preventive actions.
- Review GMP batch records and manufacturing documentation.
- Identify and address quality compliance gaps and audit findings.
- Maintain inspection-ready documentation and support FDA inspection readiness.
- Collaborate with QA and Manufacturing teams on remediation activities.
Required Qualifications:
- Minimum 3 years of experience in pharmaceutical or biopharmaceutical Quality Assurance.
- Hands-on experience with deviations, CAPAs, and root cause investigations.
- Experience reviewing GMP batch records and quality documentation.
- Knowledge of GMP requirements and FDA compliance.
- Strong documentation, investigation, and problem-solving skills.
Pay Scale - Anticipated hourly pay range: $38/hr to $42/hr (W2), depending on experience (DOE).
Benefits - Employees hired into this position are eligible for the following benefits, subject to applicable plan terms and eligibility requirements:
- Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for the full cost of their insurance premiums.
- Retirement Benefits: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.
- Paid Time Off (PTO): No PTO other than that required by applicable state and local laws.