Sr. Quality Systems Engineer

Kelly Services; Salt Lake City (UT); On-site; USD 93,000 - 104,000; Full time

Job summary

Kelly Science & Clinical is seeking a Sr. Quality Systems Engineer in Salt Lake City, on-site. The role focuses on supporting QMS documentation, change control, and CGMP compliance within a pharmaceutical manufacturing environment.

The candidate should have a bachelor’s degree in a science field with 7+ years of progressive pharma experience and at least 3 years in QA. The job requires strong technical writing and cross-functional collaboration across departments.

Qualifications

• Bachelor’s Degree in science or related field with 7+ years in pharma.
• Minimum 3 years’ experience in Quality Assurance in pharmaceutical production.
• Experience with Health Authority inspections (FDA/EMA) preferred.

Responsibilities

• Support quality management systems (QMS) documentation and records.
• Lead change control activities and review boards from initiation to approval.
• Approve SOPs, protocols, risk assessments, and quality records.
• Maintain CGMP compliance across processes, equipment, and facilities.
• Collaborate with Operations, R&D, and Quality Control to drive improvements.

Skills

Quality Systems

GMP/Compliance

Change Control

SOPs & Protocols

Technical Writing

Independent Problem-Solving

Cross-Functional Communication

Senior-Level Decision-Making

Education

Bachelor’s Degree in Science

7+ years pharmaceutical experience

Quality Assurance in pharma

Tools

TrackWise

Veeva

MS Office

LMS

EDMS

ERP systems

Job description

Job Title: Sr. Quality Systems Engineer

Location : Salt Lake City, UT – This role is100% Onsite

Duration: 2 years with possible extensions

Pay: $45.00 - $50.00 based on experience

Shift Schedule: Monday–Friday, 8:00 a.m.–5:00 pm

Interview Process: Two Step Interview Process. First interview will be virtual via Microsoft Teams. Second interview will be in person, on-site, including a facility tour.

Core Essential Skills – Minimum 5 years of experience:

• Quality Systems and GMP/Compliance experience within a pharmaceutical manufacturing environment

• Change Control and Quality Documentation Management

• Review and Approval of SOPs, Protocols, Risk Assessments, and Quality Records

• Independent Problem-Solving, Sound Judgment, and Decision-Making

• Strong Technical Writing and Cross-Functional Communication Skills

• Candidates should be senior-level, independent, motivated, and comfortable making higher-level decisions.

• Experience with compliance or quality systems, documentation review and approval, and strong technical writing skills. Management experience is not required.

POSITION SUMMARY

• This position is responsible for providing support for the quality management systems (QMS), including documentation management,

• Continuous Improvement program, process, cleaning and computer system validation, equipment, facility and utility qualification.

• The role oversees Change Management, Annual Product Review, and Metrics and Data Trending. This position ensures adherence to quality standards, policies and procedures, while facilitating improvements and building a collaborative team environment among internal and external stakeholders.

• This position represents Quality Systems leadership and interacts closely with other areas such as Operations, Manufacturing Science and Technology, Research and Development, Supply Chain and Quality Control

ESSENTIAL AREAS OF RESPONSIBILITY

• Develops, supports and executes annual projects to deliver on site metrics, KPIs, goals, and other Quality / Compliance program related projects as required.

• Responsible for hosting the Change Control Review Board and overseeing change control activities from initiation through implementation and approval.

• Responsible for providing records management and change control expertise to support compliant shutdown planning and execution.

• Responsible for ensuring efficient, uninterrupted operation of the facility in accordance with requirements such as GMP, FDA, MHRA, EMEA, OSHA, EPA, DEA, etc.

• Responsible for participating in partner, internal and regulatory inspections and audits as needed.

• Responsible for reviewing and approving standard operating procedures, protocols, risk assessments and other quality records, as needed.

• Responsible for improving and maintaining quality systems to ensure compliance with CGMPs, company policies, procedures and governmental regulations.

• Supports Quality projects for accomplishment of organization goals including Corporate standard assessments, Quality project team meetings, and other cross-functional site initiatives.

• Responsible for completing all training requirements and maintaining compliance with all assignments.

• Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (CGMP), Standard Operating Procedures (SOP).

• Responsible for performing additional related duties as assigned

POSITION REQUIREMENTS

• Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.

Education/Certification/Experience:

• Bachelor’s Degree, preferably in a scientific discipline (biology, chemistry or closely related field) or equivalent education/experience with a minimum of 7 years relevant progressive experience in the pharmaceutical industry.

• Requires a minimum of 3 years’ experience in Quality Assurance within pharmaceutical production.

• Prefer direct experience with the manufacturing of various pharmaceutical dosage forms.

• Prefer direct experience with Health Authority Inspections (FDA/EMA, ANVISA, etc.)

• Project management and advanced presentation skills preferred

Skills/Knowledge/Abilities:

• Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS), EDMS and ERP systems, as well as Quality systems such as Trackwise and Veeva.

• Self-directed with ability to organize and prioritize work.

• Ability to motivate, influence and lead others with and/or without direct supervisory authority.

• Ability to positively manage conflict, provide difficult feedback and negotiate resolution.

• Ability to build and maintain collaborative relationships between teams, departments and business units.

• Ability to demonstrate sound judgment and decision making.

• Ability to communicate effectively with excellent written and oral communication skills.

• Ability to interact positively and collaborate with co-workers, management and external partners.

• Ability to analyze information and create metrics relevant to the business objectives.

• Ability to understand inter-department linkages and alignment of own department with other departments.

• Ability to drive change by identifying areas for improvement, engaging and motivating others and working through difficult transitions.

Problem Solving:

• Proactively works on problems of a complex scope where evaluation of contributing factors requires the analysis of situations or data and an in-depth knowledge and evaluation of various known and unknown factors.

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 (https://www.kellyservices.com/hubfs/myKelly/Resources/Employment_Policies/Recruitment-Artificial-Intelligence-Notice.pdf?hsLang=en) .

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