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Quality Control Stability Jobs in Indiana (NOW HIRING)

INCOG BioPharma Services

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 ...

INCOG

QC Planner

Fishers, IN · On-site

$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 ...

INCOG BioPharma Services

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 ...

INCOG BioPharma Services

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 ...

Intellectt INC

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 ...

INCOG

QC Sample Management Technician

Fishers, IN · On-site

$17.50 - $22.50/hr

Receive, inspect, and log QC samples from manufacturing, stability, utilities, and external sources in accordance with approved SOPs. * Routinely monitor, and facilitate, transfer of samples from the ...

INCOG

QC Compliance Specialist

Fishers, IN · On-site

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 ...

Aquestive Therapeutics

Senior QC Chemist

Portage, IN · On-site

... 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 ...

Aquestive Therapeutics

Senior QC Chemist

Portage, IN · On-site

... 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 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.

Is a QC inspector job stressful?

A Quality Control Stability inspector's job can be stressful due to strict deadlines, attention to detail, and the need for accuracy in inspections. The work environment often involves repetitive tasks and the responsibility of ensuring product quality, which can contribute to job-related stress.

What is the maximum salary of QC?

The maximum salary for a Quality Control (QC) professional varies depending on experience, location, and industry, but senior QC managers can earn over $100,000 annually. Factors such as certifications, specialized skills, and working in high-demand sectors can influence earning potential.

What jobs pay $10,000 a month without a degree?

In quality control stability roles, high-paying positions typically require specialized skills or certifications rather than a traditional degree. Jobs such as freelance consulting, quality assurance specialists, or technical auditors can reach or exceed $10,000 monthly with experience and expertise, often involving industry-specific knowledge and certifications. Most roles in this field emphasize practical skills, attention to detail, and industry experience over formal education.

What is a QC stability specialist job description?

A QC stability specialist is responsible for testing and analyzing the stability of pharmaceutical or cosmetic products over time to ensure they meet quality standards. They perform laboratory tests, review data, and maintain documentation to support product shelf life and compliance requirements, often using specialized testing equipment and following regulatory guidelines.

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 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 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 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
Director, Quality Control

Director, Quality Control

Aquestive Therapeutics Inc.

Portage, IN

Other

Posted 10 days ago

Job description

Job Summary: The Director, Quality Control serves as the commercial CMC analytical owner, accountable for ensuring analytical methods, stability programs, and laboratory operations collectively enable compliant product supply and lifecycle management. This position will be expected to work in a highly collaborative, cross functional team environment, provide expert knowledge to risk identification/mitigation, strategy and execution and is expected to make scientific and business critical decisions. Responsibilities: Analytical Strategy Direct QC support for CMC development, regulatory submissions, and product lifecycle management across all products Ensure alignment of QC activities with regulatory submissions (IND, NDA, MAA) and post-approval commitments Establish robust transfer strategies, protocols, acceptance criteria, and success metrics Commercial Analytical CMC Ownership Accountable for CMC readiness and sustainment post-approval Ensure CMC deliverables are complete, scientifically sound and inspection ready.

Own post-approval analytical CMC lifecycle, including Annual Product Reviews / trending, change controls impacting filings, lifecycle improvements and optimization Stability Program Oversight Own stability as a CMC deliverable linked to shelf life, regulatory and partner commitments and supply Provide scientific assessment of stability trends, OOT results, and potential impact to product quality Partner with Quality, AR&D and Regulatory to support IND/NDA/MAA submissions, post-approval commitments and annual updates Laboratory Operations Direct day-to-day QC lab operations (release, stability, in-process, raw materials) Ensure timely and reliable testing to support manufacturing and release schedules Maintain laboratory compliance with cGMP, data integrity, and ALCOA+ principles Oversee scheduling, capacity planning, and resource management External Laboratories & CDMO Oversight Provide oversight of contract laboratories and CDMOs performing analytical testing Review and approve analytical data, deviations, and investigations from external partners Support Quality Agreements and clearly defined analytical responsibilities Investigations & Problem Solving Lead complex OOS, OOT, and deviation investigations related to analytical results and product performance Drive root cause analysis and scientifically sound CAPAs Partner cross-functionally to resolve issues Compliance & Inspection Readiness Ensure QC systems meet global regulatory expectations (FDA, EMA, ICH) Lead inspection readiness activities and serve as QC lead during inspections Ensure data integrity, documentation practices, and audit responses meet expectations People Leadership Lead, develop, and scale QC laboratory teams (scientists, analysts, managers) Build strong technical and compliance culture with clear accountability Drive capability building in analytical science, problem-solving, and inspection readiness Participate in all third party and customer audits and inspections, and corrective action response. QUALIFICATIONS PhD, MS, or BS in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or related field 10–15+ years in pharmaceutical/biotech Quality Control or Analytical Sciences Significant experience in: CMC development and commercialization, Analytical method development, validation, and transfer, Managing QC labs in a cGMP environment Strong understanding of regulatory expectations (FDA, EMA, ICH) Experience overseeing CDMOs and contract laboratories Proven leadership in inspections and complex investigations Strong business acumen surrounding pharmaceutical manufacturing. Some travel is required The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position.

This is not intended to be an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary. As part of Aquestive’s employment process, final candidate will be required to complete a drug test and background check prior to employment commencing.

Please Note: Aquestive is a drug-free workplace and has a drug free workplace policy in place. Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

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