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Quality Control Stability Jobs in Washington (NOW HIRING)

Granules

Quality Control Manager

Chantilly, VA · On-site

Supervise the testing of bulk release, finished product and stability testing * Manage and supervise QC laboratory personnel with varying levels of experience, assigning the work schedule and ensure ...

Harris

QA + QC Manager

Bethesda, MD · On-site

$95.35K - $143.02K/yr

The purpose of your role as a QA + QC Manager is to Manage and implement various quality assurance ... the stability, resources and opportunities of a national company, and the team culture, creative ...

ResolveSoft Inc

Be Seen First

Senior QA/QC Analyst

Washington, DC · On-site

$90K - $105K/yr

ResolveSoft is seeking a highly motivated Senior QA/QC Analyst (Remote) to join our growing team ... You will ensure the stability of the software by conducting regression testing after code changes ...

AstraZeneca

Director Product Quality Leader

Rockville, MD · On-site

$167.60K - $251.39K/yr

Develop and implement the overallProduct Quality Strategyand phase-appropriate control strategies * Ownandmaintainlot release and stability specifications for advanced cell therapy modalities

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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.

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What job categories do people searching Quality Control Stability jobs in Washington look for? The top searched job categories for Quality Control Stability jobs in Washington are:
What cities in Washington are hiring for Quality Control Stability jobs? Cities in Washington with the most Quality Control Stability job openings:
Quality Control Stability jobs near you

Quality Control Manager

Granules Pharmaceuticals

Chantilly, VA • On-site

Full-time

Posted 10 days ago

Job description

Supervise the work of laboratory personnel engaged in performing routine finished product testing & stability testing, including planning laboratory work, evaluating work performed and handling procedural and technical laboratory problems. Execute according to high standards of quality at the lab through managing and continuously improving the effectiveness of laboratory quality processes and systems
Job Duties & Responsibilities
  • Supervise the testing of bulk release, finished product and stability testing
  • Manage and supervise QC laboratory personnel with varying levels of experience, assigning the work schedule and ensure assigned tasks are performed.
  • Review of test results for accuracy and proper documentation.
  • Review of specifications and STMs for in process and finished products.
  • Write OOS investigations, including finding root cause and corrective/preventive actions.
  • Supervise lab processes, including timely management of investigations, CAPA implementation to ensure sustainable compliance
  • Review of SOPs, lab related investigations, stability failure notifications, COAs, and compilation of stability related data. Responsible for timely release of in-process, finished product release COA's
  • Monitor and report the trends in bulk, finished products, and stability samples to QC/QA Management
  • Review of IQ, OQ, and PQ for new instruments, protocols/reports
  • Responsible for coordinating with other departments like warehouse, QA, Maintenance, purchase department, R&D in day to day activity for better operational requirements and to follow the cGMP requirements.
  • Responsible for the coordination of sample management, not limited to in-process, finished product and stability samples.
  • Monitor Quality Control, Safety and cGMP practices to assure compliance with internal and external regulations.
  • Perform other related duties as assigned to meet departmental and Company objectives.

Management Responsibility
  • Manage group of scientists.

Reports to
  • Associate Director / Director

Requirements
Knowledge & Skills
  • Ability to maintain integrity and honesty at all times
  • Ability to communicate and lead with transparency
  • Accountable for performance and results of department
  • Ability to assume additional responsibilities on own initiative.

Experience & Education
  • Requires minimum BA/BS in Biochemistry, Chemistry or related field with 10-15 years' experience in the biotech or pharmaceutical industry. Management experience in Quality Control required MS/MA.

Physical Requirements/Working Environment
  • Regular Laboratory environment with lab coats, safety glasses, 4-6hrs/day of standing while performing chemical test and able to stand for 4-6hrs/day.

Travel
  • No Travel requirement.

Disclaimer
The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.

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