Reporting to the Associate Director, Quality Control Stability and Trending, the Manager, Quality Control Operations will be responsible for day-to-day oversight of routine batch testing at contract ...
Reporting to the Associate Director, Quality Control Stability and Trending, the Manager, Quality Control Operations will be responsible for day-to-day oversight of routine batch testing at contract ...
Manager, Quality Control
Lenexa, KS · On-site
Managing the quality control operations, including the testing and inspection of products to ensure compliance with regulatory and quality standards. * Leading, training, and mentoring a team of ...
Manager, Quality Control
Lenexa, KS · On-site
Managing the quality control operations, including the testing and inspection of products to ensure compliance with regulatory and quality standards. * Leading, training, and mentoring a team of ...
Manager, Quality Control
Summerville, SC · On-site
The Manager, Quality Control is responsible for leading Thorne's Quality Control operations, ensuring the consistent delivery of safe, high-quality products through effective laboratory and ...
Manager, Quality Control
Summerville, SC · On-site
The Manager, Quality Control is responsible for leading Thorne's Quality Control operations, ensuring the consistent delivery of safe, high-quality products through effective laboratory and ...
Quality Control Manager
Lyndhurst, NJ · On-site
$85K - $95K/yr
Lead all quality control operations to ensure finished goods, components, and repaired merchandise ... Manage staffing, workload prioritization, and resource allocation to support business needs and ...
Quality Control Manager
Lyndhurst, NJ · On-site
$85K - $95K/yr
Lead all quality control operations to ensure finished goods, components, and repaired merchandise ... Manage staffing, workload prioritization, and resource allocation to support business needs and ...
Senior Manager, Quality Control
Rochester, MN · On-site
$117K - $160K/yr
The Senior Manager, Quality Control (QC) provides strategic, technical, and operational leadership for the Quality Control organization supporting radiopharmaceutical development and cGMP ...
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Senior Manager, Quality Control
Rochester, MN · On-site
$117K - $160K/yr
The Senior Manager, Quality Control (QC) provides strategic, technical, and operational leadership for the Quality Control organization supporting radiopharmaceutical development and cGMP ...
... and maintaining quality standards. You will work closely with internal teams and external ... best management practices for stormwater, erosion, and dust control suitable for the Southern ...
... and maintaining quality standards. You will work closely with internal teams and external ... best management practices for stormwater, erosion, and dust control suitable for the Southern ...
The Location Quality Control Manager is responsible for leading all quality assurance and quality control activities for precast and concrete manufacturing operations. This role ensures concrete ...
The Location Quality Control Manager is responsible for leading all quality assurance and quality control activities for precast and concrete manufacturing operations. This role ensures concrete ...
Be Seen First
Traffic Control Operations Manager
Nashville, TN · On-site
$22 - $28/hr
What You'll Do Field Operations • Set up and manage work zone traffic control in compliance with the MUTCD and Tennessee DOT standards • Flag and operate traffic control devices (signs, cones ...
New
Quick apply
Be Seen First
Traffic Control Operations Manager
Nashville, TN · On-site
$22 - $28/hr
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New
Quality Control Manager
Bexar, TX · On-site
$100K - $150K/yr
Quality Control Manager Summary of Position The Quality Control (QC) Manager is directly ... Review all QC issues with Operations at all stages of construction * Review close out processes to ...
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Quality Control Manager
Bexar, TX · On-site
$100K - $150K/yr
Quality Control Manager Summary of Position The Quality Control (QC) Manager is directly ... Review all QC issues with Operations at all stages of construction * Review close out processes to ...
QC Manager
Urbana, IL · On-site
The QC Manager at Evergreen Roadworks will oversee the quality control operations across multiple asphalt production facilities and field operations. This role is responsible for ensuring that all ...
QC Manager
Urbana, IL · On-site
The QC Manager at Evergreen Roadworks will oversee the quality control operations across multiple asphalt production facilities and field operations. This role is responsible for ensuring that all ...
QC Manager
Urbana, IL · On-site
The QC Manager at Evergreen Roadworks will oversee the quality control operations across multiple asphalt production facilities and field operations. This role is responsible for ensuring that all ...
QC Manager
Urbana, IL · On-site
The QC Manager at Evergreen Roadworks will oversee the quality control operations across multiple asphalt production facilities and field operations. This role is responsible for ensuring that all ...
Quality Assurance & Quality Control Manager
$100K - $150K/yr
Manage Quality Control operations, including incoming, in-process, and final inspections, ensuring timely product release and compliance with established procedures. * Review inspection records and ...
New
Quick apply
Quality Assurance & Quality Control Manager
$100K - $150K/yr
Manage Quality Control operations, including incoming, in-process, and final inspections, ensuring timely product release and compliance with established procedures. * Review inspection records and ...
New
The Quality Control Manager (QC Operations) leads Incoming Inspection, In-Process Inspection, Final Inspection, and Quality Laboratory functions while partnering closely with New Product Development ...
The Quality Control Manager (QC Operations) leads Incoming Inspection, In-Process Inspection, Final Inspection, and Quality Laboratory functions while partnering closely with New Product Development ...
Quality Control Supervisor
Waukesha, WI · On-site
Quality Control Supervisor About Walbec Group Walbec produces high-quality construction materials ... Continued education under the direction of the Technical Operations Manager to be a compliance ...
Quality Control Supervisor
Waukesha, WI · On-site
Quality Control Supervisor About Walbec Group Walbec produces high-quality construction materials ... Continued education under the direction of the Technical Operations Manager to be a compliance ...
Daily QC Operations - Oversee inspections at all stages: receiving, pre-treatment, kettle, and post ... tanks. - Manage nonconformance reports and drive corrective actions. Audit & Customer Support ...
Daily QC Operations - Oversee inspections at all stages: receiving, pre-treatment, kettle, and post ... tanks. - Manage nonconformance reports and drive corrective actions. Audit & Customer Support ...
Manager, CQV Quality Control
Cranbury, NJ · On-site
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Manager, CQV Quality Control
Cranbury, NJ · On-site
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... lifecycle management. The QC Head partners closely with site and global stakeholders to drive operational excellence, harmonization, and continuous improvement, while ensuring alignment with ...
... lifecycle management. The QC Head partners closely with site and global stakeholders to drive operational excellence, harmonization, and continuous improvement, while ensuring alignment with ...
(USA) Area Manager, Quality Control
Cleburne, TX · On-site
$65K - $98K/yr
Oversees operational audits, including shipping, HACCP, meat, and banana audits. Accurately and effectively communicates standards and expectations around performance metrics to QC team members.
(USA) Area Manager, Quality Control
Cleburne, TX · On-site
$65K - $98K/yr
Oversees operational audits, including shipping, HACCP, meat, and banana audits. Accurately and effectively communicates standards and expectations around performance metrics to QC team members.
Quality Control Manager
Charles City, IA · On-site
Manages all Biological Quality Control Operations for the Charles City site to ensure all vaccines meet US, EU and International regulatory requirements. Advise Management of products not meeting ...
Quality Control Manager
Charles City, IA · On-site
Manages all Biological Quality Control Operations for the Charles City site to ensure all vaccines meet US, EU and International regulatory requirements. Advise Management of products not meeting ...
Quality Control Manager
Charles City, IA · On-site
Manages all Biological Quality Control Operations for the Charles City site to ensure all vaccines meet US, EU and International regulatory requirements. Advise Management of products not meeting ...
Quality Control Manager
Charles City, IA · On-site
Manages all Biological Quality Control Operations for the Charles City site to ensure all vaccines meet US, EU and International regulatory requirements. Advise Management of products not meeting ...
Quality Control Operations Manager information
See salary details
$30.5K - $39.5K
5% of jobs
$39.5K - $48.5K
5% of jobs
$48.5K - $57.5K
11% of jobs
$60.3K is the 25th percentile. Wages below this are outliers.
$57.5K - $66.5K
13% of jobs
$66.5K - $75.5K
14% of jobs
The median wage is $77.5K / yr.
$75.5K - $84.5K
12% of jobs
$84.5K - $93.5K
13% of jobs
$96.4K is the 75th percentile. Wages above this are outliers.
$93.5K - $102.5K
11% of jobs
$102.5K - $111.5K
7% of jobs
$111.5K - $120.5K
5% of jobs
$120.5K - $129.5K
5% of jobs
$30.5K
$81.3K
$129.5K
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Re-posted 29 days ago
Job description
Reporting to the Associate Director, Quality Control Stability and Trending, the Manager, Quality Control Operations will be responsible for day-to-day oversight of routine batch testing at contract and internal Kiniksa testing laboratories. This individual will be responsible for sample management, data review, management of reference standards, critical reagents, certificate of analysis generation and delivery of QC results. This role will collaborate with internal/external, multidisciplinary teams and external partners.
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):
- Support Kiniksa's Quality Control programs for commercial and late-stage clinical drug products, including combination products
- Responsible for GMP reference standards including leading the qualification, requalification and inventory management across all laboratories
- Participate on analytical teams to proactively support GMP routine operations
- Coordinate shipping and sample management for all routine testing activities
- Partner with contract testing labs to support routine release testing activities and ensure on time delivery of all batch testing including in-process, drug substance and drug product testing
- Drive the timely completion of Quality System records associated with sample testing to improve reliability of test methods, facilitate change, and evaluate and prevent exceptions (change control, deviations, and CAPAs)
- Author, review and approve related QC protocols, reports, and data.
- Review and approve laboratory data and results, assuring their traceability and integrity
- Generate Certificates of Analysis for product release, and other certificates of GMP testing
- Coordinate testing of Kiniksa samples at intern/external testing laboratories
- Review, approve stability data, protocols, and reports as needed
- Assure availability of critical reagents and other essential materials
- Manage GMP reserve sample program
- Drive process improvements and ensure inspection readiness (ISO, GMP alignment) for area of responsibility
- Manage SOW and contracts for areas of responsibility
- Participate in budget, track KPI metrics and additional tasks as required.
Stand Out Skills for Impact:
- Strong expertise in GMP Quality Control operations for biologics, overseeing batch release testing, sample management, and data review to ensure product quality and compliance
- Proven ability to manage end-to-end laboratory operations, including reference standards, critical reagents, stability programs, and coordination with internal labs and external CMOs
- Deep knowledge of quality systems and compliance (deviations, CAPAs, change control), driving data integrity, traceability, and continuous improvement in QC processes
- Effective cross-functional collaborator skilled in partnering with contract labs and internal teams, ensuring on-time delivery of testing, KPI performance, and inspection readiness
Qualifications and Experience:
- 5+ years experience in Quality Control in GMP setting. Experience in biologics required
- BS in analytical chemistry, microbiology or related life sciences field
- Experience in routine GMP QC operations including reference standard management and review/release of QC testing data
- Knowledge of analytical methodologies common for biologics analysis in addition to compendial testing.
- Proven ability to manage projects and work with cross-functional teams comprised of internal and/or external contacts, including CMOs
- Demonstrated strong written and verbal communication skills
- Proven mindset of proactive continuous improvement
- Efficient independent worker with ability to focus and drive for results
- Strong organizational skills and attention to detail
- Ability to work in a fast paced-environment and to handle multiple tasks
- Strong commitment to compliance and ethical standards
- Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
- Ability to travel up to [5%]
About Kiniksa Pharmaceuticals
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
201 - 500 Employees
Headquarters location
Lexington, MA, US
Year founded
2015