Senior QA Specialist - Quality Systems

Job Description

Job Description

Senior Quality Assurance / Quality Systems Consultant

Kelly Science & Clinical is seeking an experienced Senior Quality Assurance / Quality Systems professional for an onsite contract opportunity with a leading life sciences organization in Gaithersburg, MD .

Job Details

• Job Title: Senior Quality Assurance / Quality Systems Consultant

• Location: Gaithersburg, MD

• Work Arrangement: Onsite

• Contract: 3–6 months initially

• Schedule: 40 hours per week

• Shift: Day Shift

• Pay Rate: $70–$85/hour

• Employment Type: Contract

• Supervisory Responsibilities: None

Position Overview

Kelly Science & Clinical is seeking a highly experienced Senior Quality Assurance / Quality Systems professional to support a broad range of quality and compliance activities within a regulated life sciences environment.

The ideal candidate will have 8+ years of experience in Quality Assurance and Quality Systems and a strong background in quality systems, supplier quality, audits, CAPA, change controls, and regulatory readiness.

This opportunity is appropriate for candidates ranging from Senior QA to Senior Manager QA level . While the role requires a high level of expertise and independent decision-making, there are no direct supervisory responsibilities .

Key Responsibilities

• Review and close change controls , including client notifications associated with change controls.

• Assess and approve CAPAs and effectiveness checks.

• Review and approve documents within the eQMS , including:

  • Validation documentation

  • Risk assessments

  • SOPs

  • QC specifications

  • Method validations

  • Facility validations

  • EMPQ

  • APS

  • Other quality and validation documentation

• Conduct and/or support supplier quality audits .

• Review and approve supplier change notifications related to Supplier Quality.

• Conduct internal audits and review associated responses.

• Review and complete assessments of supplier-initiated notifications , including evaluation of potential product impact.

• Support FDA readiness activities , including compiling gap assessments and working with cross-functional teams on remediation efforts.

• Provide Quality support for additional projects and initiatives as needed.

Qualifications

• 8+ years of experience in Quality Assurance and/or Quality Systems.

• Experience within a GxP-regulated pharmaceutical, biotechnology, medical device, or life sciences environment .

• Strong knowledge of Quality Systems, including CAPA, change control, audits, supplier quality, and document management .

• Experience reviewing and approving validation and quality documentation .

• Experience with supplier quality and supplier audits .

• Experience supporting FDA readiness, inspections, or regulatory gap assessments .

• Strong understanding of applicable FDA/GxP requirements and quality regulations .

• Excellent written and verbal communication skills.

• Ability to work independently and collaborate effectively with cross-functional teams.

• Candidates with experience ranging from Senior QA through Senior Manager QA are encouraged to apply.

• No people-management responsibilities are associated with this position.

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As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type. 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.

Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice.