QA SpecialistBioPhase Solutions • Orange County, CA, US
QA Specialist
BioPhase Solutions • Orange County, CA, US
30+ days ago
Job type
- Full-time
Job description
Job Description
Job Description
BioPhase Solutions specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for a QA Specialist to work for an Orange County area contract manufacturing company.
Pay Rate: $25-35/hour depending on experience.
Summary:
Review GMP technical documentation to ensure quality standards are met and compliant with applicable SOPs, US FDA 21CFR210, 211, 11 and applicable ICH guidance documents. Develop and revise QA procedures to strengthen cGMP compliance.
Responsibilities:
- Performing timely review of batch records, test results and supporting technical documentation. Work closely with QA management to proactively address the quality of documentation.
- Collaborating effectively with operations management to review and approve: SOPs, protocols, reports, equipment qualifications and calibrations, change controls, specifications, and other quality, documentation.
- Providing assistance during cGMP compliance inspections of the facility by clients, the FDA and/or other regulatory bodies. This includes coordinating the retrieval of quality documents/records/trend data and any other documentation requested during these inspections.
- Providing support for execution of the supplier assurance program at the site
- Supporting review and release of raw materials and final product.
- Providing cGMP compliance guidance and advice as needed.
- Reviewing and approve deviations.
- Supporting QA management in gathering data necessary for tracking quality metrics.
- Maintaining workspace cleanliness by adhering to the 5S method of organization.
- Abiding by safe work practices and adhere to general safety rules, performing all duties in a safe manner and never placing yourself or those around you in an unsafe condition. Report all unsafe conditions to your supervisor.
- This list of duties and responsibilities is not all inclusive and may be expanded to include other duties and responsibilities, as management may deem necessary.
Qualifications:
- Preferred 2 – 3 years industry related work experience.
- Bachelor's degree or equivalent in scientific discipline required.
- Proficient experience and knowledge of cGMP regulations, and FDA and ICH guidelines as they pertain to contract laboratory and/or aseptic manufacturing operations.
- Proficient experience and knowledge of USP, Pharm. Eur. (EudraLex) and other applicable standards.
- Proficient knowledge of root cause investigation and problem solving; experience in the use of 5 Whys and/or other appropriate root cause investigation tools.
- Proficient experience and knowledge in the use of LIMS and electronic documentation systems (i.e. MasterControl).
- Works on problems of diverse scope; exercises good judgement in selecting methods and techniques for obtaining solutions while handling Quality Assurance tasks.
- Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Project, etc.).
Please send resumes to mia@biophaseinc.com and visit our website at www.biophaseinc.com for additional job opportunities!!!
Create a job alert for this search
QA Specialist • Orange County, CA, US
Similar jobs
SGS is the global leader and innovator in inspection, verification, testing and certification services.Founded in 1878, SGS is recognized as the global benchmark in quality and integrity.With over ...Show more
Pay Rate Low: 21 | Pay Rate High: 23.Our client, a growing food and snack manufacturer, is looking for a skilled QA Lead to join their team in Chino, CA!.The QA Lead is responsible for supporting a...Show more
AHEAD builds platforms for digital business.By weaving together advances in cloud infrastructure, automation and analytics, and software delivery, we help enterprises deliver on the promise of digi...Show more
Software, Firmware and QA Project Manager We are seeking a Software Project Manager to drive execution and delivery of software projects and hardware programs across semiconductor test ecosystems.T...Show more
You're an important part of our future.Hopefully, we're also a part of your future! At B.Braun, we protect and improve the health of people worldwide.You support this vision, bringing expertise and...Show more
Product Testers are wanted to work from home nationwide in the US to fulfill upcoming contracts with national and international companies.We guarantee 15-25 hours per week with an hourly pay of bet...Show more
L3Harris is dedicated to recruiting and developing high-performing talent who are passionate about what they do.Our employees are unified in a shared dedication to our customers' mission and quest ...Show more
Product Specialist US-CA-Irvine Job ID: 2025-15645 Type: Employee # of Openings: 1 Category: Marketing and Product Management US-CA-Irvine-2851 Overview Reporting to Senior Product Management Lead ...Show more
The Engineering Team at Russell Tobin & Associates.Apply today for early consideration.Day-to-Day Responsibilities/Workload:.Perform structural and line design analysis using PLS-CADD, PLS-Pole and...Show more
Qcells Service Solutions('QSS') is a residential solar asset operation and maintenance service company powered by Qcells.QSS set up a design standard and installation guide for EnFin TPO and provid...Show more
Quality Assurance & Quality Control Specialist.Company: Foods/Condiments Manufacturing.Work Hours: M-F 8:30-17:30 or 8:00-17:00.Work Style: On-site (no remote, no hybrid).Benefit: Health, Dental, V...Show more
Job title: Project Specialist 1.Job location: Pomona, CA 91768 - Hybrid 2 day(s) onsite.Job duration: 12+ Months Contract.Responsible for user liaison, system specifications, systems design, analys...Show more
Software, Firmware and QA Project Manager.We are seeking a Software Project Manager to drive execution and delivery of software projects and hardware programs across semiconductor test ecosystems.T...Show more
The salary range for this position is $55,000--$194,800.Salary will be commensurate with experience.The posted UC salary scales set the minimum pay determined by rank and step at appointment.See Ta...Show more
Braun US Pharmaceutical Manufacturing LLC.Irvine, California, United States.Wednesday, Tuesday, Thursday, Friday, Monday.Other key product areas include nutrition, pharmacy admixture and compoundin...Show more
L3Harris is dedicated to recruiting and developing high-performing talent who are passionate about what they do.Our employees are unified in a shared dedication to our customers' mission and quest ...Show more
AlliedTravelCareers is working with Prime Time Healthcare to find a qualified Cath Lab Tech in Chino, California, 91708!.Now Hiring: Allied Healthcare Cath Lab - Chino, CA.Contact us for Pay Inform...Show more
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients worldwide.Job Title: Project Specialist 1.Job Type: Te...Show more
QA Engineer
SGS Australia • Irvine, CA, US
Full-time
Last updated: 19 days ago
QA Lead (2nd shift)
Astrix Inc • Pomona, CA, United States
Full-time
Last updated: 2 days ago • Promoted
Sr. Specialty Solutions Engineer - Observability
AHEAD USA • Irvine, CA, United States
Full-time
Last updated: 3 days ago • Promoted
Software, Firmware and QA Project Manager
Advantest America Corporation • Lake Forest, CA, United States
Full-time
Last updated: 2 days ago • Promoted
QA Engineer II
B Braun Medical • Irvine, California, United States
Full-time
Last updated: 24 days ago • Promoted
Work From Home - Product Specialist - $45 per hour
GL1 • Rancho Cucamonga, California
Remote
Part-time +1
Last updated: 30+ days ago • Promoted
Senior Specialist Quality Engineer
L3Harris Technologies • Yorba Linda, CA, United States
Full-time
Last updated: 3 days ago • Promoted
Product Specialist
ITT Cannon • Irvine, CA, United States
Full-time
Last updated: 2 days ago • Promoted
Senior Engineer V
Pride Global • Pomona, CA, United States
Full-time
Last updated: 3 days ago • Promoted
Senior Manager of QA/QC
Qcells • Irvine, CA, United States
Full-time
Last updated: 2 days ago • Promoted
QA QC Specialist
Pasona N A, Inc. • Irvine, CA, United States
Full-time
Last updated: 2 days ago • Promoted
Project Specialist 1
Pacer Staffing • Pomona, CA, United States
Temporary
Last updated: 3 days ago • Promoted
Software, Firmware and QA Project Manager
Advantest • Lake Forest, CA, United States
Full-time
Last updated: 2 days ago • Promoted
Specialist Position - Hochbaum Lab
University of California - Irvine • Irvine, California, United States
Full-time
Last updated: 24 days ago • Promoted
Quality Engineering Specialist
B. Braun US Pharmaceutical Manufacturing LLC • Irvine, California, United States, 92602
Full-time
Last updated: 4 days ago
Senior Specialist Quality Engineer
L3Harris • Yorba Linda, CA, United States
Full-time
Last updated: 3 days ago • Promoted
Travel Cath Lab Tech - $2,506 to $2,801 per week in Chino, CA
AlliedTravelCareers • Chino, CA, US
Full-time
Last updated: 15 days ago • Promoted
Project Specialist 1
Tekwissen • Pomona, CA, United States
Temporary
Last updated: 2 days ago • Promoted