Manufacturing Assurance Specialist

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: 412-525-7995

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.