Sr. Specialist, QA for Quality Control (QAV)

Job Description

Job Description

[Contract] Sr. Specialist, Quality Assurance for Quality Control (QAV)

Location: Norwood, MA (On-site)

Duration: 4 Months (with potential for extension)

Rate: Up to $70-72/hr W2 

We are seeking an experienced Sr. Specialist of QA for QC (QAV) to provide critical quality oversight for a major operational milestone: the physical move, decommissioning, and subsequent re-qualification of our Quality Control (QC) laboratory equipment across our Norwood site buildings.

While our internal execution teams will handle the hands-on decommissioning, commissioning, qualification, and validation (CQV) tasks, you will be the final line of defense. Your primary focus will be the rigorous review and approval of all documentation ensuring data integrity, compliance, and total equipment readiness.

This is a fast-paced, high-impact 4-month contract ideal for a sharp validation QA professional who thrives in a dynamic GMP environment.

We are looking for a specialist who can jump in on Day 1 without a steep learning curve. The ideal candidate brings:

• Education: Bachelor’s degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or a related scientific field.

• Experience: 3 to 8 years of solid CQV/Validation experience within a biotech, biopharma, or highly regulated GMP environment—ideally with a direct background in Quality Assurance or Quality Control.

• Technical Familiarity: Deep understanding of analytical or microbiological QC testing instruments, method validation, and method transfer.

• Digital Quality Systems: Proficiency with modern digital quality platforms—Kneat experience is highly preferred, alongside familiarity with change control and deviation software.

• Regulatory Knowledge: solid working knowledge of FDA, EU, and ICH guidelines.

Responsibilities

What You’ll Do

As the Quality Assurance anchor for this project, you will ensure every logbook, protocol, and change control meets stringent cGMP standards. Your daily responsibilities will include:

• CQV Document Review: Review and approve qualification/validation protocols, final reports, periodic reviews, instrument forms, and data tables to ensure equipment is compliant and ready for use.

• Quality System Oversight: Identify, assess, and approve deviations, change controls, CAPAs, and work orders tied directly to the instrument relocation and setup.

• Data Integrity & GDP: Audit QC logbooks and ensure all execution teams are strictly adhering to Good Documentation Practices (GDP) and Data Integrity guidelines.

• Compliance Leadership: Make real-time quality decisions to keep the project aligned with FDA, EU, and ICH regulations, as well as internal SOPs and work instructions.

• Quality Assurance
• Quality Control
• Lab Equipment
• CQV

Qualifications
• Years of experience: 5 years
• Experience level: Experienced

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At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact View email address on ziprecruiter.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.