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Kelly Science & Clinical is seeking a Manufacturing Specialist near Juncos, PR.

6 month contract

Shift: Monday - Friday 8am-5pm, needs to be flexible

Compensation: $38/hr

SUMMARY

We are seeking a dynamic and detail-oriented Manufacturing/Quality Systems Specialist to join our team. With minimal supervision, you will support the execution of various manufacturing and quality systems including non-conformances, process validation, procedures, training, and new product introductions. You will apply your process, operational, scientific expertise, and basic compliance knowledge to support manufacturing operations. As a primary production process owner, you will play a crucial role in ensuring the efficiency and quality of our manufacturing processes.

ROLE AND RESPONSIBILITIES

Applied Process Expertise

• Initiate, revise, and approve manufacturing procedures ensuring they reflect current operations accurately.

• Assess process performance through floor operations observation and performance data review, implementing process improvement solutions where needed.

• Provide expert troubleshooting support.

• Assist in generating and possibly delivering training materials on scientific or technical process aspects.

Process Monitoring

• Establish and monitor process parameters and control limits, collecting and assessing process-monitoring data.

• Support timely execution and reporting of process monitoring quarterly reports.

Non-Conformance and CAPA

• Ensure timely triage of all non-conformances.

• Author thorough investigation reports.

• Execute corrective actions and manage NC/CAPA closure within established timelines.

• Monitor, communicate, and evaluate incident trends.

Process Validation

• Aid in the creation and execution of process validation protocols and reports.

• Collect and analyze process validation data.

Regulatory Compliance

• Potential participation in regulatory inspections.

New Product Introductions & Process/Equipment Modifications

• Participate in the NPI process, assessing documentation, materials, training, and equipment modification requirements.

• Manage and support process or equipment modification projects.

Change Control

• Assist as a manufacturing change owner on CCRB packages impacting the process.

Projects and Initiatives

• Participate in the assessment or implementation of special projects or initiatives.

Other tasks as assigned.

EDUCATION AND EXPERIENCE REQUIREMENTS

• Doctorate degree OR

• Master's degree with 3 years of manufacturing operations experience OR

• Bachelor's degree with 5 years of manufacturing operations experience OR

• Associate’s degree with 10 years of manufacturing operations experience OR

• High school diploma / GED with 12 years of manufacturing operations experience.

COMPETENCIES AND SKILLS

• In-depth technical understanding of bioprocessing unit operations.

• Proficient in GMP production operations.

• Knowledgeable in regulatory compliance and interactions.

• Competent in cross-functional team collaboration and leadership.

• Exceptional communication and collaboration skills with technical and management staff.

• Strong organizational, technical writing, and presentation skills.

• Basic project management and control charting knowledge.

Join our team and contribute to the success and innovation of our manufacturing operations. We offer a collaborative and engaging work environment where your expertise will be valued and your professional growth supported.

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 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. 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.