QA Records Specialist

Kelly

Melrose Park (IL)

On-site

USD 33,000 - 39,000

Full time

3 days ago
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Benefits offered by this job

medical
dental
vision
telemedicine
term life
whole life
accident insurance
critical illness
a legal plan
short-term disability
a retirement savings plan
service bonus and holiday pay plans (8
paid holidays per benefit year)
a transit spending account
paid sick leave under state/local plan

Job summary

Kelly in Melrose Park, IL is seeking a QA Records Specialist to manage quality and production documentation, including Master Batch Records, packaging records, testing specs, and lab records, ensuring audit-ready, accurate records to support scheduled production.

The role coordinates production batches, reviews records for accuracy, communicates discrepancies, maintains batch documentation, and supports training of new staff. Assignment is 3 months with potential extension or conversion.

Qualifications

  • Undergraduate degree preferred in Chemistry, Biology, Life Sciences, or a related field; equivalent experience may be considered.
  • 3-5 years of experience in the pharmaceutical, biotechnology, medical device, manufacturing, or other regulated industry preferred.
  • Strong written and verbal communication skills.
  • Excellent attention to detail and organizational skills.
  • Ability to manage multiple priorities and meet deadlines.
  • Computer proficiency and ability to learn new software systems.
  • Experience working with controlled, technical, or quality documentation preferred.

Responsibilities

  • Coordinate scheduled production batches and ensure required documentation is available.
  • Review batch records and production data for accuracy and completeness.
  • Identify and communicate missing information or documentation discrepancies.
  • Prepare, issue, reconcile, and maintain batch and quality records.
  • Support documentation for protocols, special studies, and component qualifications.
  • Attend production scheduling meetings and monitor changing production requirements.
  • Maintain organized, audit-ready records according to company procedures.
  • Assist with training new QA Records Specialists.
  • Perform other duties as assigned by QA Documentation/MQA management.

Skills

Microsoft tools
Organization
Software exposure

Education

Undergraduate degree preferred in Chemistry, Biology, Life Sciences, or related field; equivalent experience may be considered.

Tools

Quality systems software
Document management systems
ERP platforms
Databases

Job description

Pay Rate

Pay Rate: $24.50/hour

Schedule: Monday-Friday, 8:00 AM-5:00 PM

Location: Onsite - Melrose Park, IL

Assignment: 3 months, with potential extension or conversion based on business needs and performance

Job Summary

The QA Records Specialist manages and maintains quality and production documentation, including Master Batch Records, packaging records, testing specifications, and laboratory records. This role ensures records are accurate, complete, organized, and available to support scheduled production.

  • Coordinate scheduled production batches and ensure required documentation is available.
  • Review batch records and production data for accuracy and completeness.
  • Identify and communicate missing information or documentation discrepancies.
  • Prepare, issue, reconcile, and maintain batch and quality records.
  • Support documentation for protocols, special studies, and component qualifications.
  • Attend production scheduling meetings and monitor changing production requirements.
  • Maintain organized, audit-ready records according to company procedures.
  • Assist with training new QA Records Specialists.
  • Perform other duties as assigned by QA Documentation/MQA management.
Requirements
  • Undergraduate degree preferred in Chemistry, Biology, Life Sciences, or a related field; equivalent experience may be considered.
  • 3-5 years of experience in the pharmaceutical, biotechnology, medical device, manufacturing, or other regulated industry preferred.
  • Strong written and verbal communication skills.
  • Excellent attention to detail and organizational skills.
  • Ability to manage multiple priorities and meet deadlines.
  • Computer proficiency and ability to learn new software systems.
  • Experience working with controlled, technical, or quality documentation preferred.
Top 3 Skills
  • Microsoft: Proficiency with Word, Excel, Outlook, and Teams.
  • Organization: Ability to prioritize tasks, manage records, and meet deadlines.
  • Software Exposure: Experience with quality systems, document management systems, ERP platforms, databases, or manufacturing software.
Documentation Experience

Experience preparing, reviewing, updating, organizing, and maintaining technical or quality records. Familiarity with document control, version tracking, batch records, production records, or standard operating procedures is preferred.

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.

Get a complete career fit with Kelly.

You're looking to keep your career moving onward and upward, and we're here to help you do just that. Our staffing experts connect you with top companies for opportunities where you can learn, grow, and thrive. Jobs that fit your skills and experience, and most importantly, fit right on your path of where you want to go in your career.

Benefits
  • medical
  • dental
  • vision
  • telemedicine
  • term life
  • whole life
  • accident insurance
  • critical illness
  • a legal plan
  • short-term disability
  • a retirement savings plan
  • service bonus and holiday pay plans (earn up to eight paid holidays per benefit year)
  • a transit spending account
  • paid sick leave under the applicable state or local plan.

Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice.

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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