Quality Systems Specialist Job Listing at Kelly Services in Lebanon, PA (Job ID US3569421_BH9851480)

Description

Kelly® Science & Clinical is seeking Quality Systems Specialist for a contract-to-hire position at a pharmaceutical packaging leader in Lebanon, PA.  If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Compensation: $28.00/hr
Schedule:  M-F, 1st shift (8A-5P)
SUMMARY
Provide administration and oversight regarding the quality systems. Work in collaboration with various department system stakeholders to ensure quality systems conform to regulations and quality policies and standards. Help ensure and address adherence to cGMP processes, while aiding the quality team and other key contacts.  Support the achievement of department Key Performance Indicators (KPIs) and overall site objectives and deliverables.

RESPONSIBILITIES

• Assist management team in understanding global requirements regarding quality systems
• Serve as site Subject Matter Expert (SME) for defined quality systems
• Manage the Change-Control process and metrics reporting
• Manage the CAPA and SCAR processes, to include, issuing, reviewing, approving and performing effectiveness checks and metrics reporting
• Manage the non-conformance process and metrics reporting
• Develop, coordinate, and lead quality systems governance and oversite meetings
• Engage with key stakeholders and site management to ensure timely closure of quality actions
• Support, develop and deliver technical and/or compliance training
• Identify and address compliance gaps across quality systems
• Generate and revise Standard Operating Procedures (SOPs) and associated documents, as needed; work within the scope of all applicable SOPs
• Identify compliance risks and raise such issues to appropriate management contacts
• Manage assigned CAPA(s) by performing root cause investigations, while defining resolution actions; implement preventative and corrective actions in a timely manner as a result of customer complaints or customer audit findings
• Ensure execution of global CAPAs, while confirming effectiveness
• Complete trend analysis for quality data
• Help in customer audits and inspections conducted by regulatory organizations, as needed
• Work on special projects, as assigned
• Participate in required trainings and meetings, when necessary
• Follow all Company policies and procedures
• Cross train in other Quality areas and/or functions to support business needs
• Help promote and implement safety/EHS directives and maintain a clean and safe workspace
• Follow cGMP and adhere to all ISO and safety guidelines, policies and protocols

QUALIFICATIONS

1. High School Diploma or GED, required
2. Bachelor's Degree in Business Administration, Life Sciences, Communications or Engineering, highly preferred
3. Minimum 3 years of experience in a Quality related manufacturing role
4. Experience working in a fast-paced manufacturing setting
5. Solid knowledge of ISO 9001, 13485 and 15378, and cGMP
6. Thorough knowledge and usage of MS Office and SAP
7. P#1

Send resumes to Jacqueline.Sayoc@KellyScientific.com
 

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 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.

 Apply on company website