Top 232 Quality systems specialist Jobs in Frederick Md

Sr QA Specialist
Kite Pharma —Frederick, MD
- $123,930 - $160,380 a year
- Full-time
- 5 years
- Bachelor of Science
- Analysis skills
- Health insurance
- Dental insurance
Lab Ops Specialist I
Kite Pharma —Frederick, MD
- $69,445 - $89,870 a year
- Overnight shift
- Mid-level
- Continuous improvement
- Associate's degree
- Health insurance
- Dental insurance
13d
IT Service Desk Support Specialist
Music & Arts —Frederick, MD
- $68,000 - $90,000 a year
- Email
- Hybrid work
- Microsoft Excel
- Microsoft Outlook
- Mid-level
- Paid holidays
- Health insurance
Quality & Sustainability Specialist
Flow Control Group —Frederick, MD
- $70,000 - $90,000 a year
- Full-time
- Mid-level
- 3 years
- Administrative experience
- Paid holidays
- Health insurance
Quick Apply
IT Specialist 1/IT Support Assistant, 2
Telos Corporation —Frederick, MD
- Full-time
- Customer service
- High school diploma or GED
- Driver's License
- Health insurance
- Dental insurance
Administrative Specialist I (Part Time)
Frederick County Government —Frederick, MD
- $23.87 an hour
- Part-time
- Ability to walk for extended periods
- Word processing
- Computer literacy
- Disability insurance
- Health insurance
1d
Inventory Specialist
Wine Districts —Frederick, MD
- From $22 an hour
- Part-time
- Analysis skills
- In-person
- 1 year
- Employee discount
Quick Apply
6d
Data Center Logistics Manager
Amazon Data Services, Inc. —Frederick, MD
- $65,000 - $113,800 a year
- Full-time
- Microsoft Word
- Mid-level
- High school diploma or GED
- AD&D insurance
- Health insurance
13d
Payment Integrity Specialist
GeneDx —Gaithersburg, MD
- $70,000 - $86,000 a year
- Remote
- Mid-level
- 3 years
- Finance
13d
Procurement Specialist (Entry Level)
RCI Custom —Frederick, MD
- $18 - $20 an hour
- Full-time
- Background check
- Microsoft Outlook
- ERP systems
- Paid holidays
- Health insurance
Quick Apply
Technical Implementation Specialist I
NCR —Germantown, MD
- $65,100 - $97,700 a year
- Weekends as needed
- English
- Mid-level
- Windows
- Disability insurance
- Dental insurance
Facilities Systems Specialist II (#1906)
Battelle National Biodefense Inst —Fort Detrick, MD
- $74,220.83 - $122,625.72 a year
- Full-time
- Mid-level
- High school diploma or GED
- Ability to lift 50 pounds
Quick Apply
Job Development Specialist
Frederick County Government —Frederick, MD
- $53,145.77 - $90,347.81 a year
- Email
- Word processing
- Urgent Care
- Pass drug screening
- Wellness program
- Health savings account
1d
Lead IT Specialist (CustSpt)
US National Institutes of Health —Montgomery County, MD
- $102,415 - $133,142 a year
- Online Application
- Remote
- Background check
- Pass drug screening
- Travel
4h
QA Calibration Specialist
Frederick National Laboratory —Frederick, MD
- $49,200 - $72,439 a year
- Full-time
- Writing skills
- No experience needed
- Mid-level
- COVID-19 protective measures
Inpatient Coder - Full-time with Benefits
Frederick Health —Frederick, MD
- $26.46 - $37.80 an hour
- Overtime
- Anatomy knowledge
- Surgery
- 5 years
- Disability insurance
- Health insurance
Quick Apply
Customer Support Specialist
JLG —Hagerstown, MD
- $51,400 - $79,200 a year
- Full-time
- Marketing
- ERP systems
- Research
Database Sustainment Specialist (DSS) - Ft Detrick USAMRIID
Na Ali'i Consulting & Sales, LLC. —Fort Detrick, MD
- $55,000 - $65,000 a year
- Full-time
- 5 years
- Mid-level
- Bachelor's degree
1d
Communications Specialist
RIVA Solutions Inc. —Fort Detrick, MD
- $105,000 a year
- Full-time
- Mid-level
- Office
- Bachelor's degree
- Wellness program
- Health savings account
Quick Apply
7d
Quality Assurance Specialist (GCP/GLP)
Pharmaron —Germantown, MD
- Full-time
- Mid-level
- Bachelor's degree
- Communication skills
Quick Apply

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Sr QA Specialist

Kite Pharma -
Frederick, MD

Apply Now

Job Details

Full-time
$123,930 - $160,380 a year

Benefits

Health insurance
Dental insurance
Paid time off
Vision insurance
Life insurance

Qualifications

Pharmaceutical manufacturing facility experience

Full Job Description

Job Description

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.

Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.

Job Description

Specific Job Responsibilities:

Work with the Commercial Manufacturing, Quality Control, Materials Management and
Facilities/Engineering departments as a Quality Assurance representative.
Coordinate and facilitate Quality Assurance related production and production related activities, including:
Approval of electronic batch records and manufacturing labels.
Assessment and closure of discrepancies, deviations, CAPAs and change controls requests.
Completion of change actions for change controls.
Assessment and closure of laboratory investigations.
Timely assessment and closure of batch and material hold events.
Communicate lot review pending issues to management.
Review and disposition of batch manufacturing documentation for timely disposition of final product.
Ensure products are manufactured in compliance with Kite specifications, regulatory and GMP guidelines.
Support development of SOPs and review/approve SOPs to ensure quality objectives are met.
Review and approve test methods, manufacturing/quality control qualification/validation protocols and reports.
Review and approve manufacturing production records.
Review and disposition of raw materials.
Review and compile all batch related documents into a final product lot disposition package.
Perform/review and approve quality investigations of manufacturing deviations, GMP and quality system issues, non-conforming materials, and CAPAs.
Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues.
Manage day-to-day activities for the initiation, tracking, and closure of non-conformances and CAPAs.
Provide periodic updates to management for deviations, GMP and system issues, non-conforming materials and products and CAPAs.
Review and disposition raw materials, media/reagents, components, and labels for GMP use.
Review and approve proposed changes to systems, procedures, methods, and submissions to regulatory agencies.
Gather metric information for use in continuous improvement of areas of responsibility. Report to management as needed.
Manage and participate in internal, external and regulatory inspections and audits.
Participate in continuous improvement projects.
May serve as a team representative on cross-functional projects to support more senior colleagues in the function.
Acts as a mentor to junior staff.
Provide process training to team, as needed.
These duties can be delegated to designated deputies of a satisfactory qualification level as needed.

Knowledge:

Proficient in GMPs and/or GLPs.
Proficient in application of QA principles, concepts, industry practices, and standards.
Demonstrates ability to effectively manage multiple projects/priorities.
Has proven analytical and conceptual skills.
Demonstrates understanding of international quality systems regulations to adopt best in class systems/processes
Demonstrates excellent verbal communication, technical writing and interpersonal skills.
Demonstrates working knowledge and good proficiency in Microsoft Office applications.
Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical methods are beneficial.
Working knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)) is beneficial.

Basic Qualifications:

7+ years of relevant experience in a GMP environment related field and a BS/BA.

5+ years of relevant experience and a MS.

The salary range for this position is: $123,930.00 - $160,380.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Kite Pharma Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.

Apply Now

Refine Your Search

quality systems specialist jobs in frederick md

Sr QA Specialist

Lab Ops Specialist I

IT Service Desk Support Specialist

Quality & Sustainability Specialist

IT Specialist 1/IT Support Assistant, 2

Administrative Specialist I (Part Time)

Inventory Specialist

Data Center Logistics Manager

Payment Integrity Specialist

Procurement Specialist (Entry Level)

Technical Implementation Specialist I

Facilities Systems Specialist II (#1906)

Job Development Specialist

Lead IT Specialist (CustSpt)

QA Calibration Specialist

Inpatient Coder - Full-time with Benefits

Customer Support Specialist

Database Sustainment Specialist (DSS) - Ft Detrick USAMRIID

Communications Specialist

Quality Assurance Specialist (GCP/GLP)

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