QA Records Specialist – GMP Documentation Expert

Kelly; Melrose Park (IL); On-site; USD 33,000 - 39,000; Full time

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

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.