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Batch Record Review Jobs in Indiana (NOW HIRING)

INCOG BioPharma Services

QA Associate

Fishers, IN

Support other QA personnel with batch record reviews, material release, etc. * Prioritize and coordinate his/her time in balancing production timelines with product quality assurances. * Exercise ...

INCOG

QA Associate, 2nd Shift

Fishers, IN · On-site

Support other QA personnel with batch record reviews, material release, etc. * Prioritize and coordinate his/her time in balancing production timelines with product quality assurances. * Exercise ...

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How much do batch record review jobs pay per hour?

As of Aug 9, 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 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 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 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 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 popular job titles related to Batch Record Review jobs in Indiana? For Batch Record Review jobs in Indiana, the most frequently searched job titles are:
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 71% Full Time, and 29% Contract. Highlights an 100% In-person job distribution, with an average salary of $40,255 per year, or $19.4 per hour.

QA Associate, 2nd Shift

INCOG BioPharma Services

Fishers, IN • On-site

Full-time

Re-posted yesterday

Job description

Description
Working closely with the QA Supervisor, the QA Associate will be instrumental in ensuring site compliance with Regulations, ISO Standards, organizations SOPs as well as support in championing and developing organization's Quality Mindset, as well as a culture of efficiency, attention to detail, and on time delivery. The QA Associate will need to provide support with identifying operational and quality gaps.
The Quality Assurance Associate will exemplify excellent interpersonal skills and be capable of developing productive, customer-centric working relationships with colleagues, internal customers, and partners. The QA Associate will demonstrate excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences. The QA Associate will thrive in a team environment but will also work autonomously utilizing strong self-management and organizational skills. The QA Associate will value process owners and subject matter experts and will possess a demonstrated ability in influencing positive outcomes without direct reporting authority.
Essential Job Functions:
  • Maintain a Quality Assurance presence and provide process confirmation on the manufacturing floor.
  • Review and approve documentation for Quality approval, including but not limited to on-floor batch record review, logbooks, work orders, procedures, etc.
  • Collaborate with Manufacturing/Operations team and lead or provide support with investigations to resolve equipment and process related deviations.
  • Support other QA personnel with batch record reviews, material release, etc.
  • Prioritize and coordinate his/her time in balancing production timelines with product quality assurances.
  • Exercise rapid decision-making in the preliminary evaluation of the scope and impact of deviating events, requirements for product segregation, and the implementation of initial corrective actions or escalate the issue to Manager for resolution.
  • Provide support as needed in a cross-functional capacity on deviation investigative processes using root cause analysis tools, report writing, and mitigation development using risk analysis tools.
  • Exemplify and take proactive approaches in terms of safety expectations, practice positive intervention, and enforce best practices that align to SOPs, compliance requirements, quality guidelines, and site goals.
  • Utilize various paper and automated systems (Veeva, SCADA, BMS, CMMS, LIMS, lab instrument software, etc.) to ensure data integrity for site policies, procedures, and batch records.
  • Use technical skills and applied statistics to analyze and track deviations and to identify sources of variability and error site processes.
  • Ability to manage multiple projects in a fast-paced environment.

Special Job Requirements:
  • This position will support primarily second shift (3 pm to 11:30 pm) with occasional weekend support, dependent on operations' needs.
  • Bachelor's Degree required or equivalent; degree preferred to be in Science (Chemistry, Biology, Biochemistry, Microbiology etc.).
  • Must demonstrate visual acuity of 20/20 or better, with or without corrective lenses.
  • Minimum of 2 years with experience working as Quality in a GMP Manufacturing environment, and/or as an Operator within a Pharmaceutical Manufacturing environment.
  • Moderate knowledge of regulations and quality systems such as deviations, Non-Conformance, CAPA, etc..
  • Understanding of Good Documentation Practices (GDPs) and its criticality.
  • Excellent written and verbal communication skills.
  • General computer skills evidenced by hands-on work with computerized Operations equipment (SCADA); and reporting and data analysis software (Word, Excel, Visio, JMP, Minitab, etc.).

Additional Preferences:
  • Hands-on experience with aseptic manufacturing, inspecting finished products, and Acceptable Quality Limits (AQLs).
  • Experience with Continuous improvement, Six Sigma, and/or Lean principles.

Additional info about INCOG BioPharma Services:
At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.
If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.
INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
Qualified applicants must be authorized to work in the United States on a full-time basis. INCOG will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
By submitting your resume and details, you are declaring that the information is correct and accurate.

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