- Maintain and update the Clinical Trial Quality Management system to be current with industry standards, guidance, and best practices.
- Contributes to the development and review of SOPs and other controlled documents (forms, templates, work instructions).
- Ensures compliance with SOPs and ICH GCP E6 (R2) standards.
- Manages the incident management program through monitoring of complaints, deviations and CAPAs.
- Schedules, plans, coordinates, and conducts vendor/supplier audits, internal audits, compliance visits, for cause audits and clinical trial site audits.
- Prepares required documentation to support audit activities including audit plans, audit reports, audit certificates and corrective action plans
- Validates accuracy of audit findings, a written audit report and follow-up activities to assure that non-compliance issues are addressed with satisfactory resolution.
- Reviews the final audit documents for accuracy.
- Review trial related documents e.g. protocols, protocol amendments, ICFs, pharmacy manuals and CSRs
- Apply regulations, guidance document requirements, and study protocol requirements to clinical trial studies.
- Participate in solving GCP compliance issues within Quality Assurance, Clinical Operations, Regulatory Affairs, Medical Affairs, and Pharmacovigilance.
- Support joint efforts in training on company procedures, GCP regulations, and documentation systems to assure compliance with company policies and regulatory standards.
- Maintain all associated QA department spreadsheets tracking of deviations, CAPAs, complaints, audit findings, and audit files as applicable.
- Lead development and implementation efforts for inspection readiness at all times.
- Assists senior staff during regulatory inspections or other audits.
- Represents QA department at internal and external meetings supporting clinical programs.
- Performs other Quality related duties, as assigned.
- Bachelor's Degree in a life sciences or engineering discipline with a minimum of 7 years of experience in a GCP-Biologics or Pharmaceutical environment; or Master's degree in a life sciences or engineering discipline with a minimum of 4 years' of experience in a GCP-Biologics or Pharmaceutical environment.
- CQA or other audit certifications are a plus.
- Prior TMF or electronic document management systems experience is a plus.
- Ability to effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines
- Strong problem solving and analytical skills with demonstrated ability to be detail-oriented, while managing multiple projects simultaneously.
- Demonstrated understanding and application of ICH GCP E6 (R2)
- Proficient in communication both verbal and written
- Multitasks across multiple functional areas
- Timeline focused and flexible in their work scheduling to meet the demands of a multi-product clinical phase pharmaceutical company.
- This is a hybrid role required to work on site 2-3 times per week
- Flexibility in working schedule, i.e., off-hours, second shift, weekends
- 25%-30% travel may be required
-
Pharmaceutical Quality Assurance
1 day ago
Fladger Associates El Segundo, United StatesResponsibilities: · - Excellent employment opportunity for a QA Specialist - III in the El Segundo, CA area. · - Will participate in Quality activities to ensure compliance with applicable quality objectives and regulatory requirements. · - Report into the Sr. QA Manager, Quality ...
-
Quality Assurance Technician
1 week ago
Operio Group Gardena, United States**Are you looking for a team that cares about you?** · Vivion Inc. - an Operio Group Company is a growing international company with 60 years of experience in the ingredients and consumable sectors that puts their team first so we can provide excellent solutions to our customers. ...
-
Quality Assurance
1 week ago
Prime Home Health Burbank, United StatesHome Health QA (Quality Assurance) · Immediate opening for experience Home Health QA (Quality Assurance) to work in the office full time Monday to Friday. Must be detailed oriented and perform quality management on each patients chart and can handle load of work on day to day bas ...
-
Quality Assurance
1 day ago
The Help Group Van Nuys, United States**F**ounded in 1975, The Help Group is the largest**, most innovative and comprehensive nonprofit of its kind in the United States serving children with special needs related to autism spectrum disorder, ADHD, learning disabilities, developmental delays, abuse and emotional probl ...
-
Quality assurance
1 week ago
Sapphire Solutions Garden, United StatesWe are a successful, globally active company in pipe connection technology and manufacture high-quality products for various industries with approximately 380 employees in 18 subsidiaries. Schwer Fittings is committed to developing solution strategies together with the customer t ...
-
Quality Assurance Tech
1 week ago
FTR Staffing LLC Paramount, United StatesJoin Our Team · We are seeking a dedicated and experienced Quality Assurance Technician for a food manufacturing company. · **JOB RESPONSIBILITIES**: · - Develop and implement QA policies and procedures to meet regulatory standards and customer requirements. · - Conduct inspectio ...
-
Quality Assurance Technician
1 week ago
Reyes Coca-Cola Bottling Los Angeles, United StatesOverview: · Reyes Coca-Cola Bottling is a proud West Coast and Midwest bottler and distributor of Coca-Cola brands. We deliver Coca-Cola products to restaurants, sporting venues, businesses, healthcare facilities, schools, convenience stores and supermarkets. We work with iconic ...
-
Quality Assurance Nurse
1 week ago
Pursue Health LLC Los Angeles County, CA, United States**Job Title: Quality Assurance Nurse (RN)** · **Location**:Los Angeles County** · **Company**: Pursue Health, LLC · **About Us**: Pursue Health provides consulting and administrative services to · various sectors within the healthcare industry to promote operation efficiency, · a ...
-
Quality Assurance Manager
1 week ago
MV Transportation Los Angeles, United StatesOverview: · If you reside in California, please see our California Applicant Privacy Policy for more information about our data handling practices and your data rights. · **Responsibilities**: · MV Transportation is seeking a **Quality Assurance Manager** to ensure that all passe ...
-
Quality Assurance Technician
18 hours ago
Sterile Processing Services of America Long Beach, United StatesAssist Quality Assurance Supervisor with the duties of quality assurance technician to include implementation and enforcement of the **SPSA Quality Policy** **and Procedures** at SPSA processing facility. · **POSITION RESPONSIBILITIES**: · - Ensure quality control functions are p ...
-
Specialist, Quality Assurance
1 week ago
Call the Car Pasadena, United StatesWe are currently expanding our team and looking for a **Quality Assurance Specialist** to join us. If you're passionate about healthcare and making a difference in people's lives, this is the job for you · **BASIC JOB PURPOSE**:Quality Assurance Specialist is responsible for inve ...
-
Lvn Quality Assurance
2 days ago
Excell Home Care, Inc. Paramount, United States**JOB DESCRIPTION** · **Summary/Objective** · The LVN Quality Assurance receives patient visit documentation submitted by field staff and reviews the documents for timeliness, completeness, and accuracy. · **Essential Functions** · Reasonable accommodations may be made to enable ...
-
Quality Assurance Specialist
1 week ago
JCR Industries LLC La Habra, United StatesJob Overview: · We are seeking a skilled and detail-oriented Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a crucial role in ensuring the quality and compliance of our products. Your main responsibilities will include conducting q ...
-
Quality Assurance Manager
1 week ago
Disney Anaheim, United StatesQuality Assurance Manager · **Job ID** · **Location** · - Anaheim, California, United States · **Business** · Disney Vacation Club · **Date posted** · May 09, 2024 · **Job Summary**: · The Quality Assurance Manager role manages the entire contract process at Disney Vacation Club ...
-
Quality Assurance Manager
1 week ago
Disney Vacation Club Anaheim, United StatesThe Quality Assurance Manager role manages the entire contract process at Disney Vacation Club (DVC). The Quality Assurance Manager is an individual contributor role that will work as part of a small team dedicated to accuracy of sales, legal compliance, member understanding and ...
-
Quality Assurance Manager
1 week ago
Aries Beef Burbank, United StatesThis role will support the QA processes which may include day to day food safety and quality assurance functions along with raw materials, ingredients management and reviewing supporting documents as they pertain to preshipment. This role will be responsible for product release, ...
-
Quality Assurance Manager
1 week ago
Caldera Medical Westlake Village, United States**Quality Assurance Manager** · **Located in Westlake Village, CA; Onsite - No remote option.** · **Caldera Medical's Mission - To Improve the Quality of Life for Women** · Caldera Medical is a growth stage medical device company dedicated to improving the quality of life for wom ...
-
Quality Assurance Associate
18 hours ago
Northstar Chemical Santa Fe Springs, United States**About us** · Northstar Chemical is a well-respected company in the chemical industry based in Sherwood, OR with locations in Tacoma, WA; Modesto, CA; and Los Angeles, CA. We specialize in mini-bulk and bulk deliveries of commodity chemicals to municipal and industrial customers ...
-
Quality Assurance Supervisor
6 days ago
Omni Therapy Fullerton, United States**Company Description** · Omni Therapy is a home health company who partners with home health and hospice agencies to facilitate physical therapy, occupational therapy, speech therapy, and nursing visits to patients in the comfort of their own home. · **Qualifications**: · - 2+ y ...
-
Quality Assurance Manager
1 day ago
Actalent Agoura Hills, United States Full time**Exciting opportunity to manage Quality team for rapidly growing company** · Description: · Manage the Quality Affairs team · Develop/improve/maintain processes and procedures to ensure the most robust product designs and product quality is consistently manufactured. · Ensure ti ...
Senior Specialist, Clinical Quality Assurance - El Segundo, United States - ImmunityBio, Inc.
Description
ImmunityBio, Inc. is a late-stage immunotherapy company developing a broad pipeline of next-generation therapies that drive immunogenic mechanisms for defeating cancer and infectious disease. The company's immunotherapy platform is designed to activate both the innate (natural killer cell and macrophage) and adaptive (T cell) immune systems to create long-term "immunological memory." The U.S. Food and Drug Administration (FDA) has accepted for review ImmunityBio's resubmission of its Biologics License Application (BLA) for N-803, a first-in-class IL-15 superagonist, plus Bacillus Calmette-Guérin (BCG) for the treatment of BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ (CIS) with or without Ta or T1 disease, and has set a user fee goal date (PDUFA date) of April 23, 2024.
Why ImmunityBio?
• ImmunityBio is developing cutting edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.
• Opportunity to join an early-stage public biopharmaceutical company with a headquarters in Southern California.
• Work with a collaborative team with the ability to work across different areas at the company.
• Ability to join a growing company with development opportunities.
Position Summary
The Senior Specialist, Clinical Quality ensures GCP compliance with ImmunityBio entity standard operating procedures, ICH and US FDA regulations and guidelines, and clinical study protocols. This position interacts cross-functionally with functional teams in Clinical Trials which include Clinical Operations, Regulatory, Pharmacovigilance, Medical Writing and Data Management to ensure compliance to the GCP Quality Management System and all applicable regulatory requirements. This role is responsible for maintaining inspection readiness at all times.
Essential Functions
$120,000 (entry-level qualifications) to $150,000 (highly experienced
The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.
ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options
• Health and Financial Wellness Programs
• Employer Assistance Program (EAP)
• Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability
• Healthcare and Dependent Care Flexible Spending Accounts
• 401(k) Retirement Plan with Company Match
• 529 Education Savings Program
• Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
• Paid Time Off (PTO) includes: 11 Holidays
• Exempt Employees are eligible for Unlimited PTO
• Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day
• We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.
At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.
ImmunityBio is a mandatory vaccination employer for COVID-19 and its variants. The Company requires that its employees be fully vaccinated as of their start date. If you require a medical or religious accommodation we will engage in the interactive process with you. Proof of vaccination will be required prior to start. If we make you an offer and you are not yet vaccinated, we will accommodate a delay in start date. ImmunityBio may also mandate that its employees receive vaccine boosters, and all accommodation laws will be followed.
