Batch Record Review Specialist

job summary:
Launch your quality career with a Top-Tier Global Healthcare Leader in Round Lake, IL! This 100% on-site, 3-month contract position features high conversion-to-hire potential and abundant overtime opportunities. Working a steady 1st shift (Wednesday – Sunday, 8:00 AM – 5:00 PM), you will play a critical role in clearing batch release backlogs and upholding life-saving product quality standards.

location: Round Lake, IL
job type: 
salary: $260,000 – $300,000 per year
work hours: 9:00 AM – 5:00 PM
education: Master’s Degree

 

responsibilities:

• Perform comprehensive reviews of multi-page physical batch record folders for accuracy, omissions, and compliance with Good Documentation Practices (GDP).

• Investigate root causes of documentation discrepancies and partner directly with manufacturing personnel to resolve data gaps prior to final batch release.

• Organize, build, and maintain physical batch record folders utilizing numeric hard-copy filing systems.

• Track batch release workflows and document statuses using enterprise systems and Microsoft Office.

• Escalate critical compliance issues or recurring quality documentation deviations to QA leadership.

qualifications:

• 2+ years of documentation review or quality assurance experience in a regulated GMP environment (Pharma, Medical Device, Cosmetics, or Food).

• Strong working knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).

• Extreme attention to detail with proven ability to visualize manufacturing workflows through paper-based documentation.

• Proficiency in Microsoft Office Suite (Word, Excel) and comfort with hard-copy filing systems.

• Must not have known allergies to penicillin or cephalosporin antibiotics (manufactured on-site).

skills:  Good Documentation Practices (GDP), Good Manufacturing Practices (GMP), Batch Record Review, Batch Release, Document Control, Deviation Investigation, Physical Filing, Root Cause Analysis, Pharmaceutical Manufacturing, Quality Compliance

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact View email address on randstadusa.com.


Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).


This posting is open for thirty (30) days.