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Weekend Batch Record Reviewer 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.

Actalent

QA Associate

Clinton, IN · On-site

Experience with batch record review and batch record maintenance. * Knowledge of cGMP principles and quality assurance practices. * Ability to perform QA tests, QA checks, and QA documentation tasks ...

INCOG

QA Associate - IDAP, 3rd Shift

Fishers, IN · On-site

Support other QA personnel with batch record reviews, material release, etc. * Prioritize and ... This position will support primarily third shift (11:00pm-7:30am) with occasional weekend support ...

INCOG

QA Associate

Fishers, IN · On-site

Support other QA personnel with batch record reviews, material release, etc. * Prioritize and ... This position will support primarily first shift (7 am to 4 pm) with occasional weekend support ...

INCOG

QA Associate, 2nd Shift

Fishers, IN · On-site

Support other QA personnel with batch record reviews, material release, etc. * Prioritize and ... This position will support primarily second shift (3 pm to 11:30 pm) with occasional weekend ...

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Infographic showing various Weekend Batch Record Reviewer job openings in Indiana as of August 2026, with employment types broken down into 1% As Needed, 80% Full Time, 15% Part Time, and 4% Contract. Highlights an 93% Physical, 2% Hybrid, and 5% Remote job distribution.

Batch Record Specialist

Stark Pharma Solutions Inc

Bloomington, IN • On-site

Contractor

Re-posted 11 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