"Alerted.org

We are seeking to identify a skilled **QA Validation Specialist (Contract)** to join a leading pharmaceutical team supporting critical **cGMP qualification and validation activities.** This **6-month contract** offers **$38–40/hr.** and hands-on ownership of equipment, facility, and laboratory validations. Ideal for experienced validation professionals who excel in regulated environments and enjoy driving projects from protocol development through audit-ready execution.

RESPONSIBILITIES:

+ Assists in assuring facility, manufacturing, packaging, and Laboratory equipment are qualified to the required cGMP standards.

+ Authors/approves and executes qualification protocols and reports.

+ Schedules, plans, manages performance qualifications, calibration and maintenance of equipment and utility systems and laboratory Instruments in coordination with operations, Quality Control and maintenance.

+ Assists sourcing and procurement of facility equipment and Laboratory Instruments through completion of following tasks

+ Qualification of Vendors Selected.

+ Input to the development of the URS/FRS/DDS.

+ Assists with the routine calibration and maintenance of the Validation Master Plan for the site.

+ May present qualification studies to Regulatory and Client Auditors as required.

+ Assists with the design, maintenance, and continual improvement of the qualification system in line with cGMP standards.

+ Provides technical expertise and guidance on qualification policies and procedures and the implementation of those within the Production and Quality functional areas.

+ Occasionally supervises specialized contract personnel and outside vendors in the performance of contract services.

+ Summarizes studies and authors qualification reports in compliance with the cGMP standards and in a timely manner.

+ Develops and executes matrix type validations where applicable for processes and equipment with adequate supporting rationales.

+ Initiates and investigates exception reports and non-conformances, associated with the qualification studies. Troubleshoots and resolves technical issues.

+ Other responsibilities and special projects will be assigned based on business and customer needs. **QUALIFICATIONS:**

+ Bachelor’s degree in Sciences

+ 5+ year’s of experience in a highly regulated pharmaceuticals industry or related field

+ Demonstrated experience with qualification of commercial processing a packaging equipment.

+ Proven track record of managing projects from start to finish on time and on budget.

+ Strong working knowledge of cGMP and regulatory standards for validation.

+ Experience in writing and reviewing SOPs, GMPs, governmental regulations and/or protocols for accuracy, traceability and compliance.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 (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) 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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s 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.