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Quality Assurance Cdmo Jobs in Indiana (NOW HIRING)

SpectronRx

QA Specialist

Indianapolis, IN · On-site

$27 - $30/hr

Quality Assurance Specialist COMPANY OVERVIEW SpectronRx is a growing Contract Development and Manufacturing Organization (CDMO) based in Indianapolis, Indiana, and production locations in South Bend ...

INCOG

Senior QA Specialist, Supplier Quality

Fishers, IN

$77K - $106K/yr

Join our dynamic Quality Assurance team as a QA Senior Specialist - Supplier Quality, where you'll ... At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture ...

INCOG

QA Client Representative

Fishers, IN · On-site

$19.25 - $23.50/hr

The Quality Assurance Client Representative will provide support with identifying and closing ... At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture ...

INCOG BioPharma Services

QA Client Representative

Fishers, IN · On-site

$19.25 - $23.50/hr

The Quality Assurance Client Representative will provide support with identifying and closing ... At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture ...

INCOG

QA Batch Review Specialist

Fishers, IN · On-site

The QA Specialist - Batch Review will at all times provide support with identifying and closing ... At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture ...

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Quality Assurance Cdmo information

What is a quality assurance CDMO?

A Quality Assurance CDMO refers to the quality assurance function within a Contract Development and Manufacturing Organization (CDMO). CDMOs are companies that provide services to pharmaceutical and biotechnology firms to develop and manufacture drugs. The Quality Assurance (QA) team ensures that all products and processes meet regulatory standards and client requirements. Their role includes overseeing compliance, conducting audits, reviewing documentation, and ensuring that manufacturing practices align with Good Manufacturing Practice (GMP) guidelines. This helps ensure the safety, efficacy, and quality of the pharmaceutical products produced.

What are the key skills and qualifications needed to thrive as a quality assurance CDMO?

To thrive as a Quality Assurance CDMO (Contract Development and Manufacturing Organization), you need a solid background in quality management systems, regulatory compliance (such as cGMP and ISO), and a degree in life sciences or a related field. Familiarity with tools like LIMS, CAPA systems, and experience with FDA or EMA audit processes is typically required. Strong attention to detail, problem-solving abilities, and effective communication are essential soft skills for this role. These competencies ensure that products meet stringent quality standards and regulatory requirements, safeguarding patient safety and organizational reputation.

What are some common challenges faced by quality assurance professionals in a CDMO environment, and how can they be addressed?

Quality Assurance professionals in a Contract Development and Manufacturing Organization (CDMO) often encounter challenges such as adapting to diverse client requirements, ensuring compliance with varying regulatory standards, and managing multiple projects simultaneously. To address these challenges, professionals must be adept at communicating with cross-functional teams, stay updated on evolving regulations, and develop strong project management skills. Emphasizing collaboration, continuous training, and proactive risk management can help QA professionals excel in this dynamic and fast-paced environment.

What is the difference between Quality Assurance Cdmo vs Quality Control Specialist?

AspectQuality Assurance CdmoQuality Control Specialist
CertificationsGMP, ISO, QA certificationsGMP, ISO, QC certifications
Work EnvironmentRegulatory compliance, process validation, documentationProduct testing, inspection, sample analysis
Industry UsagePharmaceutical, biotech, CDMO companiesManufacturing, production facilities

Quality Assurance Cdmo professionals focus on establishing and maintaining quality systems, ensuring compliance, and validating processes within CDMO settings. In contrast, Quality Control Specialists primarily perform product testing and inspection to verify quality. Both roles are essential in the pharmaceutical industry but differ in scope and responsibilities.

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

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

What job categories do people searching Quality Assurance Cdmo jobs in Indiana look for?

The top searched job categories for Quality Assurance Cdmo jobs in Indiana are:

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

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

Quality Assurance Cdmo jobs near you
Infographic showing various Quality Assurance Cdmo job openings in Indiana as of August 2026, with employment types broken down into 84% Full Time, and 16% Contract. Highlights an 100% In-person job distribution.

QA Specialist

SpectronRx

Indianapolis, IN • On-site

$27 - $30/hr

Full-time

This job post has expired today. Applications are no longer accepted.

Job description

Quality Assurance Specialist
COMPANY OVERVIEW
SpectronRx is a growing Contract Development and Manufacturing Organization (CDMO) based in Indianapolis, Indiana, and production locations in South Bend, IN; Bunker Hill, IN; and Danbury, CT with plans for additional future production facilities. We are seeking an experienced QA Specialist to join our growing company. To be successful as a Quality Assurance Specialist, you should be incredibly thorough and able to help our company maintain the highest quality standards.
ESSENTIAL FUNCTIONS
  • Preparing and implementing quality assurance policies and procedures.
  • Performing routine inspections and quality tests.
  • Identifying and resolving workflow and production issues.
  • Ensuring that standards and safety regulations are observed.
  • Addressing and discussing issues and proposed solutions with superiors.
  • Documenting quality assurance activities and creating audit reports.
  • Maintaining site documentation.
  • Preparing documentation and materials required for batch production and QC.
  • Material acceptance and creation of material specification sheets.
  • Oversee the examination and evaluation of each lot of incoming material before use to ensure that the material meets its established specifications.
  • Maintain employee training binders.
  • Assist Site and Corporate QA in internal audits and making recommendations for improvement.
  • Creating training materials and operating manuals as requested by Site and Corporate QA.
  • Liaise with external inspectors, CMO representatives, particularly on QA-related topics and take minutes of meetings, if requested.
  • Assist in the oversight of the metrology program at the site. (equipment/personnel qualifications/validations, etc.)
  • Assist as required with all other site QA activities not otherwise listed above.
  • Attend quality related meetings and conference calls. Interface with Corporate QA on quality related issues. Provide any status updates as required by Corporate QA.
  • Performs other related duties as assigned.
  • Physical Ability – Must be able to lift up to 50 pounds at a time and stand for prolonged periods.
  • Attention to Detail – Ability to accurately count, verify, and record data.
  • Active Listening – Giving full attention to instructions and communications, asking questions as appropriate.
  • Speaking – Talking to others to convey information effectively.
  • Time Management – Managing own time to prioritize tasks and meet deadlines.
  • Coordination – Adjusting actions in relation to others’ actions in a team environment.
  • Oral Comprehension – The ability to listen to and understand information and ideas presented through spoken words and sentences.
  • Written Comprehension – The ability to read and understand information and ideas presented in writing.
  • Basic Math Skills – Ability to count accurately and perform basic arithmetic for reconciliation.
  • Organizational Skills – Ability to maintain orderly areas and accurate records.
TRAVEL
  • Regular travel is minimal.
REQUIRED EDUCATION AND EXPERIENCE
  • High school diploma or equivalent education required.
  • Proficiency in Microsoft office (Microsoft Word, Excel, and Outlook, Microsoft PowerPoint) and Adobe Acrobat required.
  • Excellent customer service
  • Excellent communication and organizational skills.
  • Ability to train and be trained.
  • Excellent data collection and analysis skills.
  • Strong attention to detail.
  • Previous experience in quality assurance or similar field.
  • Working knowledge of tools, methods, and concepts of quality assurance.
  • Solid knowledge of relevant regulatory standards.
  • Thorough understanding of project management.
  • Excellent organizational skills and attention to detail.
PREFERRED EDUCATION AND EXPERIENCE
  • Familiarity with a manufacturing or production environment.
  • Bachelor’s degree preferred.
  • Certificate in quality assurance is a plus.
ADDITIONAL REQUIREMENTS
  • Valid Indiana driver’s license.
  • Pass a Background Check.
  • Prolonged periods of standing, walking, bending, and lifting.

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