Documentation Specialist Job Listing at Kelly Services in Round Lake, IL (Job ID 9510823)

Description

Summary: This position reports to the Manufacturing functional areas.
This position provides the Manufacturing documentation review. Review the batch record or any other GMP document to ensure the compliance with cGMP, Company Policies and local SOPs.
Essential Duties and Responsibilities: • Supporting manufacturing's batch documentation review.
• Responsible for ensuring manufacturing's batch records meet specifications and submitted to Quality per release schedule
• Assure batch documentation complies with GDP standards.
• Determine acceptability by using specifications and standard operating procedures.
• Ensure presence of all required documentation prior to the submission of batch folder to Quality.
• Maintain files such that documents are readily available and easily retrievable.
• Initiate and close GME work orders.
• Author Non-Conformance Records (NCRs) and Exceptions Investigations
• Author TCU documentation changes including revisions, periodic reviews and GAP assessments
• Use Maximo system to print department preventative maintenance work orders; assign and bring to completion, as necessary.
• Use SYSTECH to review and approve counts for batches.
• Initiate batch folders by performing necessary data entry.
• Support GME cycle counting as needed
• Other administrative duties as assigned.
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
• Strong computer skills in MS Office Suite.
• Knowledge of documentation systems and familiarity with batch/systems documentation preferred.
• Strong attention to detail.
• Individual will work with minimal supervision in a dynamic environment while following written procedures. Must be organized and able to prioritize tasks.
• Ability to communicate efficiently verbally and in writing with all levels of the organization.
• Identify areas for continuous improvement.
• Individual must be willing to adjust work hours and work overtime based on business needs.
• Must be able to lift 30 pounds.
• Must not be allergic to Penicillin or Cephalosporin drugs.
Education and/or Experience: Include the education and experience that is necessary to perform the job satisfactorily.
• Associates degree or 3+ years of experience in manufacturing environment and / or quality documentation.

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.

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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.

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