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Contract Pharmaceutical Quality Control Jobs in Indiana

At least 5 years of experience in pharmaceutical quality control, analytical development, or a related GMP laboratory function. * At least 1 year of experience as a laboratory supervisor, team lead ...

Quality Control Specialist Wanted at True Rx Health Strategists! Are you passionate about ensuring ... Our team of pharmacists and strategists delivers proven programs that find maximum savings and ...

Inspect fabricated members to ensure compliance with contract specifications, drawings, applicable ... Create, record, and maintain required Quality Control (QC) documentation. * Coordinate calibration ...

Quality Control Technician

Evansville, IN ยท On-site

$16.25 - $21/hr

Perform Quality Control Testing of Hot Mix Asphalt (HMA) and associated materials as assigned. * Assist in the review of contract documents and assist the QC/QA Lab Manager in preparing the ...

Quality Control Inspector Location: Indianapolis, IN Pay Rate: $24.55/hour Shift: Sunday through ... Foods and pharmaceutical experience is REQUIRED * Proven history of quality assurance in food and ...

Initiate quality procedures/documentation control for all new products and external contract vendors * Support new product introduction / scale-up and new raw material acquisition, as well as product ...

Perform Quality Control Testing of Hot Mix Asphalt (HMA) and associated materials as assigned. * Assist in the review of contract documents and assist the QC/QA Lab Manager in preparing the ...

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

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Contract Pharmaceutical Quality Control information

What is contract pharmaceutical quality control?

Contract Pharmaceutical Quality Control refers to the process where pharmaceutical companies outsource the testing and analysis of their products to third-party laboratories or service providers. These contract labs ensure that drug products meet regulatory standards for safety, efficacy, and quality before they reach the market. Services often include analytical testing, microbiological testing, method development, and stability studies. By outsourcing this work, companies can access specialized expertise and equipment, streamline operations, and maintain compliance with global regulations.

What are the key skills and qualifications needed to thrive as a contract pharmaceutical quality control specialist?

To thrive as a Contract Pharmaceutical Quality Control specialist, you need a strong background in chemistry, biology, or a related field, with experience in laboratory testing and quality assurance processes. Familiarity with analytical instruments such as HPLC, GC, and LIMS, as well as knowledge of regulatory standards like GMP and relevant certifications, is typically required. Attention to detail, problem-solving abilities, and strong communication skills are essential for accurate testing and effective collaboration. These skills and qualities ensure product safety, regulatory compliance, and the reliability of pharmaceutical products in a highly regulated industry.

What are some common challenges faced in a contract pharmaceutical quality control role and how can they be effectively managed?

In a Contract Pharmaceutical Quality Control role, professionals often navigate challenges such as tight project deadlines, varying client expectations, and strict regulatory requirements. Managing these challenges effectively involves clear communication with clients, thorough documentation, and staying updated with industry standards like GMP and FDA guidelines. Team collaboration is key, as projects typically involve coordination with analytical chemists, quality assurance specialists, and production staff. Adaptability and attention to detail are essential for ensuring both compliance and client satisfaction in a fast-paced, contract-based environment.

What is the difference between Contract Pharmaceutical Quality Control vs Contract Pharmaceutical Quality Assurance?

AspectContract Pharmaceutical Quality ControlContract Pharmaceutical Quality Assurance
Primary FocusTesting and analyzing drug samples to ensure quality and complianceDeveloping, implementing, and maintaining quality systems and procedures
Work EnvironmentLaboratories, testing facilities, manufacturing sitesOffice settings, quality management departments, regulatory agencies
Required CredentialsDegree in pharmacy, chemistry, or related field; certifications in lab testingDegree in pharmacy, chemistry, or related field; certifications in quality systems
Industry UsageUsed by pharmaceutical companies during product testing phasesUsed for ensuring overall quality compliance and regulatory adherence

Contract Pharmaceutical Quality Control focuses on testing and analyzing pharmaceutical products to verify quality, while Contract Pharmaceutical Quality Assurance emphasizes establishing and maintaining quality systems to ensure compliance. Both roles are essential in the pharmaceutical industry but serve different functions within the quality management process.

What are the most commonly searched types of Pharmaceutical Quality Control jobs in Indiana?

The most popular types of Pharmaceutical Quality Control jobs in Indiana are:

What are popular job titles related to Contract Pharmaceutical Quality Control jobs in Indiana?

For Contract Pharmaceutical Quality Control jobs in Indiana, the most frequently searched job titles are:

What job categories do people searching Contract Pharmaceutical Quality Control jobs in Indiana look for?

The top searched job categories for Contract Pharmaceutical Quality Control jobs in Indiana are:

Quality Control Supervisor

Orano

Brownsburg, IN โ€ข On-site

Full-time

This job post hasย expired today.ย Applications are no longer accepted.


Job description

Description
Orano Med, a subsidiary of Orano USA, is at the forefront of research in nuclear medicine and is developing new therapies against cancer. Based on its unique expertise in the extraction and purification of lead-212 (Pb-212) and radiolabeling technologies, Orano Med is developing innovative Pb-212-based treatments which consist of selectively destroying cancer cells while limiting the impact on surrounding healthy cells.
With a solid portfolio of development projects covering a diverse range of biological molecules capable of recognizing and targeting various forms of cancerous tumors, and a reliable supply chain for Pb-212, Orano Med aims to become a leader in targeted alpha therapies, in particular addressing needs of patients currently without effective therapeutic solutions among the existing approaches.
Position Summary
This is a working supervisor role. The individual is expected to learn, remain proficient in, and provide hands-on support for all assigned test methods, laboratory processes, and documentation practices. The Supervisor will set daily priorities, maintain a strong laboratory presence, and make timely operational and technical decisions.
The Supervisor will serve as a technical subject-matter expert and people leader. Responsibilities include analyst training, performance management, conflict resolution, laboratory investigations, and cross-functional communication. Success requires sound scientific judgment, strong technical writing and verbal communication, and calm decision-making under time-sensitive conditions.
Setup & Development Phase
  • Learn, perform, and maintain proficiency in all analytical test methods, laboratory processes, and controlled documentation practices within the assigned area.
  • Support analytical method development, optimization, qualification, validation, transfer, and lifecycle activities.
  • Establish training plans, qualification requirements, testing workflows, and clear expectations for compliant laboratory execution.
  • Support laboratory commissioning, instrument qualification, method readiness, staffing readiness, and analyst training.
  • Author and review protocols, reports, standard operating procedures, specifications, investigations, and other technical documents.
  • Provide scientific and operational input during process development, technology transfer, validation, and regulatory submission activities.

Production Phase
Top Priority: Execute and supervise QC testing for batch release within hours of production
Routine Functions - QC
  • Direct daily QC Chemistry laboratory operations, assign work, balance staffing, and ensure testing priorities are clearly understood.
  • Maintain hands-on capability and perform or directly support routine test methods when needed to protect testing timelines and product release.
  • Serve as the primary technical subject-matter expert for analytical methods, laboratory investigations, and complex technical issues.
  • Make timely laboratory decisions during testing and release, escalating significant quality, safety, or compliance risks appropriately.
  • Coordinate testing priorities with Manufacturing, Quality Assurance, Supply Chain, and other functions to meet production schedules.
  • Train, coach, and evaluate laboratory personnel; provide clear feedback, reinforce accountability, and resolve personnel conflicts promptly and fairly.
  • Maintain a visible leadership presence in the laboratory during critical testing, troubleshooting, and release operations.
  • Review analytical data, laboratory records, calculations, and results for accuracy, completeness, scientific validity, and compliance.
  • Lead laboratory investigations and corrective actions, and support inspections, audits, deviations, change controls, and CAPA activities.

Continuous Improvement
  • Evaluate method performance, laboratory trends, deviations, recurring issues, and workload data to identify improvement opportunities.
  • Lead root-cause analysis and ensure corrective actions address technical, procedural, and organizational causes.
  • Improve laboratory workflows, training systems, documentation quality, and inspection readiness while maintaining cGMP compliance.
  • Promote knowledge sharing, technical development, effective communication, and cross-functional collaboration.

Location: On-site 100%
This position may receive other responsibilities as needed.
Requirements
Qualifications
Education
Bachelor's degree in chemistry, analytical chemistry, pharmaceutical sciences, radiochemistry, or a related scientific discipline is required. A Master's degree is preferred.
Experience
  • At least 5 years of experience in pharmaceutical quality control, analytical development, or a related GMP laboratory function.
  • At least 1 year of experience as a laboratory supervisor, team lead, or technical lead with responsibility for directing personnel and work.
  • Direct experience supporting radiopharmaceutical drug testing is strongly preferred.
  • Strong knowledge of analytical method execution, qualification, validation, transfer, troubleshooting, and lifecycle management.
  • Experience in a GMP-regulated environment supporting clinical or commercial manufacturing.
  • Hands-on experience with techniques such as HPLC, GC, gamma spectroscopy, radio-TLC, dose calibrators, and related instrumentation.
  • Demonstrated technical writing, verbal communication, decision-making, coaching, and personnel conflict-resolution skills.

Skills
  • Strong laboratory presence, safety awareness, and hands-on technical leadership
  • Technical subject-matter expertise, scientific troubleshooting, and data review
  • Sound decision-making under time-critical conditions
  • Clear technical writing and effective verbal communication

  • Coaching, performance feedback, accountability, and personnel conflict resolution
  • Organization, prioritization, attention to detail, and urgency while maintaining cGMP standards

Other
  • Travel <10>
  • Lift 50 lbs.