Reporting to the Associate Director, Quality Control - Stability and Trending, the Stability Coordinator manages the GMP stability programs, supporting trending of methods, reference standard, and ...
Reporting to the Associate Director, Quality Control - Stability and Trending, the Stability Coordinator manages the GMP stability programs, supporting trending of methods, reference standard, and ...
This position is critical for supporting batch release, stability studies, environmental monitoring, method validation, and device testing. In addition to data review, this role will support QC data ...
This position is critical for supporting batch release, stability studies, environmental monitoring, method validation, and device testing. In addition to data review, this role will support QC data ...
This position is critical for supporting batch release, stability studies, environmental monitoring, method validation, and device testing. In addition to data review, this role will support QC data ...
This position is critical for supporting batch release, stability studies, environmental monitoring, method validation, and device testing. In addition to data review, this role will support QC data ...
Quality Control Specialist
Lexington, MA · On-site
$72K - $91K/yr
Reporting to the Associate Director, Quality Control - Stability and Trending, the Stability Coordinator manages the GMP stability programs, supporting trending of methods, reference standard, and ...
Quality Control Specialist
Lexington, MA · On-site
$72K - $91K/yr
Reporting to the Associate Director, Quality Control - Stability and Trending, the Stability Coordinator manages the GMP stability programs, supporting trending of methods, reference standard, and ...
Director, Quality Control
Waltham, MA · On-site
The Director, Quality Control leads global Quality Control activities, including oversight of external laboratories supporting analytical testing, release, and stability programs across clinical and ...
Director, Quality Control
Waltham, MA · On-site
The Director, Quality Control leads global Quality Control activities, including oversight of external laboratories supporting analytical testing, release, and stability programs across clinical and ...
Director, Quality Control
Waltham, MA · On-site
The Director, Quality Control leads global Quality Control activities, including oversight of ... Authors, reviews, and approves stability protocols and reports and supports assignment of product ...
Director, Quality Control
Waltham, MA · On-site
The Director, Quality Control leads global Quality Control activities, including oversight of ... Authors, reviews, and approves stability protocols and reports and supports assignment of product ...
Associate Director, Quality Control
Waltham, MA · Hybrid
$160K - $200K/yr
Manage phase appropriate stability, specification and reference standard programs in support of early and late-stage products * Serve as QC point of contact for CDMOs/CTLs ensuring appropriate ...
Associate Director, Quality Control
Waltham, MA · Hybrid
$160K - $200K/yr
Manage phase appropriate stability, specification and reference standard programs in support of early and late-stage products * Serve as QC point of contact for CDMOs/CTLs ensuring appropriate ...
This individual will also lead stability transfers of products including sample chain of custody ... The Sr. Manager, QC is accountable for regulatory inspection interactions related to analytical ...
This individual will also lead stability transfers of products including sample chain of custody ... The Sr. Manager, QC is accountable for regulatory inspection interactions related to analytical ...
Manage phase appropriate stability, specification and reference standard programs in support of early and late-stage products * Serve as QC point of contact for CDMOs/CTLs ensuring appropriate ...
Quick apply
Manage phase appropriate stability, specification and reference standard programs in support of early and late-stage products * Serve as QC point of contact for CDMOs/CTLs ensuring appropriate ...
Associate Director, Quality Control
Waltham, MA · On-site
$160K - $200K/yr
Manage phase appropriate stability, specification and reference standard programs in support of early and late-stage products * Serve as QC point of contact for CDMOs/CTLs ensuring appropriate ...
Associate Director, Quality Control
Waltham, MA · On-site
$160K - $200K/yr
Manage phase appropriate stability, specification and reference standard programs in support of early and late-stage products * Serve as QC point of contact for CDMOs/CTLs ensuring appropriate ...
Director, Quality Control Contractor
Boston, MA · Remote
$95 - $120/hr
Description of Role The Director, Quality Control (contractor) will provide leadership and ... Stability Program Leadership * Oversee the stability program design and execution across multiple ...
Director, Quality Control Contractor
Boston, MA · Remote
$95 - $120/hr
Description of Role The Director, Quality Control (contractor) will provide leadership and ... Stability Program Leadership * Oversee the stability program design and execution across multiple ...
This individual will also lead stability transfers of products including sample chain of custody ... The Sr. Manager, QC is accountable for regulatory inspection interactions related to analytical ...
This individual will also lead stability transfers of products including sample chain of custody ... The Sr. Manager, QC is accountable for regulatory inspection interactions related to analytical ...
Director, Quality Control Contractor
Boston, MA · On-site
$95 - $120/hr
Description of Role The Director, Quality Control (contractor) will provide leadership and ... Stability Program Leadership * Oversee the stability program design and execution across multiple ...
Director, Quality Control Contractor
Boston, MA · On-site
$95 - $120/hr
Description of Role The Director, Quality Control (contractor) will provide leadership and ... Stability Program Leadership * Oversee the stability program design and execution across multiple ...
Quality Control Analyst II, Release & Stability Testing (3rd Shift - Contract)
Milford, MA · On-site
$39 - $46/hr
The Quality Control Analyst II, Release and Stability Testing is responsible for the cGMP analytical testing of stability samples and evaluation of data to ensure compliance with analytical methods ...
Quality Control Analyst II, Release & Stability Testing (3rd Shift - Contract)
Milford, MA · On-site
$39 - $46/hr
The Quality Control Analyst II, Release and Stability Testing is responsible for the cGMP analytical testing of stability samples and evaluation of data to ensure compliance with analytical methods ...
The Quality Control Analyst II, Release and Stability Testing is responsible for the cGMP analytical testing of stability samples and evaluation of data to ensure compliance with analytical methods ...
The Quality Control Analyst II, Release and Stability Testing is responsible for the cGMP analytical testing of stability samples and evaluation of data to ensure compliance with analytical methods ...
Provide governance and oversight for QC systems including specifications, test methods, environmental monitoring, stability programs, reference standards, and batch release support. * Ensure QC ...
Quick apply
Provide governance and oversight for QC systems including specifications, test methods, environmental monitoring, stability programs, reference standards, and batch release support. * Ensure QC ...
... QC operation ... The successful candidate will be responsible for leading a team performing release, stability ...
New
... QC operation ... The successful candidate will be responsible for leading a team performing release, stability ...
New
Vice President, Quality Control
Needham, MA · On-site
$290K - $335K/yr
Provide governance and oversight for QC systems including specifications, test methods, environmental monitoring, stability programs, reference standards, and batch release support. * Ensure QC ...
Vice President, Quality Control
Needham, MA · On-site
$290K - $335K/yr
Provide governance and oversight for QC systems including specifications, test methods, environmental monitoring, stability programs, reference standards, and batch release support. * Ensure QC ...
... QC operation ... The successful candidate will be responsible for leading a team performing release, stability ...
New
... QC operation ... The successful candidate will be responsible for leading a team performing release, stability ...
New
QC Analyst
Devens, MA · On-site
$26.75 - $36/hr
Quality Control Analyst Location: Devens, MA Duration: 6 Months(extension up to 3 year) QC ... Routine testing and data review of batch release and stability samples of Bulk Drug Substance and ...
QC Analyst
Devens, MA · On-site
$26.75 - $36/hr
Quality Control Analyst Location: Devens, MA Duration: 6 Months(extension up to 3 year) QC ... Routine testing and data review of batch release and stability samples of Bulk Drug Substance and ...
Quality Control Stability information
See Acton, MA salary details
$33.6K - $43.5K
5% of jobs
$43.5K - $53.4K
5% of jobs
$53.4K - $63.3K
11% of jobs
$66.4K is the 25th percentile. Wages below this are outliers.
$63.3K - $73.2K
13% of jobs
$73.2K - $83.1K
14% of jobs
The median wage is $85.4K / yr.
$83.1K - $93K
12% of jobs
$93K - $102.9K
13% of jobs
$106.2K is the 75th percentile. Wages above this are outliers.
$102.9K - $112.9K
11% of jobs
$112.9K - $122.8K
7% of jobs
$122.8K - $132.7K
5% of jobs
$132.7K - $142.6K
5% of jobs
$33.6K
$89.5K
$142.6K
How much do quality control stability jobs pay per year?
What is a quality control stability role?
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What are the key skills and qualifications needed to thrive as a quality control stability specialist, and why are they important?
What is the difference between Quality Control Stability vs Quality Control Inspector?
| Aspect | Quality Control Stability | Quality Control Inspector |
|---|---|---|
| Certifications | Often requires certifications like Six Sigma, ISO auditor, or quality management certifications | Typically requires quality inspection certifications or training |
| Work Environment | Focuses on maintaining process stability in manufacturing or production settings | Performs inspections on products or materials on the production line |
| Employer & Industry Usage | Used in manufacturing, aerospace, automotive, and industries emphasizing process consistency | Common 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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Cities near Acton, MA with the most Quality Control Stability job openings:
Quality Control Specialist
Lexington, MA
Full-time
Posted 26 days ago
Job description
Reporting to the Associate Director, Quality Control - Stability and Trending, the Stability Coordinator manages the GMP stability programs, supporting trending of methods, reference standard, and stability data to improve process and product understanding, and to support problem solving and decision making. The successful candidate will support clients across Kiniksa, including Analytical Development, Quality Control, Manufacturing, CMC, Validation, and Quality Systems.
This role is based in our Lexington, MA office and requires employees to be onsite five days per week.
Responsibilities (including, but not limited to):
- Oversee systems supporting GMP stability programs including tracking and trending of stability data, generation of protocols and reports, and driving timely completion of quality records
- Maintain stability testing records and results within the stability software to assure traceability and availability of records
- Collaborate with contract laboratories to ensure timely completion of testing and delivery of QC deliverables for stability programs
- Review and approve laboratory data and results, ensuring their traceability and integrity
- Generate and present stability metrics to support annual reports, regulatory filings, and internal decision-making
- Perform routine trending of stability data to support shelf-life of GMP products
- Evaluate product stability data to establish and extend product shelf-life
- Coordinate shipping and sample management of routine and non-routine testing activities
- Drive process improvements and ensure inspection readiness (ISO, GMP alignment) for area of responsibility
- Create and improve procedures related to GMP stability programs
- Support batch certificate and Certificates of Analyses generation and additional tasks as required
- Participate in the authoring and review of QC protocols and stability reports
Standout Skills for Impact:
- Proven ability to manage projects and work with cross-functional teams comprised of internal and/or external contacts, including CTLs
- Proactive, with a strong desire to engage with clients, and act with urgency and passion
- Strong ownership mindset with the ability to drive timelines and resolve issues in collaboration with internal teams and external partners
- Ability to translate stability data and trends into clear insights that support decision-making, regulatory strategy, and product lifecycle management
Qualifications and Experience:
- BS in a scientific area with 3-5 years of experience in Quality Control in a GMP setting
- Working knowledge of statistical tools, methodologies, and related software, including experience with JMP as a plus
- Experience working with contract testing laboratories or external vendors in a regulated environment
- Ability to review analytical data for completeness, accuracy, traceability, and compliance with applicable procedures
- Effective verbal and written communication skills
- Proven ability to work with a high level of integrity, accuracy, and attention to detail
- Familiarity with ICH stability guidelines and expectations for pharmaceutical products
- Knowledge of quality systems and domestic and international regulatory requirements
About Kiniksa Pharmaceuticals
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
201 - 500 Employees
Headquarters location
Lexington, MA, US
Year founded
2015