QA Validation Specialist

SPECTRAFORCE; Sanford (NC); On-site; USD 89,544 - 111,585; Full time

Job summary

A leading pharmaceutical firm is seeking a QA Validation Specialist in Sanford, NC. The role focuses on the implementation and assessment of quality systems to ensure compliance with regulatory standards. The ideal candidate will have a relevant degree, substantial experience in quality assurance, and a solid understanding of FDA and EMA guidelines. This contract position requires hands-on QA support and the ability to work collaboratively in a fast-paced environment, with a competitive pay range of $65 to $81 per hour.

Qualifications

• 3-5+ years of experience in a QA function in biologics manufacturing.
• Experience with qualification/validation of process equipment and analytical instruments.
• Strong understanding of FDA and EMA regulations.

Responsibilities

• Provide QA support and oversight ensuring compliance with quality standards.
• Review approval for qualification/validation documents and deviations.
• Author and approve controlled documents like SOPs and protocols.

Skills

Quality Assurance

Analytical skills

Communication skills

Problem-solving

Education

B.S. degree in Biological/Physical/Chemical sciences or engineering

M.S. degree in relevant field

Job description

Position Title

QA Validation Specialist

Work Location

Sanford, NC 27330

Assignment Duration

11 months

Work Schedule

8 AM - 4:30 PM

Work Arrangement

Onsite 4 days a week (5 days preferred; most team works 1 day remote)

Base Pay Range

$65.00/hr - $81.00/hr

Position Summary

The Specialist, QA Validation will be primarily responsible for the implementation, execution and assessment of quality systems, procedures, and records to support compliant GMP operations. This position works closely with Validation, Engineering, Manufacturing, Quality Control, Facilities, and Automation.

Key Responsibilities

• Provide hands‑on QA support and oversight to internal staff and suppliers/contractors to ensure compliance with local and global quality standards, regulatory requirements, and industry guidance.
• Provide QA review and approval for commissioning/qualification/validation documents.
• Provide QA review and approval of qualification and validation deviations and discrepancies, and support investigation and corrective actions.
• Author, review and approve controlled documents for the Quality organization including SOPs, specifications, protocols, and reports.

Qualification & Experience

• B.S. degree in Biological/Physical/Chemical sciences, engineering, or equivalent focus of study and 3‑5+ years of experience OR M.S. degree and 1‑3+ years of experience in a QA function in a biologics manufacturing facility.
• Experience with qualification/validation of process equipment, analytical instruments, clean utilities, automation, sterile filling, and clean facilities.
• Strong understanding of FDA, EMA, local regulations and guidelines, ICH guidelines, and industry best practices.
• Successful history working in a fast‑paced team environment, meeting deadlines, and prioritization of work from multiple projects.
• Strong analytical and communication skills as well as sound judgment, with the ability to work effectively with others.
• Excellent problem‑solving skills and experience with root cause investigations and CAPA determination.
• Off hours coverage and flexibility may be required.

Seniority Level

Mid‑Senior level

Employment type

Contract

Job function

Quality Assurance

Industries

Pharmaceutical Manufacturing