Quality Control Supervisor Job Listing at Kelly Services in Montgomery, NJ (Job ID US3581829_BH9891814)

Description

Senior Consultant – QC, Analytical and QA Position Summary:
Support GMP operations in compliance with FDA, EU, and other international regulations. The consultant will play a key role in establishing QC procedures, managing raw material testing, and ensuring timely release of materials, intermediates, and finished products.
This role will focus heavily on raw material testing, sample scheduling, and leading laboratory investigations (OOS/OOT/OOE) under cGMP. Key Responsibilities:

• Author and revise technical documents including:
  • Standard Operating Procedures (SOPs)
  • Test Methods
  • Method Validation Protocols and Reports
  • Material Specifications
  • IOQ Protocols for laboratory equipment/instrumentation
• Manage and schedule sample testing activities, with a primary focus on raw materials.
• Support the implementation and integration of Empower Chromatography Data System (CDS).
• Lead investigations for OOS (Out-of-Specification), OOT (Out-of-Trend), and OOE (Out-of-Expectation) results in compliance with cGMP.
• Troubleshoot analytical issues during method transfer and method validation studies.
• Establish and maintain a robust stability testing program.
• Participate in internal and external GMP audits and provide QC support.

Required Skills & Experience:

• Bachelor's or advanced degree in Chemistry, Biochemistry, Biotechnology, or a related scientific field.
• Minimum 5–7 years of relevant industry experience in an FDA-regulated pharmaceutical or biotechnology company.
• Hands-on experience with raw material sampling in a cleanroom environment is essential.
• Proficient in analytical techniques including:
  • HPLC, GC, TOC, FTIR, Raman spectroscopy
  • Karl Fischer, osmolality, melting point, optical rotation
  • Wet chemistry compendial methods (USP/EP)
• Strong working knowledge of USP/EP, cGMP, and EU GMP requirements.
• Demonstrated ability in technical writing and document authorship.
• Experience with instrument and equipment validation, including IOQ documentation.
• Proven ability to lead investigations and troubleshoot analytical issues effectively.
• Exceptional communication, organizational, and collaboration skills.

Preferred Qualifications:

• Experience with Empower CDS implementation or administration.
• Prior involvement in establishing or maintaining stability programs.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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