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Quality Assurance Biotech Jobs in Indiana (NOW HIRING)

Isotopia is a global biotech company manufacturing key ingredients for pharmaceutical cancer drugs ... We are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our ...

Isotopia is a global biotech company manufacturing key ingredients for pharmaceutical cancer drugs ... We are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our ...

Isotopia is a global biotech company manufacturing key ingredients for pharmaceutical cancer drugs ... We are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our ...

Functional Breadth * QA and QC experience in biotech pharmaceutical industry with environmental monitoring & cleanliness zones EEO Statement: The Novartis Group of Companies are Equal Opportunity ...

... A and QC experience in biotech pharmaceutical industry with environmental monitoring & cleanliness zones The pay range for this position at commencement of employment is expected to be between $88 ...

Manager, QA Compliance

Indianapolis, IN · On-site

$124K - $150K/yr

... biotech with the global expertise and resources of a leading innovator in oncology. Our mission is ... The Manager for QA Compliance provides management of activities for Site Quality Operations in ...

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Quality Assurance Biotech information

See Indiana salary details

$12

$27

$59

How much do quality assurance biotech jobs pay per hour?

As of Aug 16, 2026, the average hourly pay for quality assurance biotech in Indiana is $27.87, according to ZipRecruiter salary data. Most workers in this role earn between $17.84 and $32.69 per hour, depending on experience, location, and employer.

What is a quality assurance biotech?

A Quality Assurance (QA) Biotech job involves ensuring that biotechnology products meet regulatory and company standards for safety, efficacy, and quality. QA professionals develop and implement quality systems, conduct audits, review documentation, and ensure compliance with Good Manufacturing Practices (GMP) and other regulations. They collaborate with various departments, including manufacturing, R&D, and regulatory affairs, to maintain product integrity. Their role is critical in preventing defects, ensuring consistent processes, and maintaining compliance with industry standards.

What are the key skills and qualifications needed to thrive in quality assurance biotech?

To thrive as a Quality Assurance Biotech, you need a solid understanding of biotechnology processes, quality control methodologies, and regulatory standards such as GMP, often supported by a degree in biology, chemistry, or a related field. Familiarity with laboratory information management systems (LIMS), documentation software, and industry certifications like ASQ or GMP training is highly beneficial. Attention to detail, strong analytical thinking, and effective communication skills are valued soft skills in this role. These abilities ensure precise compliance with regulatory requirements, facilitate collaboration with cross-functional teams, and help maintain the integrity and safety of biotech products.

What are the most common challenges faced by quality assurance professionals in the biotech industry?

Quality Assurance professionals in biotechnology often encounter challenges related to staying up-to-date with evolving regulatory requirements and ensuring that all processes consistently meet strict quality standards. Additionally, managing thorough documentation and collaborating across various departments—such as research, manufacturing, and regulatory affairs—can be complex. Those in the role may also need to respond quickly to deviations or quality events, requiring both proactive problem-solving and excellent organizational skills. However, overcoming these challenges is highly rewarding, as it directly contributes to maintaining the safety and efficacy of biotech products.

What are the most commonly searched types of Quality Assurance Biotech jobs in Indiana?

The most popular types of Quality Assurance Biotech jobs in Indiana are:

What are popular job titles related to Quality Assurance Biotech jobs in Indiana?

For Quality Assurance Biotech jobs in Indiana, the most frequently searched job titles are:

What cities in Indiana are hiring for Quality Assurance Biotech jobs?

Cities in Indiana with the most Quality Assurance Biotech job openings:

Infographic showing various Quality Assurance Biotech job openings in Indiana as of July 2026, with employment types broken down into 1% As Needed, 78% Full Time, 15% Part Time, and 6% Contract. Highlights an 86% Physical, 1% Hybrid, and 13% Remote job distribution, with an average salary of $57,974 per year, or $27.9 per hour.

Quality Assurance Specialist

Stark Pharma Solutions Inc

Indianapolis, IN • On-site

Contractor

Re-posted 21 days ago


Job description

Job Title: Quality Assurance Specialist

Location: Indianapolis, IN
Duration: Long Term

Job Summary

We are seeking a detail-oriented Quality Assurance Specialist to support quality agreement management activities within a GMP-regulated pharmaceutical/biotech environment. The ideal candidate will be responsible for drafting, reviewing, negotiating, and maintaining quality agreements to ensure compliance with GxP regulations and internal quality standards.

The Quality Assurance Specialist will collaborate with internal cross-functional teams and external partners to support supplier qualification, regulatory compliance, and manufacturing readiness activities.

Key Responsibilities

  • Draft, review, revise, and maintain quality agreements in alignment with internal SOPs, GxP regulations, and company quality standards
  • Manage the full lifecycle of quality agreements from initiation through negotiation, execution, renewal, and closure
  • Partner with Quality Assurance, Procurement, Legal, Regulatory, and Manufacturing teams to resolve open items and obtain required approvals
  • Coordinate with external vendors, suppliers, and business partners to negotiate agreement terms and address redline comments
  • Maintain accurate tracking of agreement status, milestones, approvals, and version history within document management systems
  • Identify, communicate, and escalate risks or delays that may impact supplier qualification, product quality, regulatory compliance, or manufacturing operations
  • Support deviation investigations, CAPA activities, and change control processes related to quality systems documentation
  • Ensure compliance with FDA, cGMP, GDP, and internal quality management system requirements
  • Assist with internal audits, supplier audits, and regulatory inspections by providing quality documentation and support
  • Participate in continuous improvement initiatives related to quality agreement processes, templates, and document workflows

Experience

  • 3–5+ years of experience in a regulated pharmaceutical, biotechnology, medical device, or life sciences environment
  • Direct experience managing quality agreements, supplier quality documentation, or GxP-controlled records
  • Strong understanding of FDA regulations, cGMP, GDP, and quality systems requirements
  • Experience with document management systems, change control, CAPA, and deviation management processes
  • Strong technical writing, communication, negotiation, and organizational skills
  • Ability to manage multiple projects and deadlines within a fast-paced regulated environment