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Quality Control Stability Jobs in Indiana (NOW HIRING)

QC Planner

Fishers, IN · On-site

$22.50 - $30.25/hr

... and stability samples. • Ensures schedule stability by minimizing short term changes. • ... Quality Control in a regulated environment. • Project management and awareness of scheduling ...

QC Planner

Fishers, IN

$21.50 - $29/hr

... and stability samples. • Ensures schedule stability by minimizing short term changes. • ... Quality Control in a regulated environment. • Project management and awareness of scheduling ...

QC Planner

Fishers, IN

$21.50 - $29/hr

... and stability samples. • Ensures schedule stability by minimizing short term changes. • ... Quality Control in a regulated environment. • Project management and awareness of scheduling ...

QC Planner

Fishers, IN

$22.50 - $30.25/hr

Quality Control Planner Summary The Quality Control Planner will play a crucial role at INCOG ... Ensures schedule stability by minimizing short term changes. Maintains equipment calibration and ...

QC Analyst

Lebanon, IN · On-site

$23 - $31/hr

Support QC data management, sample/result tracking, and development of Electronic Lab Notebook (ELN ... Experience with COAs, stability reports, SOPs * Good technical writing and communication skills ...

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 ...

Establish and maintain the stability program * Oversee LIMS development, implementation, operation ... QC functional area KNOWLEDGE, SKILLS, AND EXPERIENCE EDUCATION / CERTIFICATIONS / LICENSES ...

Establish and maintain the stability program * Oversee LIMS development, implementation, operation ... QC functional area KNOWLEDGE, SKILLS, AND EXPERIENCE EDUCATION / CERTIFICATIONS / LICENSES ...

Establish and maintain the stability program * Oversee LIMS development, implementation, operation ... QC functional area KNOWLEDGE, SKILLS, AND EXPERIENCE EDUCATION / CERTIFICATIONS / LICENSES ...

... stability, developmental and raw material samples within the established turnaround times in the ... Actively participates and/or leads quality control investigations related to OOS/Event/Deviation ...

... stability, developmental and raw material samples within the established turnaround times in the ... Actively participates and/or leads quality control investigations related to OOS/Event/Deviation ...

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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 cities in Indiana are hiring for Quality Control Stability jobs? Cities in Indiana with the most Quality Control Stability job openings:
QC Planner

$22.50 - $30.25/hr

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 19 days ago


Job description

Description
Quality Control Planner Summary
The Quality Control Planner will play a crucial role at INCOG within the QC laboratory, ensuring the efficient planning and coordination of various Quality Control activities.
Essential Job Functions:
• Performs analysis to determine optimal testing schedule for QC laboratories with a combination of key inputs, including Customer requirements from the Project Management personnel, production sequencing personnel and equipment availability.
• Coordinates sample management for QC laboratories.
• Collaborate with cross-functional teams to develop and implement QC sampling and testing strategies.
• Develop and maintain reference standard, reagent and consumable inventory levels to prevent stockouts or overstock situation for the QC laboratories. Implement inventory control measures and optimize stock rotation.
• Interprets and communicates special requirements to appropriate personnel.
• Updates new plans and changes in the inventory management system.
• Develop and maintain sampling plans for incoming, production and stability samples.
• Ensures schedule stability by minimizing short term changes.
• Maintains equipment calibration and maintenance schedules.
• Responsible for updating existing reports and developing new ones.
• Responsible for tracking departmental performance metrics, as required.
• Work closely with all internal and external suppliers and vendors.
• Maintain work area to 6S standards as posted in work area.
• Maintain SOPs (Standard Operating Procedure) for all duties and tasks.
Special Job Requirements:
• Bachelor's degree in science.
• Minimum of 3 years of biopharma industry experience, of which at least 2 years have been in a role of hands-on experience with Quality Control in a regulated environment.
• Project management and awareness of scheduling tools.
• First-hand experience participating in and/or hosting audits/inspections related to Quality Control.
• Exceptional computer skills evidenced by hands-on work with automated data management and/or data analysis systems (LIMS, SharePoint, PowerBI etc.).
INCOG's Benefits:
• Paid time off, based on tenure
• 9 observed holidays + 2 floating holiday
• 401(k) plan with company match up to 3.5% of salary, vested immediately
• Choice of health & wellness plans
• FSA and HSA programs
• Dental & vision care
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.