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Batch Record Specialist Jobs (NOW HIRING)

VIVEX BIOLOGICS INC

QA Batch Record Reviewer

Miami, FL · On-site

The QA Batch Record Reviewer performs functions necessary to assure that all relevant manufacturing ... Candidate should be certified as a Tissue Bank Specialist by the American Association of Tissue ...

Pyramid Laboratories Inc

QA Specialist

Costa Mesa, CA · On-site

$65K - $75K/yr

Batch Record Review * Independently review executed batch records and associated documents (testing ... specialist or supervisor. * Review deviations impacting batch quality and ensure proper ...

Pyramid Laboratories Inc

QA Specialist

Costa Mesa, CA · On-site

$65K - $75K/yr

Batch Record Review * Independently review executed batch records and associated documents (testing ... specialist or supervisor. * Review deviations impacting batch quality and ensure proper ...

INCOG

Operations Batch Review Specialist

Fishers, IN · On-site

Operations Batch Review Specialist The Operations Batch Review Specialist is responsible for ... Full batch documentation review of parenteral manufacturing Batch Records (Formulation, Filling ...

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Batch Record Specialist information

What is a batch record specialist?

Batch Record Specialists are professionals responsible for reviewing, managing, and ensuring the accuracy of batch production records in industries such as pharmaceuticals, biotechnology, and food manufacturing. They verify that all production and quality control processes are properly documented and comply with regulatory standards. Their work helps ensure the safety, consistency, and quality of products by making certain that each batch is thoroughly documented and compliant before it is released. Batch Record Specialists often collaborate with production, quality assurance, and regulatory teams to resolve discrepancies and maintain documentation integrity.

How does a batch record specialist typically collaborate with production and quality assurance teams?

A Batch Record Specialist works closely with both production and quality assurance (QA) teams to ensure that all manufacturing documentation is accurate, complete, and compliant with regulatory standards. They often review batch records for discrepancies, coordinate with production staff to resolve documentation issues, and communicate with QA to facilitate timely batch release. This collaboration is essential for maintaining product quality and meeting compliance requirements, often involving cross-departmental meetings and regular status updates.

What are the key skills and qualifications needed to thrive as a batch record specialist, and why are they important?

To thrive as a Batch Record Specialist, you need a strong understanding of Good Manufacturing Practices (GMP), document control, and quality assurance, typically supported by a degree in life sciences or a related field. Familiarity with electronic batch record (EBR) systems, document management software, and regulatory compliance tools is essential. Attention to detail, organizational skills, and effective communication are standout soft skills in this role. These capabilities ensure the accuracy and integrity of production records, compliance with regulations, and smooth manufacturing operations.

What is the difference between Batch Record Specialist vs Quality Assurance Technician?

AspectBatch Record SpecialistQuality Assurance Technician
Required CredentialsTypically a degree in life sciences or related field; GMP/GxP trainingLikewise, often a degree in science or engineering; GMP/GxP knowledge
Work EnvironmentManufacturing or pharmaceutical facilities, focusing on documentationQuality labs or manufacturing sites, focusing on testing and compliance
Employer & Industry UsagePharmaceutical, biotech, or medical device companiesSimilar industries, often overlapping in pharmaceutical manufacturing
Common Search & ComparisonYesYes

The Batch Record Specialist and Quality Assurance Technician roles share similar credentials and work environments within pharmaceutical and biotech industries. While the Batch Record Specialist primarily manages documentation and batch records, the Quality Assurance Technician focuses on testing and ensuring product quality. Both roles are essential for compliance and manufacturing efficiency, often overlapping in industry usage and employer expectations.

What cities are hiring for Batch Record Specialist jobs?

Cities with the most Batch Record Specialist job openings:

What states have the most Batch Record Specialist jobs?

States with the most job openings for Batch Record Specialist jobs include:

What are popular job titles related to Batch Record Specialist jobs?

For Batch Record Specialist jobs, the most frequently searched job titles are:

Infographic showing various Batch Record Specialist job openings in the United States as of June 2026, with employment types broken down into 83% Full Time, 14% Part Time, and 3% Contract. Highlights an 93% Physical, 2% Hybrid, and 5% Remote job distribution.

Batch Record Specialist

Bloomington, IN • On-site

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

Contractor

Re-posted 2 days ago

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.

  • Support deviation investigations, root cause analysis, and CAPA implementation activities.

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