QA SpecialistBioPhase Solutions • Orange County, CA, US
QA Specialist
BioPhase Solutions • Orange County, CA, US
[job_card.30_days_ago]
[job_preview.job_type]
- [job_card.full_time]
[job_card.job_description]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.).
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 :
Please send resumes to mia@biophaseinc.com and visit our website at www.biophaseinc.com for additional job opportunities!!!
[job_alerts.create_a_job]
Qa Specialist • Orange County, CA, US
[internal_linking.similar_jobs]
Eurofins Scientific is a network of independent companies providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, heal...[show_more]
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]
The Quality Control and Test Lab Associate is responsible for conducting quality control inspection and component testing required by the customer or per our standard procedure.Identifies product n...[show_more]
NURA is seeking a Quality Analyst to help our growing team.Primary responsibilities will be inspecting and testing raw materials to meet our quality standards to include maintaining our lab equipme...[show_more]
A company is looking for a Customer Support Specialist - MST (Weekends).Key Responsibilities Troubleshoot and respond to customer inquiries primarily through chat and calls Increase product and ...[show_more]
The salary range for this position is $93,200 - $194,800.The posted UC salary scales set the minimum pay determined by rank and step at appointment.
QNifxBxLzwVT3Icr63X2YxPZ3aA58AWX / view.Tuesday, Ja...[show_more]
Responsible for monitoring the pre-analytical, analytical and post analytical process of the clinical laboratory services and ensuring compliance with regulatory, state and accreditation requiremen...[show_more]
Volt is immediately hiring for .Automation Specialist 3rd shift .Food Manufacturing company in .Automation Specialist 3rd shift .
Maintains and provides troubleshooting of plant ...[show_more]
The Career Services, Quality Assurance Manager plays a pivotal role under the direct supervision of the Executive Director, Career Services, focusing chiefly on ensuring that employment verificatio...[show_more]
Represent the company in the procurement, negotiation, and administration of non-complex contracts for goods or services.
Ensure that contracts with customers are satisfactorily fulfilled and that f...[show_more]
Technical Oversight Specialist (Building Products).Rancho Cucamonga, California / Medley, Florida / Tulsa, OK.Founded in 1995 by a group of experienced certification and testing experts, QAI is an in...[show_more]
As a Public-Private Solutions (PPS) Product Specialist Senior, your primary responsibility will be to manage the PPS Product Lifecyle from development to successful growth and ongoing management.As...[show_more]
Job Title : Key Account Quality Control Specialist.Oversee quality assurance processes for key accounts, ensuring all service standards are met.
Develop and implement quality assurance policies and p...[show_more]
Certified Home Health Aide (CHHA).You will directly work with patients, following a one-on-one care plan in patient homes.
You operate with a big heart, not only providing personalized and attentive...[show_more]
We are seeking a detail-oriented Regulatory Compliance Specialist to join our quality assurance team at an established food processing and distribution company.
This role will be instrumental in mai...[show_more]
HORIBA is a global group of companies that develops, manufactures, and provides an extensive array of analytical and measurement equipment to countries around the world.
HORIBA INSTRUMENTS INCORPORA...[show_more]
Arrow Route, Rancho Cucamonga, CA, 91730, US.Remote Work Schedule Availability?.This position entails access to export-controlled items and employment offers are conditioned upon an applicant's abi...[show_more]
We are looking for a proactive and technically sharp Tax Specialist to develop individual tax plans for clients as part of our strategic wealth planning services.
The successful candidate will posse...[show_more]
Quality Assurance Specialist - Eurofins Environment Testing, Calscience, Tustin, CA
Eurofins USA Environment Testing • Tustin, CA, US
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
QA Engineer
SGS Australia • Irvine, CA, US
[job_card.full_time]
[last_updated.last_updated_variable_days]
QC and Test Lab Associate - Netherlands
Rand Technology, LLC • Irvine, CA, US
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Quality Control Analyst
Nura • Irvine, CA, US
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Customer Support Specialist
VirtualVocations • Ontario, California, United States
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Specialist
University of California - Irvine • Irvine, CA, United States
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
QA Manager
Prelude Corporation • Laguna Hills, CA, US
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Automation Specialist 3rd shift
Volt • Rancho Cucamonga, CA, US
[job_card.full_time]
[last_updated.last_updated_variable_hours] • [promoted] • [new]
Career Services, Quality Assurance Manager
West Coast University • Irvine, CA, US
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Contracts Administrator Specialist
804 Technology • Irvine, CA, US
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Technical Oversight Specialist
QAI Laboratories Inc • Rancho Cucamonga, CA, US
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Public-Private Solutions (PPS) Product Specialist Senior
Capital Group • Irvine, CA, United States
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Key Account Quality Control Specialist
SwiftX Inc. • Ontario, CA, US
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Certified Home Health Aide
MEDQUEST HEALTH SERVICES INC • San Clemente, CA, US
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Regulatory Compliance Specialist
Astrix • Pomona, CA, US
[job_card.full_time]
[last_updated.last_updated_variable_hours] • [promoted] • [new]
SAP CPQ Specialist
Horiba Instruments • Irvine, CA, US
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Quality Manager
Howmet • Rancho Cucamonga, CA, United States
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Tax Specialist
Tax Alchemy • Irvine, CA, US
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]