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Quality Control Stability Jobs in Indiana (NOW HIRING)

INCOG

QC Microbiology Technician, 2nd Shift

Fishers, IN

$23.75 - $31.25/hr

The QC Microbiology Technician will perform routine sampling for items undergoing QC testing ... stability samples. Performs routine environmental monitoring of facility. Performs common ...

INCOG

QC Scientist (Weekend Shift)

Fishers, IN

Weekend QC Scientist Summary The Weekend QC Scientist supports GMP manufacturing and laboratory ... stability, environmental, or validation-related samples, as assigned.process samples, finished ...

INCOG

QC Technician (Weekend Shift)

Fishers, IN

$18.50 - $23.50/hr

Weekend QC Technician Summary The Weekend QC Technician supports GMP manufacturing and laboratory ... stability, environmental, or validation-related samples, as assigned. process samples, finished ...

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Quality Control Stability information

What are the key skills and qualifications needed to thrive as a Quality Control Stability specialist, and why are they important?

To thrive as a Quality Control Stability specialist, you need a solid background in chemistry or related sciences, experience with stability testing, and typically a bachelor’s degree in a scientific field. Familiarity with laboratory instruments (such as HPLC, GC), stability management systems, and knowledge of regulatory guidelines like ICH are essential. Attention to detail, problem-solving, and strong organizational skills help ensure accurate data analysis and effective reporting. These abilities are crucial for maintaining compliance, product safety, and reliability in pharmaceutical or biotech environments.

What are some common challenges faced in a Quality Control Stability role, and how can they be addressed?

Professionals in Quality Control Stability often encounter challenges such as managing tight timelines for stability testing, interpreting ambiguous results, and ensuring compliance with evolving regulatory requirements. Effective communication with cross-functional teams—such as R&D, production, and regulatory affairs—is essential to address discrepancies and maintain data integrity. Staying organized, maintaining thorough documentation, and keeping up to date with industry guidelines help mitigate these challenges and ensure smooth workflow.

What is a Quality Control Stability role?

A Quality Control Stability role involves monitoring and evaluating the stability of pharmaceutical products, ensuring they maintain their quality, safety, and efficacy throughout their shelf life. Professionals in this position design and execute stability studies, analyze the results, and document findings according to regulatory requirements. They play a crucial part in ensuring compliance with industry standards and supporting product development and release. This role typically requires expertise in analytical testing, regulatory guidelines, and laboratory practices.

What is the difference between Quality Control Stability vs Quality Control Inspector?

AspectQuality Control StabilityQuality Control Inspector
CertificationsOften requires certifications like Six Sigma, ISO auditor, or quality management certificationsTypically requires quality inspection certifications or training
Work EnvironmentFocuses on maintaining process stability in manufacturing or production settingsPerforms inspections on products or materials on the production line
Employer & Industry UsageUsed in manufacturing, aerospace, automotive, and industries emphasizing process consistencyCommon in manufacturing, food production, and assembly lines

Quality Control Stability involves ensuring that manufacturing processes remain consistent over time, emphasizing process control and reduction of variability. In contrast, a Quality Control Inspector primarily conducts inspections to verify product quality at various stages. Both roles are essential in quality management but focus on different aspects of quality assurance.

What are popular job titles related to Quality Control Stability jobs in Indiana? For Quality Control Stability jobs in Indiana, the most frequently searched job titles are:
What job categories do people searching Quality Control Stability jobs in Indiana look for? The top searched job categories for Quality Control Stability jobs in Indiana are:
What cities in Indiana are hiring for Quality Control Stability jobs? Cities in Indiana with the most Quality Control Stability job openings:
Quality Control Stability jobs near you

QC Compliance Specialist, 3rd Shift

INCOG

Fishers, IN

Full-time

Posted 6 days ago

Job description

The Quality Control Compliance Specialist plays a vital role on the QC team with analytical and microbiological testing experience. This role will support laboratory processing of finished product, incoming materials, and stability sample release.


Essential Job Functions:

  • This position will support primarilythirdshift(11 pm to 7:30 am) with occasional overtime support, dependent on operations' needs.

  • Perform in-depth technical data review of all analytical and microbiological testing performed on finished products - in-process samples, stability samples, raw material samples, and environmental samples, ensuring compliance with GMPs. Review includes both technical review of method performance as well as confirming data integrity elements, e.g. good documentation practices, audit trail reviews, etc.

  • Generate QC data summary documents such as certificates of analysis and stability study summary reports.

  • Provide SME support for electronic QC database systems and laboratory data integrity compliance (OpenLab etc) to support the QC laboratories.

  • Revise and improve technical writing documents such as analytical methods, specifications, protocols, SOPs, templates, etc.

  • Assist laboratory management as a mentor in the development of all levels of analysts in the laboratory. This mentorship includes technical guidance regarding GMP fundamentals, chromatographic/spectrographic systems, and general analytical testing.

  • Provide laboratory information and documentation requests to site management and customers required for regulatory filings and product import/export needs, when required.

  • Provide support for instrument troubleshooting, instrument repair, and instrument calibrations for the QC laboratories.

  • As a part of the employee's job requirements, the employee may be required to handle waste including hazardous waste. The employee must attend mandatory annual hazardous waste training meeting(s) and show competency in that training by passing test(s) administered by the company or consultant providing such training.


Minimum Requirements:

  • Bachelor's degree in Chemistry, Biology, or related sciences

  • Analytical and/or microbiology experience

  • 5+ years of experience in lab or quality roles


Additional Preferences:

  • Advanced degree

  • Experience in QC testing

  • Experience with data review

  • Experience in regulated industries


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.


By submitting your resume and details, you are declaring that the information is correct and accurate.

Employment Type: Full-Time

About INCOG

Sourced by ZipRecruiter

Industry

Public administration

Company size

51 - 200 Employees

Headquarters location

Tulsa, OK, US

Year founded

1967

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