Quality assurance specialist jobs in Oceanside, CA - 353 jobs
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Quality Assurance Specialist
Quality Assurance Associate
Document Specialist
Quality Assurance Auditor
Quality Assurance Director
Quality Assurance Coordinator
Quality Assurance Administrator
Quality Assurance Lead
Director of Quality Assurance & Compliance
Cirsium Biosciences
Quality assurance specialist job in San Diego, CA
A biotechnology firm located in San Diego, California, is seeking a Director of Quality Assurance to lead the QA function. The role involves developing and implementing GxP quality systems, ensuring compliance with regulatory requirements, and driving continuous improvement. Candidates should have at least 7 years of experience in Quality Assurance within the pharmaceutical or biotech sectors and possess extensive knowledge of GxP regulations. This position offers competitive compensation and employee benefits in a collaborative environment.
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$131k-214k yearly est. 3d ago
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Director, GCP Quality Assurance - Lead Clinical Compliance
Crinetics Pharmaceuticals, Inc. 3.9
Quality assurance specialist job in San Diego, CA
A leading pharmaceutical company in San Diego seeks a Director, Quality Assurance (GCP) to oversee GCP QA systems, ensuring compliance with regulatory requirements. The role demands extensive experience in GCP as well as a strong leadership and auditing background. The ideal candidate will have a track record of developing quality strategies and collaborating across multiple teams. Competitive compensation includes a salary range of $176,000 - $220,000, alongside comprehensive health benefits and additional perks.
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$176k-220k yearly 3d ago
Quality Supply Assurance Specialist II
Hologic 4.4
Quality assurance specialist job in San Diego, CA
Are you driven by quality, detail, and making sure issues are resolved the right way the first time? Hologic is seeking a Quality Supply AssuranceSpecialist II to support our business operations by ensuring timely resolution of quality issues while maintaining full compliance for non-conformances and associated quality records. In this role, you'll work cross-functionally to support MRB and product quality forums, guide investigations, and contribute to continuous improvement across our Quality Management System. If you enjoy working in a highly detailed, regulated environment and want to help ensure safe, reliable products reach our customers, this role is for you.
Knowledge
Working knowledge of FDA Quality System Regulations and ISO 13485.
Familiarity with risk management concepts and quality workflows related to non-conformances, corrections, and corrective actions.
Understanding of Quality Systems elements such as Material Review Board (MRB), Product Quality Committee (PQC), and quality metrics.
Knowledge of ERP-based quality transactions and basic quality data reporting.
Skills
Ability to review and assess non-conformance, correction, and corrective action records for accuracy, completeness, and appropriateness.
Strong facilitation skills to support and coordinate cross-functional meetings (MRB, PQC, Product Response Team).
Proficiency in Microsoft Word, Excel (including graphing and data presentation), and related office tools.
Experience working in ERP systems (strongly preferred).
Excellent oral and written communication skills, including clear technical writing for quality records and SOP support.
Ability to support investigations using quality workflows, trend queries, and other analytical tools.
Strong organizational and multitasking skills in a detail-oriented, regulated environment.
Behaviors
Self-starter who works effectively with minimal supervision.
Detail-focused and diligent in maintaining compliant, accurate quality records.
Collaborative team member who enjoys partnering across departments and acting as a QA interface.
Continuous improvement mindset, actively contributing ideas to improve processes and quality system performance.
Accountable and reliable, ensuring timeliness in deliverables and follow-through on quality commitments.
Experience
BA/BS degree required, or equivalent experience/certification.
2+ years of experience in Quality, with strong emphasis on Quality Systems and non-conformances.
Experience in an FDA-regulated environment is required.
Experience supporting external audits and regulatory body inspections is beneficial.
ASQ Certification (CQA, CQE) preferred.
Why join Hologic?
We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.
The annualized base salary range for this role is $65,900- $103,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.
Agency and Third-Party Recruiter Notice
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
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$65.9k-103k yearly Auto-Apply 20d ago
GMP Auditor, QA Compliance
Artiva Biotherapeutics
Quality assurance specialist job in San Diego, CA
About Artiva:
Artiva is clinical-stage, publicly-traded biotechnology company focused on developing natural killer (NK) cell-based therapies for patients suffering from devastating autoimmune diseases and cancers. Artiva's lead program, AlloNK , is an allogeneic, off-the-shelf, non-genetically modified NK cell therapy candidate designed to enhance the antibody-dependent cellular cytotoxicity effect of monoclonal antibodies to drive B-cell depletion. AlloNK is delivered in the outpatient setting with no required hospitalization.
AlloNK is currently being evaluated in three ongoing clinical trials for the treatment of B-cell driven autoimmune diseases. This includes two company-sponsored trials, one in systemic lupus erythematosus for patients with or without lupus nephritis, and a basket trial across autoimmune diseases (Rheumatoid Arthritis, Systemic Sclerosis, Idiopathic Inflammatory Myopathies and Sjögren's Disease), as well as an investigator-initiated basket trial in B-cell driven autoimmune diseases. Artiva's pipeline also includes CAR-NK candidates targeting both solid and hematologic cancers.
Artiva was founded in 2019 as a spin out of GC Cell, formerly GC Lab Cell Corporation, a leading healthcare company in the Republic of Korea, pursuant to a strategic partnership granting Artiva exclusive worldwide rights (excluding Asia, Australia and New Zealand) to GC Cell's NK cell manufacturing technology and programs. Artiva is headquartered in San Diego, California.
For more information, visit ******************
Job Summary:
This position is responsible for cGMP auditing and supplier management activities at Artiva.
Duties/Responsibilities:
Perform GMP/GDP audits in accordance with the external and internal audit program.
Support GXP audits (GLP, GCP, GCLP), as necessary.
Perform Drop-In GMP Internal audits.
Create and maintain audit schedules.
Track audit responses to completion.
Oversee and maintain the supplier qualification program.
Support the creation and execution of Quality Agreements with suppliers.
Update databases, prepare metrics, identify and communicate trending and tracking of audits and related supplier management activities.
Support audits by regulatory or state agencies and partners.
Support QA review of Analytical Development and Process Development data and reports, as needed.
Follow applicable regulations, including FDA, ISO, ICH, company policies and procedures.
Support other QA department needs as identified by management.
Requirements:
Bachelor's degree or a combination of relevant education and applicable job experience
5+ years' experience in an FDA regulated industry and expert knowledge of CGMP regulations
Certified Quality Auditor credential is a plus.
Ability to adapt quickly to shifting needs and/or priorities
Able to interface well with all levels of personnel
Excellent communications skills, both written and verbal and a high degree of professionalism
Exceptional attention to detail
Flexibility to travel
Why you should apply:
We have a fantastic team and philosophy! We are passionate - We deeply care about our team, our science, and improving the lives of autoimmune and cancer patients. We are tenacious - we are laser-focused on our mission and undeterred in our commitment to make cell therapies broadly accessible to patients with autoimmune disease and cancer. We are innovative - pushing into new frontiers for patient benefit. We are transparent - believers in flat, accessible, and open communication paths. We are inclusive - committed to the diversity of our team and ensuring that all voices are heard.
In addition to a great culture, we offer:
· A beautiful facility
· An entrepreneurial, highly collaborative, and innovative environment
· Comprehensive benefits, including:
Medical, Dental, and Vision
Group Life Insurance
Long Term Disability (LTD)
401(k) Retirement Plan with match
Employee Assistance Program (EAP)
Flexible Spending Account (FSA)
Paid Time Off (PTO)
Company paid holidays, including the year-end holiday week
Our recognition program, Bonus.ly, is where you can trade in points earned for things you want.
If all this speaks to you, come join us on our journey!
Base Salary: $100,000 - 120,000. Exact compensation may vary based on skills and experience.
$100k-120k yearly 60d+ ago
EHS/QA Admin
Protec Arisawa America, Inc.
Quality assurance specialist job in Vista, CA
:
Protec Arisawa is the global leader in the design and manufacturing of FRP (Fiber Reinforced Plastic) Pressure Vessels for membrane filtration systems. With over 40 years of experience in filament winding, Protec Arisawa is known for high-quality pressure vessels with leading technology. We have three production sites located on three different continents, ensuring a global presence, and providing our customers with reliable solutions.
Job Description :
The Environment, Health, Safety and Quality Assurance Admin will be responsible for overseeing day-to-day operations related to health, safety and quality at Protec Arisawa. This includes conducting risk assessments, developing safety procedures, implementing training programs, investigating accidents, and ensuring compliance with all applicable health, safety and quality regulations.
Primarily Duties & Responsibilities:
I. EHS
Practice safe working techniques and enforce the EHS policies, guidelines and procedures as set out by the Company.
Perform inspections and evaluations to identify potential hazards, and ensure compliance with all applicable Company, City, State, Federal, and CAL/OSHA requirements.
Manages the inspection of and supply of PPE and other safety related equipment.
Performs initial and refresher training for programs to ensure compliance.
Coordinates training with third parties as needed for additional training e.g., Fire extinguisher, forklift, CPR, Medical, etc.
Tracks and manages training conducted for record keeping with HR personnel files.
Manages training and compliance for HAZMAT/WASTE.
Completes annual web-based reporting for OSHA/RCRA/CERS.
Assist HR in the investigation of accidents, injuries, near misses and/or situations of non-adherence to policies and complete the appropriate 300, 300A, 301 reports as needed.
Assist with the follow up after an accident, incident or near miss situation to ensure the appropriate corrective actions have been implemented to prevent recurrence.
Perform administrative duties related to department records and files.
Assist with the approval of Safety supplies and equipment for the company.
Perform other administrative duties such as typing letters/memos, faxing, copying, and distributing items as needed.
Attain knowledge to proficiently manage the following programs: Bloodborne pathogen, CPR/Medical, Crane safety, Electrical safety, LOTO, Emergency Action plan, Fire Safety, HAZMAT/HAZCOM, Fall protection, Hearing Conservation, Respirator, Machine Guarding, PPE, Forklift, Ladder, Spill Response, Heat Stress, Equipment Safety.
Performs other duties as assigned and as necessary.
II. QA
Support QA Dept. and comply with the company's Quality Management System policies and procedures.
Maintain and improve processes to monitor document workflow performance, compliance, and reliability.
Assist QA Dept in the generation of Quality reports.
Assist QA Dept with Plant inspections on equipment and product.
Performs other duties as assigned and as necessary.
Secondarily Duties & Responsibilities:
Provide general administrative assistance to department managers.
Support special projects as assigned.
Performs other duties as assigned and as necessary.
Required Qualifications
High school diploma or equivalent; associate degree preferred.
Min. 3 years of administrative or office support experience.
Strong written and verbal communication skills.
Proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint).
Excellent organizational skills and attention to detail.
Ability to multitask and prioritize in a fast‑paced environment.
Familiarity with office equipment and modern collaboration tools (Teams, Zoom, SharePoint).
Key Competencies
Professionalism and confidentiality
Customer service mindset
Problem‑solving and critical thinking
Initiative and adaptability
Team collaboration
$43k-70k yearly est. Auto-Apply 11d ago
Quality Assurance Coordinator
Connexion Systems + Engineering
Quality assurance specialist job in San Diego, CA
Connexion's mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve. Title: Quality Assurance Coordinator
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
Duration: 5+ month contract, potential for extension or conversion
Pay rate: $35-$37.10/hr
Job Location: San Diego, CA
Schedule: Mon - Fri, 1
st
shift
Job#: bh18414
Description:
We're supporting a fast-growing life sciences organization in identifying an experienced Quality Assurance Coordinator to join their Quality team. This is an excellent opportunity for someone looking to deepen their experience in regulated environments, contribute to a robust Quality Management System, and support an upcoming ERP system rollout. About the Role
The QA Coordinator will play a key role in supporting Quality Assurance activities, document control, and QMS compliance within a dynamic and collaborative environment. This individual will contribute to the implementation, maintenance, and continual improvement of the organization's Quality Management System (QMS) and will be involved in cross-functional interactions across Manufacturing, R&D, Supply Chain, IT, and more. Key Responsibilities
Process and manage document control requests; support training activities within the eQMS (SmartSolve).
Assist with QA tasks related to the company's new ERP system implementation.
Collaborate across multiple quality processes, including change control, nonconformance, complaints, CAPA, supplier quality, audits, risk management, product release, and design control.
Ensure compliance with quality procedures and maintain complete, accurate quality records.
Generate, review, and maintain QMS documentation.
Track and report QMS performance metrics, KPIs, and data for monthly and management reviews.
Support preparation and execution of internal audits and external regulatory/customer audits.
Participate in QMS system enhancements and expanded use of eQMS features.
Coordinate daily tasks, training plans, and overall workflow to ensure timely completion.
Provide cross-functional support and serve as a resource on critical QMS processes.
Perform additional QA-related tasks or special projects as needed.
Required Skills & Qualifications
Understanding of quality standards and regulations such as ISO 13485, MDSAP, FDA 21 CFR 820, and EU IVDD.
Proficiency with MS Office tools (Word, Excel, PowerPoint) and Adobe Acrobat.
Strong organizational skills, attention to detail, and ability to manage multiple priorities.
Strong communication and interpersonal skills.
Ability to work independently with minimal supervision.
Quick learner with solid problem-solving abilities.
Education & Experience
Bachelor's degree in a scientific discipline or equivalent experience.
At least 1 year of Quality Assurance experience in a regulated environment (GMP/GLP preferred).
Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you shortly.
You may also send your resume and cover letter via email to the recruiter listed below. You MUST include the Job# and Job Title in your subject line.
If you are active in a job search but this job is not for you, please reach out to *************************. We would be glad to help you find the perfect job
$35-37.1 hourly Easy Apply 53d ago
Assurance Experienced Associate
BDO USA 4.8
Quality assurance specialist job in San Diego, CA
The Assurance Experienced Associate will be responsible for preparing financial statements with disclosures, applying basic areas of GAAP as necessary and documenting, validating, testing, and assessing various control systems. This position may also be involved in reviews and agreed-upon procedure engagements.
Job Duties:
Control Environment:
Applies knowledge and understanding of the collective effect of various factors on establishing or enhancing effectiveness, or mitigating the risks, of specific policies and procedures by:
Identifying and considering all applicable policies, laws, rules, and regulations of the firm, regulators, or other authoritative bodies as part of engagement team
Making constructive suggestions to improve client internal controls and accounting procedures
Documenting and validating the operating effectiveness of the clients' internal control system
GAAP:
Applies knowledge and understanding of governing principles; applying these principles to client transactions; and documenting and communicating an understanding and application of these principles by:
Providing support of conclusions with authoritative literature
Drafting basic sets of financial statements with disclosures
Researching intermediate areas of accounting and forming an initial opinion on the correct treatment independently
GAAS:
Applies knowledge and understanding of professional standards; application of the principles contained in professional standards; and the ability to document and communicate an understanding and application of professional standards on an engagement by:
Developing and applying an intermediate knowledge of auditing theory, a sense of audit skepticism, and the use of BDO audit manuals
Applying auditing theory to various client situations
Documenting in line with BDO policy, identifying deviations and notifying more senior team members in order to obtain appropriate approvals
Applying knowledge to identify instances where testing may be reduced or expanded and notifying more senior team members of the occurrence
Contributing ideas/opinions to the engagement teams
Methodology:
Applies knowledge and application of BDO standards to guide effective and efficient delivery of quality services and products by:
Completing all appropriate documentation of BDO work papers
Ensuring assigned work is performed in accordance with BDO methodology and requirements
Research:
Applies methodology used to seek or maintain information from authoritative sources and to draw conclusions regarding a target issue based on the information by:
Researching basic and intermediate accounting topics and forming an initial opinion on the treatment independently
Other duties as required:
Supervisory Responsibilities:
N/A
Qualifications, Knowledge, Skills and Abilities:
Education:
Bachelor's degree in Accounting, Finance, Economics or Statistics, required OR Bachelor's degree in other focus area and CPA certification, required
Master's in Accountancy, preferred
Experience:
One (1) or more years of prior relevant audit experience and/or public accounting, private industry accounting or consulting/professional services experience, required
License/Certifications:
Eligible to sit for the CPA exams upon starting employment required and actively pursuing completion of the exams, required
CPA, preferred
Software:
Proficient with the Microsoft Office Suite, preferred
Experience with assurance applications and research tools, preferred
Language:
N/A
Other Knowledge, Skills & Abilities:
Basic understanding and experience planning and coordinating the stages to perform an audit of a basic public and/or private company
Ability and willingness to travel, as needed
Knowledge of internal accounting controls and professional standards and regulations (GAAP, GAAS, Sarbanes-Oxley, etc)
Strong verbal and written communication skills with the ability to adapt style and messaging to effectively communicate with professionals at all levels both within the client organization and the firm
Ability to successfully multi-task while working independently and within a group environment
Solid analytical and diagnostic skills and ability to break down complex issues and implementing appropriate resolutions
Ability to of work in a demanding, deadline driven environment with a focus on details and accuracy
Solid project management skills
Individual salaries that are offered to a candidate are determined after consideration of numerous factors including but not limited to the candidate's qualifications, experience, skills, and geography.
California Range: $83,000 - $90,000
Colorado Range: $75,000 - $80,000
Illinois Range: $76,000 - $82,000
Maryland Range: $72,000 - $78,000
Minnesota Range: $70,000 - $74,000
NYC/Long Island/Westchester Range: $75,000 - $80,000
New Jersey Range: $76,500 - $83,000
Ohio Range: $70,000 - $78,000
Washington Range: $80,000 - $85,000
$83k-90k yearly Auto-Apply 4d ago
Production Documentation Specialist
Stefanini_Training 4.6
Quality assurance specialist job in Irvine, CA
Stefanini Group is looking for Production Documentation Specialist - Irvine, CA This position is responsible for the generation/issuance of master batch record documentation, fulfillment of internal/external requests and housekeeping of active/archived department documents to support internal and external business requirements. · Generate, verify accuracy and issue master batch record documents including generation of LIMs record for drug product manufacturing and packaging based on the weekly production schedule, ensuring that all documentation required for each drug product batch is compiled prior to issuance to production for execution. · Daily monitor and update QA-issued SOP Binders used throughout the manufacturing site when new effective SOPs are issued, and perform routine audits of all TPM SOP Binders throughout the site. · Provide timely support and complete responses to QA documentation requests such as logbook issuance and reconciliation. · Maintain document master batch record files and QA archives, so they are appropriately filed, labeled, stored and readily accessible. · Maintain/update databases to ensure proper tracking of batch record issuance · Perform other duties as assigned, or as business needs require. Primary Outcomes · Completes accurate and timely review of all documentation listed above and ensures all Documentation is current, accurate and on schedule. · Works on assignments that are complex in nature, where ability to recognize deviation from accepted practice is required · Normally receives minimal instructions on routine work, and minimal instructions on new assignments Position Requirements: · Education Required: High School Diploma / GED · Education Preferred: AA Degree or some college · Experience Required: 3 years related experience · Experience Preferred: 4-6 years related experience · Specialized or Technical Knowledge Licenses, Certifications needed: N/A · Competencies: Please list five or six areas of competencies below that are necessary for the incumbent to do this position and that distinguish it from others similar to it
Technical · Strong computer literate and experience using "Windows" computer software applications such as Word and Excel. Excellent oral and written communication. Ability to proofread · Experience with Business Applications such as Oracle, Electronic Document Management System, and LIMs is strongly preferred. · Experience with Scientific and/or Pharmaceutical terms is required. Planning & Organizational · Strong organization and time management is required · Able to work with the production schedule and plan accordingly as documentation is issued 10 business days in advance of scheduled run. · Able to adapt to changes in schedule and respond accordingly in order to issue current, effective documentation. · Ability to work in environment with interruptions/urgent requests and resume previous activities seamlessly. · Overtime/Off Shift On-site support may be required. · Interpersonal Excellent interpersonal skills are required as this position requires daily contact with our internal customers. Teamwork is essential as coordination between Documentation Control personnel is mandatory. Communication Proficient verbal communication skills are required as this position requires contact with our internal customers. Autonomy and Independence Preferred.
$65k-106k yearly est. 60d+ ago
Information Assurance Admin III
General Atomics and Affiliated Companies
Quality assurance specialist job in San Diego, CA
General Atomics (GA), and its affiliated companies, is one of the world's leading resources for high-technology systems development ranging from the nuclear fuel cycle to remotely piloted aircraft, airborne sensors, and advanced electric, electronic, wireless and laser technologies.
We have an exciting opportunity for an ISSO to join our Security Classified Systems team. This position is located in San Diego (Rancho Bernardo) CA.
DUTIES AND RESPONSIBILITIES:
Interprets regulations as they apply to information systems, platforms, and IT operating processes, practices, and procedures.
Participates in the development or modification of the computer environment information assurance security program plans and requirements.
Participates in the development, distribution, and maintenance of System Security Plans, instructions, guidance, and standard operating procedures.
Participates in audits of IT, platforms, and operating procedures; analyzes results.
Participates in identifying risks and makes recommendations for improvements; may participate in corrective measures when incidents or vulnerabilities are discovered.
Maintains knowledge of applicable policies, regulations, and compliance documents related to classified computing assets and environments.
May represent the organization as a primary contact with internal representatives.
Maintains the strict confidentiality of sensitive information.
Performs other duties as assigned.
Responsible for observing all laws, regulations, and other applicable obligations wherever and whenever business is conducted on behalf of the Company.
Expected to work in a safe manner in accordance with established operating procedures and practices.
We recognize and appreciate the value and contributions of individuals with diverse backgrounds and experiences and welcome all qualified individuals to apply.
Typically requires a bachelors degree in a related discipline and six or more years of progressive professional experience in information assurance or a related field. Equivalent professional experience may be substituted in lieu of education
Must possess an active Secret clearance and have the ability to obtain and maintain a TS (with SAP & SCI eligibility)
Must be able to meet the requirements to obtain and maintain a Department of Energy (DOE) Q clearance
Must maintain DoD 8570 IAM Level I (e.g. Security +) professional certification as required by customers or contractual obligations.
Security + certification required.
Experience with DoD policy such as Risk Management Framework and Joint SAP Implementation Guide.
Operational experience with installing, troubleshooting, and auditing Windows desktop & server operating systems.
Experience with DISA STIGs, SCAP tool, ACAS.
Experience installing and troubleshooting common x86-based computer hardware.
Must demonstrate a general understanding of information assurance principles, theories, concepts and techniques. Must have experience organizing, planning, scheduling, conducting, and coordinating work assignments to meet project milestones or established completion dates.
Must possess the ability to understand new concepts quickly and apply them in an evolving environment while contributing to the development of new processes.
Must be customer focus and possess:
The ability to identify issues, analyze data and develop solutions to a variety of problems.
Good analytical, verbal and written communication skills to accurately document, report, and present findings.
Good interpersonal skills enabling an effective interface with other professionals; and good computer skills.
Ability to work independently or in a team environment is essential as is the ability to work extended hours as required.
$43k-70k yearly est. 51d ago
QA Associate
Actalent
Quality assurance specialist job in Carlsbad, CA
Are you looking to be part of a dynamic team in the cutting-edge world of additive manufacturing? Do you thrive in a fast-paced, growing environment that blends high technology and USA manufacturing? If so, we have the perfect opportunity for you! As a Quality Assurance Associate, you will play a crucial role in ensuring the highest standards of quality for our 3D printed products and services. Your focus will be on supporting and organizing critical Master Batch Records (MBRs) and Certificates of Conformances while supporting quality control activities such as data entries, lean manufacturing, record archiving, documenting training records, and supporting change controls.
Responsibilities
* Consistently apply core values of Integrity, Impact, and Dedication to your decision-making process and interactions with others.
* Uphold and contribute to the company's quality policy commitment.
* Prepare master batch record job folders for new production builds.
* Support and organize records and data entries to allow for timely approvals with accurate compilation of product Master Batch Records, including Certificates of Conformance.
* Verify manufacturing scheduling to ensure all quality activities occur at or ahead of schedule.
* Document and record data entries using ERP System, Excel, and JobBoss2 in cooperation with handwritten records.
* Review executed records for compliance, ensuring the completeness of all necessary testing and documents across various processes.
* Archive, scan, file, and sort physical and electronic records per quality standards.
* Ensure product processes adhere to established quality standards and guidelines.
* Support data collection and monitor data throughout the production process.
* Collaborate to identify and document defects, nonconformances, or deviations from quality standards.
* Work with quality leadership and production teams to resolve quality issues promptly.
* Support corrective actions to prevent recurrence of defects.
* Stay updated on industry trends, quality standards, and regulations.
* Support the maintenance of training records and training matrices.
* Assist with front office receiving and outgoing shipments for products and supplies.
* Develop and perform quality checks and documentation for incoming materials.
* Effectively communicate quality-related information to supervisors, colleagues, and stakeholders.
* Comply with ISO Quality Management System, FDA 21 CFR Part 820 Quality System Requirements, and medical device industry requirements.
* Assist in the implementation of the quality management system.
Essential Skills
* Understanding of quality assurance, GMP, GDP, and quality control principles.
* Strong understanding of GMPs and GDP for production and generation of batch records.
* Basic familiarity with mechanical testing and materials characterization.
* Excellent organizational skills.
* Ability to read and interpret engineering drawings and specifications.
* Problem-solving and troubleshooting skills.
* Organizational and time management skills.
* Strong attention to detail.
* Commitment to safety and quality assurance.
* Effective communication and interpersonal skills for cross-functional teamwork.
Additional Skills & Qualifications
* Hands-on experience with batch record review and Good Documentation Practices.
* Experience in quality control in the medical device, aerospace, or automotive industry.
* Experience with mechanical testing and materials characterization.
* Associate degree in a related field and/or 18 months-4 years of experience preferred.
Job Type & Location
This is a Contract to Hire position based out of Carlsbad, CA.
Pay and Benefits
The pay range for this position is $25.00 - $30.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Carlsbad,CA.
Application Deadline
This position is anticipated to close on Feb 5, 2026.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
$25-30 hourly 9d ago
Quality Assurance Associate
Spitrex-3D
Quality assurance specialist job in Carlsbad, CA
Job DescriptionSalary: $25 - $30/hr
Ready to Transform Your Career? Join SpiTrex 3D!
Are you looking to be part of a dynamic team in the cutting-edge world of additive manufacturing? Do you thrive in a fast-paced, growing environment that blends high technology and USA manufacturing? If so, we have the perfect opportunity for you!
We are a leading additive manufacturing company located in vibrant Carlsbad, California. Our innovative solutions are revolutionizing the industry, and we're seeking a talented Quality Assurance Associate to join our growing team. Imagine a workplace where your growth knows no bounds - where data drives success, and your career flourishes. We believe SpiTrex 3D is a workplace like no other. It is a place to be challenged, explore your curiosity, and grow your career.
Job Overview:
As a Quality Assurance Associate at SpiTrex 3D, you will play a crucial role in ensuring the highest standards of quality for our 3D printed products and services. Your focus will be on supporting and organizing critical Master Batch Records (MBRs) and Certificates of Conformances while supporting quality control activities such as with data entries (ERP System), lean manufacturing/scheduling, record archiving, documenting training records, and supporting change controls.
Essential Functions:
Company Culture and Mission:
Consistently apply core values (Integrity, Impact, Dedication) to your decision-making process and interactions with others.
Uphold and contribute to the companys quality policy commitment.
Master Batch Records:
Prepare master batch record job folders for new production builds
Support and organize records and data entries to allow for approvals in a timely manner with an accurate compilation of product Master Batch Records, which include Certificates of Conformance.
Assist in verifying manufacturing scheduling to ensure that all quality activities are occurring at or ahead of schedule.
Using Microsoft Word, Excel, and JobBoss2 document and record data entries in cooperation with handwritten records.
Review executed records for compliance, ensuring completeness of all necessary testing and documents across various processes as needed
Quality Control Records:
Archive, physical retains, printed records, and electronic records with scanning, filing, and sorting per quality standards.
Ensure product processes adhere to established quality standards and guidelines.
Support data collection and monitor data throughout the production process where needed.
Defect Detection/nonconformances:
Collaborate and support the identify and document defects, nonconformances, or deviations from quality standards.
Work closely with quality leadership and production teams to address and resolve quality issues promptly.
Support corrective actions to prevent recurrence of defects as needed.
Training and Education:
Stay updated on industry trends, quality standards, and regulations as needed.
Support the maintenance of training records and training matrixes.
Shipping Receiving:
Assist with front office incoming receiving and outgoing shipments for both products and supplies.
Assist in developing and performing quality checks and documentation for incoming materials.
Communication
Effectively communicate quality related information to supervisors, colleagues, and other relevant stakeholders.
Compliance
Comply with ISO 13485 Quality Management System, FDA 21 CFR Part 820 Quality System Requirements (QSR), and medical device industry requirements.
Assist in the implementation of the quantity management system.
Other work-related tasks as assigned.
Competency:
Understanding of quality control principles and inspection techniques.
Strong understanding of GMPs and GDP for production and generation of batch records.
Basic familiarity with mechanical testing and materials characterization.
Excellent organizational skills.
Basic ability to read and interpret engineering drawings and specifications.
Problem-solving and troubleshooting skills.
Organizational and time management skills.
Very strong attention to detail.
Strong commitment to safety and quality assurance.
Effective communication and interpersonal skills to work with cross-functional teams.
Education and Experience:
Associate degree in related field and/or 18 months-4 years experience preferred.
Experience in quality control in the medical device industry, aerospace, or automotive industry preferred.
Experience with mechanical testing and materials characterization preferred.
Benefits Include:
Medical, Vision and Dental Insurance
Short Term Disability
401(k) plus match
Vacation days
Paid holidays
$25-30 hourly 25d ago
Quality Assurance Coordinator
Usha Dharmacon
Quality assurance specialist job in San Diego, CA
Job TitleQuality Assurance Coordinator
About Us
Revvity is a developer and provider of end-to-end solutions designed to help scientists, researchers, and clinicians solve the world's greatest health challenges. We pair the enthusiasm of an industry disruptor with the experience of a longtime leader. Our team of 11,000+ colleagues from around the globe are vital to our success and the reason we're able to push boundaries in pursuit of better human health.
Find your future at Revvity
Overview:
BioLegend (a division of Revvity, Inc.) is seeking a highly motivated Quality Assurance Coordinator. The Quality Assurance Coordinator will be a multi-faceted and integral part of the Quality Assurance team and will perform and administer Quality Assurance (QA) activities at BioLegend, in accordance with BioLegend Vision, Mission, Quality Policy and Quality Objectives for implementation, maintenance and improvement of BioLegend's Quality Management System (QMS) and support the upcoming ERP system deployment. The QA Coordinator will be responsible for processing document control requests as well as assisting with the ongoing ERP project as needed, while supporting document control duties and training processes within current eQMS system (Smartsolve) as needed. Responsible for working with one or more of the following quality system processes: document control and training. Interacting with other QA departments and processes: change management, nonconformance, complaint management, CAPA management, supplier quality management, internal audits, post-market surveillance and vigilance management, risk management, QA product release and QA design control responsibilities. The QA Coordinator is responsible for ensuring quality systems procedures are followed and records are compliant in their applicable areas of responsibility. This role requires some work experience and knowledge of standards and regulations such as MDSAP, ISO 13485 and country and region-specific regulations (i.e. FDA 21 CFR 820, EU IVDD).
Qualified individuals must also be proficient in computer word processing using Word and in other data analysis and presentations programs such as Excel, and PowerPoint. The QA Coordinator should possess strong organization skills and attention to detail and accuracy and they must be self-motivated, able to multi-task, and work effectively in a fast-paced environment; Good communication and interpersonal skills are essential in interactions with employees and others. The QA Coordinator must be a fast learner with the ability to quickly analyze and solve problems.
Essential Functions
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Acts in a support capacity for critical QMS processes such as, non-conformances, complaint management, field corrective actions, risk management, design control, CAPA, document and change control, training, batch release, auditing, supplier Management and validation.
Reviews quality records for all related areas of responsibility.
Demonstrates the ability to work with limited direction and can prioritize projects independently
Responsible for personal daily task management, training plans and performance management.
Assist with generating, reviews and maintains QMS documents.
Assist with monitoring and trending QMS elements and providing metrics data for monthly reports, quality objectives and key performance indicators (KPIs).
Assists with data preparation for Quality Management Reviews.
Provides administrative support for external audits (regulatory or customer) and Internal Audits.
Participates in the use of the eQMS system and expanded applications as appropriate.
This position will interact with key internal stakeholders in Manufacturing, Facilities, IT, R&D, Customer Support and Supply Chain.
Assist with monthly and management review data and metrics for areas of responsibility.
Other projects or responsibilities as may be required.
Basic Qualifications:
Bachelors in a scientific discipline or equivalent work experience.
A minimum of 0-1 work experience in quality assurance. Experience with GMP/GLP or similar regulated products.
Experience in MS Word, Excel, Powerpoint, Adobe Acrobat (PDF)
OR
Associates Degree or equivalent work experience.
A minimum of 2 years' work experience in quality assurance. Experience with GMP/GLP or similar regulated products.
Experience in MS Word, Excel, Powerpoint, Adobe Acrobat (PDF)
Preferred Experience:
IVD, MDSAP, ISO 13485 or similar compliance experience
Work Environment & Physical Demands Office
While performing the duties of this job, the employee regularly works in an office setting. Occasional exposure to a laboratory and warehouse environment.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is regularly required to use hands and fingers to handle, feel, or operate objects, tools or controls, and reach with hands and arms. The employee is frequently required to stand, talk and hear.
The base salary range for this full-time position is $56,500.00 - $62,400.00. This range reflects the minimum and maximum target for a new hire in this position. The base pay actually offered to the successful candidate will take into account internal equity, work location, and additional factors, including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.
Please note that base pay is only one part of our total compensation package and is determined within a range. This range allows for the successful candidate to have an opportunity to progress within the position and develop at our company. This base pay range does not take into account bonuses, equity, or other benefits which may be applicable and are dependent on the level and position offered.
#LI-JB1
What do we offer?
We provide competitive and comprehensive benefits to our employees. Below are some highlights of our benefits:
Medical, Dental, and Vision Insurance Options
Life and Disability Insurance
Paid Time-Off
Parental Benefits
Compassionate Care Leave
401k with Company Match
Employee Stock Purchase Plan
Learn more about Revvity's benefits by visiting our Bswift page. Log-In instructions are provided towards the bottom of the Bswift page.
*For benefit-eligible roles only. Part-time and temporary roles may not be eligible for all benefits listed. Please reach out to your recruiter for more information.
Revvity is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to any characteristic or status protected by applicable federal, state, and/or local laws. If you are an applicant with a disability that requires reasonable accommodation to complete any part of the application process or are limited in the ability-or unable to use-the online application system and need an alternative method for applying, you may contact ********************.
$56.5k-62.4k yearly Auto-Apply 48d ago
Quality Assurance Associate III
Adarx Pharmaceuticals
Quality assurance specialist job in San Diego, CA
ADARx is seeking a qualified and highly motivated individual at the QA Associate III level to join the Quality Assurance (QA) group. This is a key role within the QA group and offers exciting opportunity for the successful candidate to make major contributions to the development, implementation and maintenance of the Quality Management System (QMS) at ADARx. This role will collaborate closely with CMC and Clinical functions at ADARx to ensure that quality practices, procedures, standards and systems are established and followed to maintain compliance to applicable cGxP regulations.
Essential Responsibilities:
* Assist in the development, implementation, improvement and maintenance of ADARx's overall Quality Management System (QMS).
* Support the implementation of an electronic Quality Management System (eQMS) and act as the administrator to ensure proper configuration and usage of the system. Provide training and support to eQMS users.
* Provide QA support and oversight to internal staff and suppliers to ensure compliance with SOPs and relevant cGxP requirements.
* Manage the Document Control process for creating or revising controlled documents following internal procedures.
* Manage the training program and ensure all GxP related personnel receive appropriate training. Maintain and update training files and training curricula.
* Support the development of QA-related training materials and provide QA process training to new and existing employees.
* Author, review, and approve Quality System records, including deviation, CAPA, change records, etc.
* Author, review, and approve controlled documents for QA and other functional areas.
* Conduct and support supplier qualification activities, including issuance and review of quality questionnaires, supplier audits, and review of quality agreements.
* Manage supplier files and the approved supplier list to ensure they are accurate and up-to-date.
* Support internal audits, including planning, risk assessment, scope, audit program development, fieldwork, reporting and action follow-up.
* Collect and summarize Key Quality Indicator (KQI) metrics for review to identify trends.
* Support the preparation and hosting of regulatory inspections and external audits.
* Proactively identify gaps/risks and propose solutions to support continuous improvement.
Essential Physical Characteristics:
Reasonable accommodation(s) may be made to enable qualified individuals with disabilities to perform the essential functions of a job, on a case-by-case basis.
On-Site Protocol:
Physical presence at the ADARx Pharmaceuticals worksite is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
Qualifications:
* BS/MS degree in a related scientific or technical discipline
* 6+ years of experience in the biotech/pharmaceutical industry
* 4+ years of experience in the QA function in a cGxP environment
* Strong understanding of cGMP and ICH regulations and guidance
* Demonstrated experience in development and implementation of quality processes, procedures and systems
* Prior experience using an eQMS is required
Preferred Qualifications
* Previous experience in a GMP QC lab or manufacturing environment preferred
* GCP experience a plus
* Experience in implementation and/or administration of an eQMS is a plus
Required Key Attributes:
* Must be able to work independently with supervision as needed.
* Must be collaborative, work well with other team members in a matrix team environment.
* Excellent written and verbal communication skills are essential for this role.
* Strong organizational skills with attention to detail and accuracy.
* Ability to maintain a high level of confidentiality and exercise discretion.
* Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges.
* Understand project timelines and deliverables and plans/coordinate project work accordingly with departmental, functional, and external stakeholders.
Compensation:
* This is a full-time position, Monday-Friday.
* Pay is commensurate with experience.
* Equity-based compensation
* Performance-based bonuses
* 401(k) with Company Match
* Medical, Dental, Vision
* Flexible Spending Account
* Life Insurance
* Employee Assistance Program
* Employee Discounts
* Gym Membership
* Paid Vacation
* Paid Holidays
* Paid Sick, Jury Duty, Bereavement
Work Authorization:
* United States (Required)
* Background Check
* As a condition of employment, you must successfully complete all post-offer, pre-employment requirements, including but not limited to a background check.
Company Overview:
ADARx Pharmaceuticals, Inc., (the "Company" or "ADARx") located in San Diego, is a late-clinical stage biotechnology company committed to turning cutting-edge science into life-saving therapeutics. ADARx has developed proprietary RNA targeting platforms and technology for silencing or editing target mRNA. ADARx has a growing pipeline of RNA targeting therapeutics for treating diseases across a range of therapeutic areas including genetic, cardiometabolic, complement-mediated diseases and central nervous system.
ADARx currently has multiple active programs in development with the lead candidate in the clinic. We are well-financed by a syndicate of highly regarded investors.
ADARx Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
Disclosure Statement
* The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
* Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
* The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual target bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, type and length of experience within the industry, and other job-related factors permitted by law.
* Total Compensation includes base salary; benefits: medical, vision, and dental insurance; life insurance; 401(k) matching program; paid time off; paid holidays; Employee Assistance Program; and other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including but not limited to cash bonuses.
* Following a conditional offer of employment, satisfactory completion of a background check (including criminal records check) is required prior to beginning employment. Any offer of employment may be rescinded if the background check reveals disqualifying information, and/or it is discovered that the candidate knowingly withheld or falsified information. Failure to satisfactorily complete the background check may affect the continued employment of a current NAI employee who was conditionally offered the position.
$49k-75k yearly est. 25d ago
QA Associate 1 - Lot Disposition
Pacira Pharmaceuticals 4.7
Quality assurance specialist job in San Diego, CA
At Pacira, innovation meets purpose. Pacira BioSciences, Inc. is a pioneer in non-opioid pain management and regenerative health solutions. Today, we're building on that legacy with next-generation innovations for chronic, postsurgical, and musculoskeletal pain. Our culture is built on collaboration, innovation, and a shared commitment to helping patients recover faster. We are redefining what's possible in pain management-and we can't do it without talented people like you.
Why Join Us?
At Pacira, every career is more than a job. Our mission drives us, and every day, we challenge ourselves to achieve the extraordinary. Integrity is at the core of who we are. We value diverse perspectives and the collective strength of a unified team. Join the team in making better possible for patients everywhere.
Purpose:
This person provides hands on quality assurance support to manufacturing operations with a primary focus on batch record review and lot release activities. This role supports the organization's commitment to GMP compliance by monitoring manufacturing activities, reviewing executed batch documentation, and ensuring conformance to established quality systems, procedures, and regulatory requirements. The QA I Associate works closely with cross-functional teams to identify and address quality risks while maintaining real-time floor presence to support compliant operations.
Responsibilities
Responsibilities:
* Maintain programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMP).
* Assist in the identification of risk and deficiencies while working with internal departments/business units to appropriately remedy them.
* Facilitate internal training on quality assurance requirements, processes, and procedures.
* Monitor for GMP compliance of all in-process activities during GMP processing.
* Perform AQL particle inspection of in-process product vials prior to packaging.
* Perform review of executed Batch Documentation and prepare for disposition.
* Perform all process steps for the Transfer and Shipment of Batch Records with management oversight.
* Search and document quality event reports for Batch Release.
* Maintain databases as required.
* Perform other duties as assigned.
Supervisory Responsibilities:
This person has no direct supervisor responsibilities.
Interaction
Continuously interacts with other members of the Manufacturing, Quality Control, Supply Operations, Microbiology and Product teams.
Qualifications
Education and Experience:
* 1 year of industry experience in the pharmaceutical or a closely related industry preferred
* BS/BA degree in scientific discipline desirable
Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This job requires weekend, holiday and off shift work hours.
Knowledge, Skills, and Abilities:
* Strong knowledge of GMP's and their application
* Prior experience with Batch Documentation review
* Ability to work proactively and cooperatively with managers and operational staff to solve quality problems
* Ability to manage multiple responsibilities with a high degree of self motivation
* Good written, oral and interpersonal communication skills
* Ability to use Microsoft Word and Excel applications
* Experience with Batch Record Review
* Experience with Visual Inspection and/or AQL Inspection
* Experience with working in a cleanroom environment
Work Environment:
Typical office setting, cubicles, noise level is moderate with consistent printer, telephone ringing and conversation. The work environment also includes warehouse and manufacturing areas.
Physical Demands:
While performing the duties of this job, the employee is regularly required to sit, move between spaces, and reach
with hands and arms. Close vision and the need to focus on computer screen, use of hands, fingers, and wrist to type
on keyboard and manipulate mouse. Will need to lift and move items weighing up to 30 pounds.
Employee is required to work in a cleanroom environment, which requires gowning consisting of coverall, foot and
head coverings, facemask, and gloves. Noise level is moderate with consistent equipment operation. This position requires the individual to pass the AQL particle inspection test of in process product vials.
Benefits
Benefits:
* Medical, Prescription, Dental, Vision Coverage
* Flexible Spending Account & Health Savings Account with Company match
* Employee Assistance Program
* Mental Health Resources
* Disability Coverage
* Life insurance
* Critical Illness and Accident Insurance
* Legal and Identity Theft Protection
* Pet Insurance
* Fertility and Maternity Assistance
* 401(k) with company match
* Flexible Time Off (FTO) and 11 paid holidays
* Paid Parental Leave
Pay Transparency
The base pay range for this role is $23.00 per hour. to $30.00 per hour. This role is classified as non-exempt and eligible for over-time. The range is what we reasonably expect to pay for this role. The range considers a wide range of factors that are considered in making compensation decisions, including but not limited to: geographic markets, business or organizational needs, skill sets, experience, training, licensure, and certifications.
EEO Statement
EEO Statement: Pacira is proud to be an Equal Opportunity Employer and does not discriminate against applicants because of race, color, religion, sex (including gender identity, sexual orientation, and pregnancy), national origin, age (40 or older), veteran status, disability or genetic information, or any other characteristic protected under applicable federal, state, or local law. At Pacira we are committed to intentionally cultivating a culture of inclusion where all feel welcomed and valued for their background, perspectives, and experiences. We hold one another accountable to promote trust and transparency in support of our communities and collective purpose.
Agency Disclaimer: Pacira Biosciences, Inc. (Hereafter, Pacira) does not accept unsolicited resumes from recruiters or employment agencies in response to the Pacira Careers page or a Pacira social media post. Pacira will not consider or agree to payment of any referral compensation or recruiter fee relating to unsolicited resumes. Pacira explicitly reserves the right to hire said candidate(s) without any financial obligation to the recruiter or agency. Any unsolicited resumes, including those submitted to hiring managers, are deemed to be the property of Pacira.
$23-30 hourly Auto-Apply 5d ago
Documentation Specialist
Olsa Resources
Quality assurance specialist job in Santa Ana, CA
(Santa Ana, CA 92705) Core Job Responsibilities: Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Document creation and revision of procedures to manage compliance during “transition” process Document creation and revision of Division level procedures for each Quality subsystem
Ensure document format consistency
Prepares, edits, files, assembles documentation such as reports or technical documents, records, or correspondence.
Proofreading and verifying own work
Verify integrity of Change Request packet
Processing of controlled documents per approved change requests in Agile document management system
Information mapping of documents
Responsible for management of version control, resolutions of conflicting changes, and working closely with the document owners to assure all needs are met.
Track document control and archival metrics for the department.
Maintenance of documents per corporate record retention schedules
Serving as the focal point for customer inquires for document requests/usage as it relates to Harmonized Quality System project
Support initiatives which may include attendance at project meetings
*****5 years plus experience and medical device experience****
Additional Information
Pay Rate: DOE but 23-27/hour
Shift: Monday-Friday, 8AM-5PM
5-6 months+ Contract
$41k-67k yearly est. 3d ago
Quality Assurance Auditor/Inspector
Wellington Foods Inc.
Quality assurance specialist job in Corona, CA
Job DescriptionSalary: $18-$23/hour
Under direct supervision of the Quality Systems & Regulator Compliance Department management, the Quality Assurance Auditor/Inspector is primarily responsible for auditing manufacturing operationsand quality systems for compliance with Good Manufacturing Practices, Good Documentation Practices, and other companys established manufacturing operations and quality policies.
ESSENTIAL FUNCTIONS:
Responsibilities include but are not limited to:
Enforce Current Good Manufacturing Practices (cGMPs) and Good Documentation Practices (GDPs) at all stages of the manufacturing process and in all places within the manufacturing areas.
Conduct routine walk-through in the manufacturing areas and other specified areas (such as restrooms, and break-rooms) to ensure that good housekeeping practices and good hygiene practices, which could affect the safety and quality of manufactured products, are followed.
Verify that all raw materials and packaging components are properly received, stored and segregated (allergen vs. non-allergen; organic vs. non-organic, etc.) in the warehouse for raw materials and packaging components.
Verify that processing equipment has been properly cleaned and sanitized in the staging/weighing rooms, compounding/batching rooms, powder blending rooms, filler and packaging rooms, etc.
Audit the weighing/staging process to ensure that the correct raw materials are used and in correct amounts as specified in the Ingredients Batch Record.
Audit the compounding/batching process to ensure that all raw materials allocated to the batch are indeed used and added to the batch in the sequence specified in the Manufacturing Instructions Batch Record.
Collect in-process samples from the batch (as specified) and perform all required tests (pH, Brix, sensory evaluation, etc.) before releasing the batch for further processing (such as thermal
processing) and packaging.
Collect samples of finished products (test samples, stability samples, and reserve samples), conduct specified testing and report testing results.
Perform all applicable line clearance and inspections which may include measuring the product fill levels or fill weights, proper label application and cap torque, inkjet legibility on bottles and cases, and proper pallet configuration.
Maintain all Quality and Production paperwork including bottle and cap tracking logs, shrink
sleeve tracking logs, area line clearances, room and equipment cleaning and sanitation, issuing of product specification sheets, etc.
Verify that all quality control instruments (balances, pH, refractometers, thermometers, etc.) are properly calibrated and performing up to specifications.
Sampling finished products for quality control laboratory, special testing such as stability studies, customer samples and maintaining reserve samples.
Perform AQL inspections of finished product when rework is conducted or as directed by Quality Systems & Regulatory Compliance Department Management.
Monitor the effectiveness of cleaning & sanitation (visual observation as well as using ATP bioluminescence method).
Monitoring the concentration of sanitizers such as peracetic acid (PAA), QUAT and ozone as applicable to ensure that the levels do not exceed or fall below specifications.
Assist in environmental monitoring (swabbing and air sampling) and pest control inspection.
Perform other duties as determined by the Quality Systems & Regulatory Compliance Department Management.
REQUIRED EDUCATION / EXPERIENCE / SKILLS:
Bachelors degree in food science and technology, biology, microbiology or other related disciplines or equivalent work experience (High School Diploma with at least 3 years of work experience in related field or industry)
Work experience in quality control/quality assurance operations in food, dietary supplement or pharmaceutical industry
Experience with GMP regulations and Good Documentation Practices
Sample collection experience is a plus.
$18-23 hourly 14d ago
Documents Specialist
Optima Tax Relief 4.2
Quality assurance specialist job in Santa Ana, CA
The Documents Specialist for Optima Tax Relief, LLC (“Optima”) is located in the Santa Ana, California office and reports to the Documents Specialist Team Lead or Mail Operations Team Lead. This role is heavily relied upon to ensure proper placement of client files to respective folders. This is done through either hardcopy mail (paper) or digital (email, fax, scan) so attention to detail is critical. This role requires high volumes of typing and organization and involves minimal phone work. This role must also champion Optima's culture and Core Values and help to deliver the best customer experience.
ESSENTIAL DUTIES & RESPONSIBILITIES
The essential functions include, but are not limited to the following:
Sort or "scrub" through uploaded files to identify client files for proper file placement.
Upload and organize client documents received within a 24 to 48 hour business time frame.
Rename and reorder documents or packages clients may send in through Optima's client portal.
Notify appropriate parties of documents received.
Follow company protocols to ensure the highest level of security to protect the client Personal Identifiable Information (PII).
Other duties as assigned.
In order to be provided the essential training required to be successful in this role, it is mandatory that you are present for and complete all essential/initial training onsite for up to 5 business days (unless prior management approval is provided). Please note that additional onsite training may be required depending on business need.
Qualifications
EDUCATION AND EXPERIENCE REQUIREMENTS
High school diploma or equivalent education required.
KNOWLEDGE, SKILLS,& ABILITIES
A positive mindset and "get-it-done" attitude.
Excellent organizational, time-management, written, and communication skills.
History of successfully exceeding goals in a fast-paced environment.
Strong work ethic and commitment to excellence.
Meticulous attention to detail and high sense of accountability.
Proficient and comfortable with office equipment (Computer skills - Microsoft Office, Outlook).
Self-starter, industrious, and motivated.
Strong ability to multi-task.
Team player.
$38k-49k yearly est. 21d ago
Digital Specialist I/Document Prep Specialist
VRC Metal Systems 3.4
Quality assurance specialist job in Tustin, CA
Requirements
Competencies:
Detailed knowledge of the digital scanning process including an understanding of how digital scanners work.
Ability to locate and select appropriate client files in the computer system for scanning into the appropriate location.
Able and willing to consistently report to work on time prepared to perform duties of position.
Understanding of the need to set and meet departmental productivity benchmarks and quality standards.
Well organized and detail oriented.
Able to work both on a team and individually.
Compensation is $18/hr. with $0.50 night shift differential.
Work Environment: Must be able to tolerate heat in the summer and cold in the winter.
Physical Demands: While performing the duties of this job, the employee is regularly required to stand and walk. The employee is occasionally required to sit, climb/balance, stoop, kneel, or crouch. Must be able to reach, handle, carry, and lift between 10 lbs. and up to 50 lbs. While performing job duties, the employee is regularly required to talk, hear, read, and identify numbers for accurate order filling and receiving of material.
Education and Eligibility Requirements
Must be able and willing to communicate effectively in English.
Must have skill and proficiency using a computer workstation and scanner systems.
Ability to trouble-shoot computer problems as they relate to electronic document conversion.
Must be able and willing to work overtime hours as needed.
Must have a positive and respectful attitude towards both coworkers and customers.
Must be able and willing to follow Company policies and procedures.
Other duties: Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the applicant for this job. Activities, duties, and responsibilities may change at any time with or without notice.
VRC is an Equal Opportunity Employer.
We are committed to creating an inclusive environment for all employees and applicants. We do not discriminate based on race, color, religion, national origin, gender, sexual orientation, gender identity or expression, age, disability, veteran status, marital status, or any other legally protected status. All qualified applicants will receive equal consideration for employment.
Job title: Document Review Specialist Document Review Specialist Pay: $18.00 hourly Document Review Specialist Schedule: 8am-5:00pm Monday-Friday
Review mortgage files for completeness and accuracy
Audit files to ensure files are complete with all required forms
Flag errors in the electronic system with any discrepancies found in documents
Compare information in the system against the information listed on the actual documents
Process trailing documents
File documents in alphabetical order
Perform 10-key Data entry
Entry Level Document Review Specialist/Clerical Requirements:
Previous data entry skills
Live Scan Background Screening required
Must have a HS/Diploma and or GED
Time management to ensure to meet all deadlines
$18 hourly 19d ago
Director, Quality Assurance
Cirsium Biosciences
Quality assurance specialist job in San Diego, CA
Cirsium Biosciences is creating the next generation of manufacturing technologies for viral vector production. Our novel plant-based platform solves the existing problems of speed, flexibility, scalability, and safety in viral vector manufacturing while dramatically reducing production costs. Our goal is to enable global and equitable access to life-changing genetic therapies. Position Overview
We are seeking a highly collaborative Director, Quality Assurance to join and lead the QA function for our growing organization. This strategic role will oversee all aspects of Quality, including the development, implementation, and management of GxP (cGMP, GCP, and GLP) quality systems. Our ideal candidate should have a strong knowledge of relevant regulations and be able to manage and work cross‑functionally to ensure compliance of Cirsium's ongoing development programs with local, state and federal requirements. This position will support developing a culture of quality, ensuring compliance with regulatory requirements, driving continuous improvement in quality systems, supporting the successful development, manufacturing, and commercialization of our unique products.
Key responsibilities
Assist with developing, implementing, and maintaining GxP compliant quality systems and processes to ensure compliance with FDA, EMA, ICH, and global competent authority regulations and industry guidance
Co- lead quality audits, risk assessments, and investigations, ensuring timely resolution of quality issues.
Work with the company's external suppliers and contract organizations to ensure consistent quality and compliance.
Prepare for and manage inspections by regulatory agencies and commercial partners, serving as a liaison between the Company and auditors, including reporting and follow-up to any finding
Work on qualification and validation plans, assure proper batch releases and disposition.
Oversee resolution of any product concerns, including investigation, tracking and corrective action plans (CAPA).
Provide quality input on contracts and serve as a point person for negotiations of quality agreements.
Champion a culture of quality and continuous improvement across manufacturing and development operations.
Qualifications
Bachelor's degree in biological sciences or related field, with a minimum of 7 or more years experience in Quality Assurance or related fields within the pharmaceutical or biotechnology industry
Extensive knowledge of GxP (GMP, GLP, and GCP) regulations and guidelines, including FDA, EMA, and ICH requirements
Demonstrated hands‑on experience working on complex projects.
In‑depth knowledge of FDA, EMA, and ICH guidelines, regulations, and processes related to CMC.
Strong partnering and communication skills required, as well as project management skills.
Must be focused on working collaboratively and within our values of: Data rules, All‑in, Own it (Accountable), Caring and Humble.
Ability to work effectively in a collaborative, fast‑paced environment.
Strong analytical skills, excellent problem‑solving skills, and innovative thinking for sustainable practices.
Strong organizational and time‑management skills with the ability to handle multiple projects.
Excellent leadership and communication skills, and the ability to work in a collaborative, fast‑paced environment.
Generous PTO Health Insurance & Health Savings Account Vision Insurance Employee Assistance Program (EAP) Stock Options Professional Development Opportunities 401(k) Plan Life & AD&D Insurance And More...
Cirsium Biosciences is an emerging company located in San Diego, California. We offer highly competitive compensation and employee programs, including comprehensive health, dental and vision plans, generous time off, and equity in our early‑stage company. We are dedicated to fostering a workplace that keeps our team inspired and engaged. We offer an inclusive company culture where employees feel respected and valued.
Cirsium Biosciences is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation, veteran status, or any other protected categories. #J-18808-Ljbffr
$131k-214k yearly est. 3d ago
Learn more about quality assurance specialist jobs
How much does a quality assurance specialist earn in Oceanside, CA?
The average quality assurance specialist in Oceanside, CA earns between $45,000 and $118,000 annually. This compares to the national average quality assurance specialist range of $41,000 to $97,000.
Average quality assurance specialist salary in Oceanside, CA
$73,000
What are the biggest employers of Quality Assurance Specialists in Oceanside, CA?
The biggest employers of Quality Assurance Specialists in Oceanside, CA are: