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Batch Record Review Jobs in Indiana (NOW HIRING)

INCOG

QA Batch Review Specialist

Fishers, IN · On-site

Full lifecycle review and disposition of parenteral manufacturing Batch Records (Formulation, Filling, Inspection, & Packaging) for Media Fills and Drug Product. Provide Client access and support in ...

INCOG

Senior QA Batch Disposition Specialist

Fishers, IN · On-site

$77K - $106K/yr

Lead full lifecycle review and disposition of parenteral manufacturing batch records (Formulation, Filling, Inspection, and Packaging) for Media Fills and Drug Product across all production stages.

VIVOS HOLDINGS

QA TECHNICIAN 1

Mooresville, IN · On-site

$20.24/hr

This position reviews batch records including digital data in the Laboratory Information Management System (LIMS) and Shop Floor Control system, collaborates with the Quality Assurance and ...

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Batch Record Review information

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$12

$19

$32

How much do batch record review jobs pay per hour?

As of Aug 30, 2026, the average hourly pay for batch record review in Indiana is $19.35, according to ZipRecruiter salary data. Most workers in this role earn between $16.49 and $20.14 per hour, depending on experience, location, and employer.

What is a batch record reviewer?

A Batch Record Reviewer is a quality assurance professional responsible for reviewing and verifying production batch records in pharmaceutical or manufacturing environments. Their main role is to ensure that all documentation related to the production of each batch complies with regulatory standards and company procedures. This includes checking for accuracy, completeness, and compliance with Good Manufacturing Practices (GMP). By doing so, they help maintain product quality and safety before products are released to the market.

What skills and qualifications are needed to be a batch record reviewer?

To thrive as a Batch Record Reviewer, you need strong attention to detail, knowledge of Good Manufacturing Practices (GMP), and experience in pharmaceutical or biotechnology documentation, often supported by a degree in life sciences or related fields. Familiarity with electronic document management systems (EDMS), quality management software, and regulatory compliance tools is typically required. Excellent analytical skills, organization, and effective communication are standout soft skills for this role. These abilities ensure the accuracy, compliance, and completeness of batch records, which are critical for product quality and regulatory approval.

What are common challenges faced in a batch record review role, and how can they be addressed?

One common challenge in a Batch Record Review role is ensuring the completeness and accuracy of documentation while working under tight deadlines, as production schedules often depend on timely batch release. Attention to detail is critical, since even minor discrepancies can lead to delays or compliance issues. Effective communication and collaboration with production, quality assurance, and laboratory teams are key to resolving discrepancies quickly. Proactively staying updated on current Good Manufacturing Practices (cGMP) and internal protocols can also help minimize errors and streamline the review process.

What is the difference between Batch Record Review vs Quality Control Analyst?

AspectBatch Record ReviewQuality Control Analyst
Primary RoleReview and approve manufacturing batch records for compliance and accuracyPerform testing and analysis of raw materials, in-process, and finished products
CertificationsOften requires GMP, cGMP, or industry-specific certificationsRequires laboratory certifications, such as ASQ or equivalent
Work EnvironmentManufacturing or production facilities, quality assurance departmentsLaboratories, quality control labs, manufacturing sites
Industry UsagePharmaceutical, biotech, and manufacturing sectorsPharmaceutical, biotech, and food industries

While both roles focus on quality, Batch Record Review primarily involves reviewing manufacturing documentation for compliance, whereas Quality Control Analysts conduct testing and analysis to ensure product quality. Both are essential in regulated industries and often collaborate to maintain product standards.

What job categories do people searching Batch Record Review jobs in Indiana look for?

The top searched job categories for Batch Record Review jobs in Indiana are:

Batch Record Review jobs near you
Infographic showing various Batch Record Review job openings in Indiana as of August 2026, with employment types broken down into 33% Full Time, and 67% Contract. Highlights an 100% In-person job distribution, with an average salary of $40,255 per year, or $19.4 per hour.

Batch Record Specialist

Bloomington, IN • On-site

Stark Pharma Solutions Inc
See more jobs at Stark Pharma Solutions Incexternal

Contractor

Re-posted 19 days ago

Job description

Hi,

My name is Karthik Mutyala, from Stark Pharma Solutions Inc, we are hiring talents for our client. I am working on Batch Record Specialist position right now. Please send me your updated resume if you have relevant experience and interested in this position. The detailed job description is as follows.

Role: Batch Record Specialist

Location: Indiana (Onsite)
Duration: 6-Month Contract
 

Position Overview

We are seeking an experienced Operations Batch Review Specialist to support manufacturing operations within a GMP-regulated pharmaceutical environment. This role will be responsible for reviewing executed batch records and manufacturing documentation to ensure compliance with cGMP requirements, regulatory standards, and internal procedures.

The ideal candidate will possess strong batch record review experience, a solid understanding of parenteral manufacturing processes, and the ability to collaborate with Operations, Quality, and Manufacturing teams to drive documentation accuracy, deviation resolution, and continuous improvement initiatives.

Key Responsibilities

  • Review completed batch records and manufacturing documentation for accuracy, completeness, and compliance with cGMP requirements.
  • Verify manufacturing activities were performed according to approved procedures, specifications, and regulatory standards.
  • Identify documentation errors, discrepancies, and potential deviations, ensuring appropriate corrections are completed.
  • Partner with Manufacturing Operations to provide coaching and guidance on good documentation practices.
  • Support deviation investigations, root cause analysis, and CAPA implementation activities.
  • Collaborate with Quality Systems, Production, and Technical Operations teams to resolve documentation and compliance issues.
  • Ensure batch review activities are completed within production timelines while maintaining quality standards.
  • Assist with continuous improvement initiatives related to documentation practices and operational compliance.
  • Build strong working relationships with process owners, supervisors, and subject matter experts to drive quality-focused outcomes.

Required Qualifications

  • Experience performing full batch record review in GMP-regulated pharmaceutical manufacturing environments.
  • Strong knowledge of parenteral manufacturing operations, including:
    • Formulation
    • Filling
    • Inspection
    • Packaging
  • Experience identifying and documenting deviations, investigations, and corrective actions.
  • Ability to coach operators and manufacturing personnel on documentation requirements and compliance expectations.
  • Strong understanding of:
    • cGMP Regulations
    • Process Control
    • Quality Systems
    • Sampling Plans
    • Statistical Techniques
    • Process Capability
  • Excellent written and verbal communication skills.
  • Strong organizational skills with the ability to manage multiple priorities and deadlines.

I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with the best number and time to reach you.  

Please follow Stark Pharma Solutions on LinkedIn for the latest job updates: https://www.linkedin.com/company/99455976/

Thank you,

Karthik Mutyala

Recruiting Manager

Stark Pharma Solutions Inc

Ph: +1 848 215 3128

Email: karthik@starkpharma.com

15 Corporate Place S, Suite 350,

Piscataway, New Jersey 08854

www.starkpharma.com