Manufacturing Specialist

Job Description

Job Description

Kelly Services is currently seeking a Manufacturing Specialist for one of our top clients in Juncos, PR .

JOB TITLE: Manufacturing Specialist
LOCATION: Juncos, PR
DURATION: 6 Months (Temporary / Contract)
PAY RATE: $38 per hour W2

JOB DESCRIPTION:
  SUMMARY
Shift: Candidates must have availability to cover different shifts.

With minimal supervision, support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions. Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems.

QUALIFICATIONS:
-Manufacturing Operation experience, (not quality)
-Document Management, create new documents, review and approval of documents.

FUNCTIONS
Applied Process Expertise
1. Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
2. Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities.
3. Provide troubleshooting support.
4. Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.

Process Monitoring:
1. Support establishment of process monitoring parameters and control limits. Collect process-monitoring data and support the assessment of deviations.

2. Provide support of timely execution of the process monitoring quarterly reports.  Non-Conformance and CAPA

1. Ensure that all Non-conformances are triaged within the established goal.
2. Responsible for authoring investigation reports.
3. Responsible for execution of corrective actions.
4. Responsible for managing NC/CAPA closure within established goal.
5. Monitor and communicate incidents trends.
6. Review equipment/system Root Cause Analysis investigations and support trend evaluations.

Process Validation
1. Assist with generation of process validation protocols and reports.
2. Assist with the execution of the process validation.
3. Support collection and analysis of process validation data.

Regulatory:
1. May participate in regulatory inspections, New Product Introductions, and Process or Equipment

Modifications:
1. Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications.
2. Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects.

Change Control:
1. Assist manufacturing change owner on CCRB packages impacting the process.

Projects and Initiatives:
1. Participate on the assessment or implementation of special projects or initiatives.
** Other functions may be assigned.

COMPETENCIES/SKILLS
-Detailed technical understanding of bioprocessing unit operations.
-Skilled in performance of GMP production operations.
-Regulatory knowledge and interactions.
-Participate and help lead cross-functional teams.
-Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality.
-Organizational, technical writing and presentation skills.
-Basic project management skills.
-Basic knowledge of control charting.

EDUCATION:
-High school/GED + 10 years of Manufacturing Operations experience
-Associates + 8 years of Manufacturing Operations experience OR
-Bachelors + 4 years of Manufacturing Operations experience OR
-Master’s + 2 years of Manufacturing Operations experience OR
-Doctorate

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® Engineering?

Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world’s most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we’re here to guide you to the next step in your engineering career.

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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