Investigator Job Listing at Kelly Services in Malvern, PA (Job ID US3588009_BH9910445)

Description

Investigator
Kelly Services is currently seeking an Investigatorfor one of our top clients in Malvern, PA.  

• Work as primary investigator / Specialist to ensure consistent quality standards are maintained.
• Collaborate with QA to initiate, author and drive to a timely completion NC investigations in the Comet System.
• Work with team to identify true root cause of investigations, assess product quality impact, and approve investigations as management technical representative, as needed.
• Provide recommendations and implement corrective/preventative measures aimed at improving compliance and reducing repeat occurrences, following up to determine if corrective actions adequately addressed root cause of NC event.
• Track deviations, events and key process parameters and provide reports to management on trending, and status as requested, recommending corrective actions for any trends identified, and collaborate with management to review and approve events and deviations.
• Act as a SME to customers, providing guidance on deviations, investigations, and issues pertaining to quality of product.
• Identify and implement process improvements within the change control system and related to safety, environmental, quality, compliance, productivity, yield, and cost, partnering with all Cells and COE s as applicable.
• Develop business cases for projects and present to site leadership for approval. Initiate and execute change controls for projects and work with management to allocate group resources to assist with change control, equipment startup, and technical training, assuring regulatory compliance and technical feasibility of proposed changes.
• Serve as project manager for the change process and provide coordination to ensure timely and compliant implementation of process improvements.
• Share best practices between production sites and assist with equipment startup and technical training as required.
• Provide technical support concerning the change control system and for process and cleaning validation maintenance and verification and assist with cleaning cycle optimization and revalidation efforts.
• Serve as a SME during internal and external regulatory audits including FDA, EMA .
• Extract process data from SCADA and Delta-V servers for use in databases maintained by technical operations and utilize database to monitor process performance and proactively troubleshoot operations.
• Work with Automation and Information Management to improve the effectiveness of process data collection and analysis.
• Coordinate data collection and trend analysis as requested by QA and Regulatory Affairs including the annual report required for maintenance of the Statistical Quality Control Database SQC and the Annual Product Review APR.
• Demonstrate expertise in a number of the following areas: cGMPs, FDA regulations, cell banking, formulations, Cell culture, chromatographic purification, ultrafiltration, microfiltration, diafiltration, viral inactivation, filter integrity testing, CIP/SIP systems, or pharmaceutical water systems and utilities.
• Provide documentation support for SOP/ Batch Record revisions, identify and communicate necessary document changes to document management group to ensure timely revision to all SOP and batch records and review and approve SOP and Batch record revisions a

Important information: This position is recruited by a remote Kelly office, not your local Kelly branch.  Applicants must be legally permitted to work in the United States.
  Why Kelly® The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG®) is one focus within the full array of Kelly Services® workforce solutions.
Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.
The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.
As a Kelly Services employee, you will have access to numerous perks, including:

• Vacation and sick pay
• Paid holidays
• 401(k) plan
• Group medical, vision, dental, life, and short-term disability insurance options
• Kelly Discounts on goods and services, auto and home insurance, and tuition at Kelly partner schools
• Kelly Learning Center offers free courses and trainings
• Weekly pay

  About Kelly Services® As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.


 

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® 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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