Mastech Digital provides digital and mainstream technology staff as well as Digital Transformation Services for all American Corporations. We are currently seeking a Manufacturing Assurance Specialist for our client in the Biotech domain. We value our professionals, providing comprehensive benefits and the opportunity for growth. This is a Contract position, and the client is looking for someone to start immediately.
Duration: 6+ Months Contract
Location: Vista, CA
Salary: $40.00-$50.00/Hourly
Role: Manufacturing Assurance Specialist
Primary Skills: Engineering
Role Description: The Manufacturing Assurance Specialist must have 5+ years of experience. Seeking a detail-oriented Investigation Specialist to support manufacturing operations by leading deviation investigations, identifying root causes, and ensuring effective corrective and preventive actions (CAPA) in a regulated (cGMP) environment.
Key Responsibilities:
- Investigate manufacturing deviations, environmental monitoring excursions, and calibration issues
- Perform root cause analysis and assess impact on product and production
- Collaborate with Manufacturing, Quality, Facilities, QC, and QA teams to resolve issues
- Generate clear, compliant investigation reports with corrective/preventive actions
- Support CAPA, change control, and documentation management (DCM) activities
- Review manufacturing, facilities, and environmental monitoring records to support investigations
- Conduct facility and utility inspections and report potential risks
- Ensure compliance with regulatory and industry standards
Requirements:
- Hands-on experience in manufacturing, validation, or aseptic processing
- Strong technical writing, analytical, and problem-solving skills
- Experience with CAPA, deviation investigations, and root cause analysis
- Familiarity with cGMP, FDA regulations, and quality systems
- Proficiency in MS Office and systems such as SAP, LIMS, or DCM
- Ability to work independently in a fast-paced, regulated environment
Work Environment:
- Cleanroom environment (gowning required)
- 24/7 plant operations ? flexibility for shifts required
- Ability to lift/push up to 40 lbs and manage multiple priorities.
Education: Any
Experience: Minimum 5+ years of experience
Relocation: This position will not cover relocation expenses
Travel: No
Local Preferred: Yes
Note: Must be able to work on a W2 basis (No C2C)
Recruiter Name: Veena Grover
Recruiter Phone:
Benefits:
We have various coverages and additional benefits to choose from:
- Medical, Dental (Including Ortho) & Vision Insurance (Option to Enroll).
- Paid Leaves (Wherever applicable).
- Life & Disability Coverage (Upon eligibility).
- 401K Option, Education Assistance Program and more.
Mastech Digital is an Equal Opportunity Employer - All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Minimum Education Required: Bachelor
Years of Experience Required: More than 5 years
Expected Travel Time: None
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