Senior Specialist, Quality Control (Change Control Lead)

Randstad USA; Norwood (MA); On-site; USD 107,000 - 117,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

401K plan

Vision benefits

Job summary

Randstad USA is seeking a Senior Specialist, Quality Control (Change Control Lead) in Norwood, MA. This onsite role focuses on owning the GMP change control process and collaborating with QC leadership to ensure robust impact assessments and reliable quality standards.

As the site scales operations with new ASUs, you will contribute to strategic execution, risk mitigation, and continuous improvement. Moderate- to high-visibility position with fast-paced manufacturing support and mentorship

Qualifications

• BS/BA in Life Sciences, Engineering, Regulatory, or related discipline.
• 5–8 years in pharmaceutical/biotech sector.
• Hands-on GMP change controls lifecycle experience.
• Proactive problem-solver under pressure in fast-moving lab/manufacturing environments.
• Strong GDP and Data Integrity knowledge.

Responsibilities

• Own the QC change control process from initiation through implementation and closure.
• Represent QC Operations on Change Control Boards and cross-functional forums.
• Support documentation and lifecycle management for clinical and commercial specifications.
• Anticipate risks, prioritize under pressure, and develop mitigation strategies during growth.
• Lead process improvements, streamline templates, and support SOPs/method documentation.

Skills

Quality Control

Change Control

GMP

Technical Writing

Education

BS/BA in Life Sciences

Job description

Exciting Career Opportunity | Make a Meaningful Impact in Quality Control

Are you an experienced Quality Control professional who thrives in a collaborative, mission-driven environment? If you love taking ownership of vital systems, solving complex challenges, and being the go-to expert who keeps critical projects moving forward, this role was built for you!

Quick Snapshot:

• Role: Senior Specialist, Quality Control (Change Control Lead)
• Location: Norwood, MA (Onsite — collaborative, high-energy environment)
• Pay Range: $78.00 – $85.00/hour (Up to $90.00/hour for exceptional experience)
• Type: 6-Month Contract with high visibility and growth momentum
• Schedule: Standard Day Shift (No rotating shifts!)
• NO C2C

About the Opportunity

Randstad, in partnership with our client, is seeking a collaborative, forward-thinking Senior Specialist, Quality Control to serve as a pivotal partner to QC leadership.

As the site expands its footprint, introduces new Automated Storage Units (ASUs), and scales operations, our Quality team is growing rapidly. You will step in as the true co-owner of the GMP Change Control process, ensuring seamless strategic execution, robust impact assessments, and reliable quality standards.

Here, your voice matters. You will work alongside passionate scientists, engineers, and quality leaders who celebrate innovation, continuous learning, and direct mentorship.

What You’ll Be Doing

• Own the Process: Drive the strategic development, governance, and end-to-end execution of QC change controls from initiation through implementation and closure.
• Be the SME: Represent QC Operations on local and global Change Control Boards and cross-functional forums.
• Champion Specifications: Support documentation and lifecycle management for clinical and commercial specifications (experience with specifications is a huge plus!).
• Navigate Fast-Paced Growth: Anticipate risks, prioritize under pressure, pivot quickly as volume ramps up, and partner across teams to build effective mitigation strategies.
• Continuous Improvement: Spearhead process enhancements, streamline templates, and support technical writing for SOPs, methods, and controlled documentation.

What You Bring

• Education: BS/BA in Life Sciences, Engineering, Regulatory, or a related discipline.
• Experience: 5–8 years within the pharmaceutical or biotechnology sector.
• Change Control Expertise: Proven hands‑on experience driving GMP change controls through complex lifecycles (experience handling changes for specifications is highly desirable).
• Agility & Drive: A proactive problem‑solver who remains composed under pressure and enjoys dynamic, fast‑moving laboratory and manufacturing support environments.
• GxP Knowledge: Strong foundation in GMP, Good Documentation Practices (GDP), and Data Integrity standards.

Why You’ll Love Working Here

You’ll be joining a team that values human connection, direct collaboration, and purposeful work. Our in‑person culture ensures you are closely supported, continuously learning, and directly contributing to products that make a real difference in patients' lives.

Interested in learning more? Apply today or connect directly to discuss how your experience fits this growing team!

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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 [e-mail].

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.