The application window is expected to close on: Feb 20th, 2026
NOTE: Job posting may be removed earlier if the position is filled or if a sufficient number of applications are received.
Meet the Team
We are SaaS Engineering organization within the Cisco Networking Engineering. We are committed to revolutionizing the deployment of generative AI applications! Our mission is to improve IT visibility and deliver comprehensive analytics for the AI infrastructure stack. By applying innovative technologies, we are developing next-generation SaaS-based controllers crafted to efficiently manage Data Centers with AI/ML solutions.
Your Impact
You will work on Cisco HyperFabric, an innovative cloud-operated AI cluster solution. Cisco HyperFabric aims to provide customers with a unified compute and networking fabric, along with a management system that enables the creation of easily deployable, scalable, and manageable AI/ML solutions.
As a Software Development Manager, QA, you will be leading a team of talented QA and Customer Support Engineers. You develop and execute a test strategy for our solutions. The ideal candidates should have a strong curiosity and experience in QA across various systems, as well as demonstrated leadership skills in software development and system configuration automation. You will be responsible for the following:
Lead a focused and collaborative team environment by empowering senior team members to operate independently while fostering strong cross-functional teamwork among backend, UI development, and QA functions
Drive QA team efficiency and agility by ensuring effective coordination, clear prioritization of features, and continuous improvement of processes.
Oversee and own the continuous deployment pipeline, ensuring smooth and reliable execution across multiple environments with the QA team managing and optimizing the process end-to-end.
Cultivate a startup-like atmosphere that emphasizes innovation and collaboration without rigid processes, allowing development and QA teams to jointly own code and test responsibilities while leveraging custom testing solutions.
Collaborate with the internal teams to address customer issues efficiently and effectively, ensuring a seamless experience.
Minimum Qualifications:
Bachelors in an engineering field with 12 + years of experience or Master's degree with 8 + years of experience.
5+ years of prior experience as a manager of a QA Engineering team.
Knowledge of networking technology and SaaS environment.
Experience with robust testing and validation of networking software for optimizing performance, reliability, and security.
Preferred Qualifications:
Experience in Python for testing. Experience with automation and testing frameworks to streamline and enhance the quality assurance processes.
Strong experience in QA coordination, planning, and prioritizing of features.
Proven track record in managing continuous deployment pipelines and owning QA processes across multiple environments.
Deep understanding of data network technology, experience in customer-facing roles and customer support best practices.
4+ years of experience in Customer Success or related roles, preferably in a SaaS networking domain.
Experience in guiding the customers through the initial setup, implementation, and training phases to ensure successful product adoption and a smooth start to their journey.
Why Cisco?
At Cisco, we're revolutionizing how data and infrastructure connect and protect organizations in the AI era - and beyond. We've been innovating fearlessly for 40 years to create solutions that power how humans and technology work together across the physical and digital worlds. These solutions provide customers with unparalleled security, visibility, and insights across the entire digital footprint.
Fueled by the depth and breadth of our technology, we experiment and create meaningful solutions. Add to that our worldwide network of doers and experts, and you'll see that the opportunities to grow and build are limitless. We work as a team, collaborating with empathy to make really big things happen on a global scale. Because our solutions are everywhere, our impact is everywhere.
We are Cisco, and our power starts with you.
Message to applicants applying to work in the U.S. and/or Canada:The starting salary range posted for this position is $210,600.00 to $305,100.00 and reflects the projected salary range for new hires in this position in U.S. and/or Canada locations, not including incentive compensation*, equity, or benefits.
Individual pay is determined by the candidate's hiring location, market conditions, job-related skillset, experience, qualifications, education, certifications, and/or training. The full salary range for certain locations is listed below. For locations not listed below, the recruiter can share more details about compensation for the role in your location during the hiring process.
U.S. employees are offered benefits, subject to Cisco's plan eligibility rules, which include medical, dental and vision insurance, a 401(k) plan with a Cisco matching contribution, paid parental leave, short and long-term disability coverage, and basic life insurance. Please see the Cisco careers site to discover more benefits and perks. Employees may be eligible to receive grants of Cisco restricted stock units, which vest following continued employment with Cisco for defined periods of time.
U.S. employees are eligible for paid time away as described below, subject to Cisco's policies:
10 paid holidays per full calendar year, plus 1 floating holiday for non-exempt employees
1 paid day off for employee's birthday, paid year-end holiday shutdown, and 4 paid days off for personal wellness determined by Cisco
Non-exempt employees** receive 16 days of paid vacation time per full calendar year, accrued at rate of 4.92 hours per pay period for full-time employees
Exempt employees participate in Cisco's flexible vacation time off program, which has no defined limit on how much vacation time eligible employees may use (subject to availability and some business limitations)
80 hours of sick time off provided on hire date and each January 1st thereafter, and up to 80 hours ofunused sick timecarried forwardfrom one calendar yearto the next
Additional paid time away may be requested to deal with critical or emergency issues for family members
Optional 10 paid days per full calendar year to volunteer
For non-sales roles, employees are also eligible to earn annual bonuses subject to Cisco's policies.
Employees on sales plans earn performance-based incentive pay on top of their base salary, which is split between quota and non-quota components, subject to the applicable Cisco plan. For quota-based incentive pay, Cisco typically pays as follows:
.75% of incentive target for each 1% of revenue attainment up to 50% of quota;
1.5% of incentive target for each 1% of attainment between 50% and 75%;
1% of incentive target for each 1% of attainment between 75% and 100%; and
Once performance exceeds 100% attainment, incentive rates are at or above 1% for each 1% of attainment with no cap on incentive compensation.
For non-quota-based sales performance elements such as strategic sales objectives, Cisco may pay 0% up to 125% of target. Cisco sales plans do not have a minimum threshold of performance for sales incentive compensation to be paid.
The applicable full salary ranges for this position, by specific state, are listed below:
New York City Metro Area:
$210,600.00 - $350,800.00
Non-Metro New York state & Washington state:
$189,300.00 - $312,200.00
* For quota-based sales roles on Cisco's sales plan, the ranges provided in this posting include base pay and sales target incentive compensation combined.
** Employees in Illinois, whether exempt or non-exempt, will participate in a unique time off program to meet local requirements.
$210.6k-350.8k yearly 2d ago
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Quality System Manager- ISO (26953)
Supermicro 4.7
Quality assurance specialist job in San Jose, CA
Supermicro is the leading innovator in high-performance, high-efficiency server technology, is a premier provider of advanced server Building Block Solutions for Data Center, Cloud Computing, Enterprise IT, Hadoop/Big Data, HPC and Embedded Systems worldwide. Supermicro is committed to protecting the environment through its "We Keep IT Green" initiative and provides customers with the most energy-efficient, environmentally-friendly solutions available on the market.
Job Summary:
This position works directly with multiple teams to support the development and implementation of a proactive Quality Management System, Environmental Management System (EMS), and Information Security Management (ISM) in compliance with ISO 9001 / 13485 / 14001 / 27001 globally. This includes the creation, training, deployment, auditing, and maintenance of the global Supermicro Quality and Environmental Managements Systems.
The Quality Systems Manager will provide leadership in the implementation, maintenance, and improvement of company-wide Quality Management System, Environmental Management System (EMS), and Information Security Management (ISM), procedures and support processes. Proactively monitors the various elements of the QMS, EMS and ISM to help ensure compliance with quality and environmental system regulations and applicable national and international standards.
Essential Duties and Responsibilities:
Provide support to internal functions in the application, maintenance and improvement of quality systems, procedures and department specific processes;
Coordinate external audits by the Notified Body, other regulatory bodies and third parties, and coordinates responses to applicable audit findings;
Prepare performance reports and metrics for the QMS, EMS and ISM;
Ensure efficient and effective processes and tools are established for compliance with ISO standards requirements;
Serve as the process owner and subject matter expert for key elements of the QMS, EMS and ISM, including CAPA, Complaint Handling and Internal Audit.
Lead / participate in company-wide internal audit program including planning, implementation, report generation, corrective action issuance to closure;
Conduct local and global training on key elements of the QMS, EMS and ISM, including CAPA, Complaint and Internal Audit.
Execute projects and complete other duties as assigned.
Please note that this position requires regular in-office attendance. The successful candidate is expected to be present in the office during standard working hours as determined by the company. In-office collaboration and participation in team meetings, training sessions, and other on-site activities are essential aspects of this role. Candidates should consider the commuting distance and be prepared to fulfill their responsibilities in the designated office location.
Qualifications:
Bachelor's degree in General Business, Engineering, Science, or a related field
Minimum of 8 years of working experience in a relevant quality or compliance-related field, with at least 5 years of direct experience managing Quality / Environmental Management Systems (Q/EMS)
Proven experience in developing and managing QMS, EMS, and ISMS within manufacturing, electronics, semiconductor, pharmaceutical, or medical device industries.
Strong knowledge and practical application of ISO and international standards, including but not limited to:
ISO 9001 (Quality Management)
ISO 13485 (Medical Devices)
ISO 14001 (Environmental Management)
ISO 27001 (Information Security)
AS9100 (Aerospace Quality Systems)
Demonstrated influence management skills, with the ability to collaborate effectively across departments, and engage with both customers and suppliers.
Excellent communication and presentation skills - confident, articulate, and persuasive in both verbal and written formats.
Proven leadership and team management abilities, including:
Developing and executing strategic plans
Defining clear roles, responsibilities, and performance expectations
Providing hands-on support when needed (e.g., conducting audits, leading process reviews)
Strong organizational and multi-tasking skills.
Working knowledge and practical application of risk assessment methodologies (e.g., FMEA) and key performance indicators (KPIs) for process monitoring and improvement.
Willingness to travel as needed; 10-20% domestic and/or international travel may be required.
EEO Statement
Supermicro is an Equal Opportunity Employer and embraces diversity in our employee population. It is the policy of Supermicro to provide equal opportunity to all qualified applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status or special disabled veteran, marital status, pregnancy, genetic information, or any other legally protected status.
Salary Range: $115,000 - $135,000 / Annual
The salary offered will depend on several factors, including your location, level, education, training, specific skills, years of experience, and comparison to other employees already in this role. In addition to a comprehensive benefits package, candidates may be eligible for other forms of compensation, such as participation in bonus and equity award programs.
$115k-135k yearly 2d ago
QA Automation Engineer
Teksystems 4.4
Quality assurance specialist job in Walnut Creek, CA
Our Client is looking for an automation engineer with extensive software QA technical expertise to join our dynamic QA team. This individual will design, develop, and maintain test scripts and automation Frameworks. The ideal candidate should have strong experience in Selenium/Python, Playwright/TypeScript and C Sharp , along with a deep understanding of UI, API and Database automation environments.
KEY RESPONSIBILITIES
Design, develop, and maintain automation for various applications - UI, API and Databases.
Review in detail, test plans and test cases to transform them into automation regressions.
Collaborate with QA team members and other stakeholders to understand test requirements and implement automation.
Implement best practices for DevOps and CI/CD pipelines, ensuring smooth and automated deployments across environments.
Participate in automation code reviews, providing constructive feedback to peers and ensuring high code quality and adherence to coding standards.
Collaborate with Development teams to performance and load test applications and services, providing automation test support.
Implement best practices for test automation dashboards for modern SRE (Site Reliability Engineering) purposes.
Stay up to date with new technology trends and frameworks.
Work with the infrastructure team to ensure automation framework environments are stable, secure, and meet business performance expectations.
Document automation process - coding guidelines, reviews, check-ins, execution and test results.
RISK AND COMPLIANCE
Ensure that all business applications comply with industry regulations and internal security standards, including SOX, PCI-DSS, and other financial sector regulations.
Work with the cybersecurity team to ensure applications are secured against potential threats and vulnerabilities.
Develop and maintain test documentation, including test scripts, and test data management.
Implement processes to ensure traceability of test cases to requirements and automated defect tracking/reporting.
Work with Agile/Scrum software development processes to implement version control automation and deployments.
*Skills*
Automation
*Top Skills Details*
Automation
*Additional Skills & Qualifications*
Looking for someone with good communication skills and personality that will get along well with the team.
*Experience Level*
Intermediate Level
*Job Type & Location*This is a Contract to Hire position based out of Walnut Creek, CA.
*Pay and Benefits*The pay range for this position is $50.00 - $68.00/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 hybrid position in Walnut Creek,CA.
*Application Deadline*This position is anticipated to close on Jan 19, 2026.
h4>About TEKsystems:
We're partners in transformation. We help clients activate ideas and solutions to take advantage of a new world of opportunity. We are a team of 80,000 strong, working with over 6,000 clients, including 80% of the Fortune 500, across North America, Europe and Asia. As an industry leader in Full-Stack Technology Services, Talent Services, and real-world application, we work with progressive leaders to drive change. That's the power of true partnership. TEKsystems is an Allegis Group company.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
About TEKsystems and TEKsystems Global Services
We're a leading provider of business and technology services. We accelerate business transformation for our customers. Our expertise in strategy, design, execution and operations unlocks business value through a range of solutions. We're a team of 80,000 strong, working with over 6,000 customers, including 80% of the Fortune 500 across North America, Europe and Asia, who partner with us for our scale, full-stack capabilities and speed. We're strategic thinkers, hands-on collaborators, helping customers capitalize on change and master the momentum of technology. We're building tomorrow by delivering business outcomes and making positive impacts in our global communities. TEKsystems and TEKsystems Global Services are Allegis Group companies. Learn more at TEKsystems.com.
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.
$50-68 hourly 2d ago
Manufacturing/ Packaging QA Auditor
Us Tech Solutions 4.4
Quality assurance specialist job in Milpitas, CA
+ **Shift Hours: 6-4:30 PM PST+ OT as needed.** + Responsible for the final quality audit before shipment of systems, upgrades, and miscellaneous ship kits. + Collaborate closely with Manufacturing, Manufacturing Engineering, Master Scheduling, Production Control, Material handlers, Dock personnel and Packing contractors to ensure audits and quality inspections are completed so that products ship on time.
+ Demonstrate proficiency with SAP SW as well as the MS Office suite.
+ Clear communication and strong collaborative skills
+ Persevere against challenging and time constrained issues.
+ Inventing creative solutions to problems to ensure the job gets done on time.
+ Provide constructive process improvement recommendations.
+ Redline procedures as appropriate.
+ Assist in the training and development of new hires.
+ Support other product lines in plant clearance activities when necessary.
**Responsibilities:**
+ Auditing material against BOMs.
+ Evaluating the quality of packaging.
+ Visual spot check of part quality.
+ Ensure proper labelling of parts.
+ Consolidating piece parts into the correct shipping bin.
+ Working with Production Control and/or Manufacturing Engineering to resolve issues.
+ Coordinate material movement out of clean room.
+ Creating and maintaining Plant Clearance audit records.
**Experience:**
+ Quality Control exp. for Packaging & Production audits for semiconductor or manufacturing clients
**Skills:**
+ Auditing material against BOMs
+ Quality Control
+ SAP SW
+ MS Office suite
**Education:**
+ HS or equivalent practical experience.
**About US Tech Solutions:**
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit *********************** .
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Position:Full-Time Total Rewards: Benefits/Incentive Information
If you've worn a pair of glasses, we've already met.
We are a global leader in the design, manufacture, and distribution of ophthalmic lenses, frames, and sunglasses. We offer our industry stakeholders in over 150 countries access to a global platform of high-quality vision care products such as the Essilor brand, with Varilux, Crizal, Eyezen, Stellest and Transitions, iconic brands that consumers love such as Ray-Ban, Oakley, Persol and Oliver Peoples, as well as a network that offers consumers high-quality vision care and best-in-class shopping experiences such as Sunglass Hut, LensCrafters, and Target Optical, and leading e-commerce platforms.
Our unique business model and relentless pursuit of operational excellence ensures that consumers everywhere have access to products. Balancing speed, efficiency and proximity, the Company manages a global supply chain with cutting-edge technology, based on centralization for frames and on a capillary network for lens finishing and prescription laboratories. In our dynamic environment, fueled by technology and innovation, our people have the space to pioneer new solutions.
Oakley is part of EssilorLuxottica. Building on our legacy of innovative, market-leading optical technology, we manufacture and distribute high performance sunglasses, prescription lenses and frames, goggles, apparel, footwear, and accessories. Every day at Oakley is a chance to grow, go further and achieve more.
Join our global community of over 200,000 dedicated employees around the world in driving the transformation of the eyewear and eyecare industry. Discover more by following us on LinkedIn!
GENERAL FUNCTIONS
The Sr. Quality Manager leads Oakley's Manufacturing Quality Program related to eyewear finished goods, injection molding, painting processes and related quality engineering functions.
MAJOR DUTIES AND RESPONSIBILITIES
Drives analysis related to Oakley's Internal Quality Cost of Quality & Topics of Extra Consumption (Scrap) & alignment for improvement projects.
Leads efforts & focus on product quality problems and gives direction to systematically drive improvements for those problems (Related to external and internal complaints like LQS, and Quality Service Levels).
Drives in improvement projects based on Market data and After Sales input.
Structures and works with a wide range technical issue and understands product performance requirements and the efforts to manage the Quality Team in meeting expectations.
Be a subject matter expert for quality to works globally with other EssilorLuxottica facilities producing Oakley products and align the brand expectations to streamline processes.
Collaborates to create a strong partnership with each Business Unit; Engineering, Manufacturing and other end to end supply chain functions.
Responsible for annual budgeting to align with Annual Operating Plan and / or 3 to 5 year manufacturing forecast.
Attracts, retains and mentors the highest caliber quality engineering personnel
Drives a culture where Safety is the number one priority. Maintains a safe, organized and clean working environment by complying with procedures, rules, and regulations
Leads a team of approximately at least 8 direct reports (Quality Engineers and Supervisors working on multiple shifts) and at least 30 indirect reports (QA Leads, Technicians).
Performs other duties and responsibilities as needed.
Works safely and maintains a safe, organized and clean working environment by complying with procedures, rules, and regulations.
BASIC QUALIFICATIONS
Bachelor's Degree in Engineering or related field
8+ years of experience in Quality Department
5+ years of management/leadership experience
Experience leading Quality Engineers / Managers in a manner that drives the Quality culture in a fast paced MFG environment
Working Knowledge of Quality Systems, quality process controls, material performance testing and has a solid understanding of Advanced Product Quality Planning
Experience supporting the overall business goals as they relate to the Quality team/leadership
PREFERRED QUALIFICATIONS
Master's Degree preferred
ASQ, Lean Manufacturing or Six Sigma certification
Pay Range: $128,455.38 - $181,424.38
Employee pay is determined by multiple factors, including geography, experience, qualifications, skills and local minimum wage requirements. In addition, you may also be offered a competitive bonus and/or commission plan, which complements a first-class total rewards package. Benefits may include health care, retirement savings, paid time off/vacation, and various employee discounts.
EssilorLuxottica complies with all applicable laws related to the application and hiring process. If you would like to provide feedback regarding an active job posting, or if you are an individual with a disability who would like to request a reasonable accommodation, please call the EssilorLuxottica SpeakUp Hotline at ************ (be sure to provide your name, job id number, and contact information so that we may follow up in a timely manner) or email ********************************.
We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, gender, national origin, social origin, social condition, being perceived as a victim of domestic violence, sexual aggression or stalking, religion, age, disability, sexual orientation, gender identity or expression, citizenship, ancestry, veteran or military status, marital status, pregnancy (including unlawful discrimination on the basis of a legally protected pregnancy or maternity leave), genetic information or any other characteristics protected by law. Native Americans in the US receive preference in accordance with Tribal Law.
$128.5k-181.4k yearly 48d ago
Quality Assurance Specialist
Microbac Laboratories, Inc. 4.0
Quality assurance specialist job in Turlock, CA
Come join our family! Microbac Laboratories is an essential business offering competitive pay and benefits including medical, dental, vision, life insurance, disability, generous paid time off including vacation, holidays and flex-time, a wellness program, referral bonus, tuition reimbursement and more!
Whether you are just starting your career in science or looking to further it, Microbac will put you on the path of an exciting career with room to grow. Quality, safety, giving back to our communities, diversity and inclusion, customer success and employee wellbeing are part of our core culture. We are looking for motivated individuals to join our family as a Quality AssuranceSpecialist.
ABOUT MICROBAC
Microbac Laboratories, Inc. is a premier commercial laboratory testing firm that partners with clients worldwide, offering laboratory solutions to the life science, food and nutrition, and environmental industries and serves our clients with the utmost expertise and respect for their market requirements, constraints and challenges. We embody a company-wide commitment to exceptional customer experience, which has been refined over nearly 50 years of trusted, analytical and measurement experience.
Through our network of laboratories, offices, and field services, we have the flexibility to meet the unique requirements for each client, project and scope.
As a privately held third-party testing company, Microbac operates with a commitment to safety, quality and compliance. Our diverse work portfolio includes broad accreditation offerings and tested insights across the environmental, food and life science markets.
JOB SUMMARY
Under the direction of the Regional Quality Manager, the Quality AssuranceSpecialist, which functions independent from laboratory operations, oversees the development, implementation, and maintenance of quality systems throughout accredited commercial laboratories in Turlock, CA and the Western Region and ensures that relevant licenses and accreditations are obtained and maintained. This role will further ensure compliance with all relevant regulatory and company standards while ensuring traceable and defensible data.
ESSENTIAL FUNCTIONS
Is responsible for ensuring that effective and current quality systems are in place and adhered to by all staff, and that the data produced by the laboratory is of the highest quality (i.e.: accurate and defensible).
Serves as the focal point for QA/QC and is responsible for the oversight and/or review of quality control data such as data, control charts, calibration records, and other QA/QC data.
KEY RESPONSIBILITIES & ACCOUNTABILITIES
Ensures that the management system is established, implemented, and maintained in accordance with the applicable standards in their laboratory and by the use of Microbac's Intellect QMS system
Serves as the focal point for QA/QC; has a general knowledge of the analytical methods for which data review is performed, documented training and/or experience in QA/QC procedures and is responsible for the oversight and/or review of quality control data.
Functions independently from laboratory operations for which they have oversight being able to evaluate data objectively and perform assessments without outside influence
Maintains a master list of current versions of local quality documentation; handles the distribution locally maintained documents.
Trains personnel on the management system.
Monitors the corrective action process.
Notifies laboratory management of deficiencies in the quality system.
Oversees the laboratory's proficiency testing program
Coordinates laboratory accreditation activities
Leads, plans, organizes, and supports the activities and resources related to implementing and maintaining effective quality systems throughout the laboratory including but not limited to document control, CAPA, internal audits, control charts & trend analysis, in-depth data monitoring, approved suppliers and validation of methods, systems & instrumentation
Responsible for continual improvement of the management system through use of control charts and other method performance indicators; e.g., PT samples, internal and external audits.
Writes, reviews and revises SOPs and technical reports
Ensures the laboratory is fully compliant with all relevant regulatory standards
Prepares monthly reports both to local divisional management and to the corporate quality team summarizing quality activities at the laboratory
Serves as the laboratory contact for the Ethics and Data Integrity Program
Hosts and responds to client audits, leads the process to ensure observations are addressed
MINIMUM REQUIREMENTS
Bachelor's degree from a four-year accredited institution in a related field and two years of related experience or 5 years work experience in lieu of a degree
Knowledge of applicable management system standards ISO17025, TNI (NELAC) and preferably CA ELAP Regulations
Knowledge of accreditation and/or certification processes.
Desired field of degree: Quality Assurance, Regulatory Affairs, Chemistry, Biology or a closely related field.
JOB REQUIREMENTS
General knowledge of analytical test methods for which data review is performed.
General knowledge of applicable quality systems and accreditation, licensing and/or certification requirements.
Demonstrated leadership ability.
Ability to effectively prioritize work and manage time to meet deadlines and rush orders
Excellent communication skills.
Ability to work effectively with cross-functional teams.
Use of both paper and electronic documents and files, chromatography data systems, or other instrumentation software.
Ability to work in Quality Management System software system and Microsoft Office Suite
PHYSICAL REQUIRMENTS AND WORKING CONDITIONS
The physical demands and working conditions described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Physical Requirements:
The physical demands described here are representative of those that must be met to successfully perform the essential functions of this job. Reasonable accommodations may also be made to enable individuals with disabilities to perform the essential functions in accordance with applicable law. While performing the duties of this job, incumbent is regularly required to use hands and fingers to feel objects, tools or controls. Position requires standing, sitting, walking and reaching with hands and/or arms, talking clearly and/or hearing and understanding. Position often requires climbing, balancing, stooping or kneeling and occasionally lifting up to 30 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
Working Conditions:
While performing the duties of this job, the employee will be in a general office environment.
The noise level in the work environment is usually moderate.
This job will require travel to other laboratories in the Western Region.
OTHER:
This is not an exhaustive list of all duties an employee may be required to perform. Microbac reserves the right to revise the job description at any time.
Employment is at-will. Microbac, promotes a drug-free, alcohol-free workplace. Applicants considered for hire must pass a drug test before beginning work. Refusal to submit to testing will result in disqualification of further employment consideration.
Microbac is an Equal Opportunity Employer - We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. All qualified applicants will receive consideration for employment.
$66k-103k yearly est. Auto-Apply 11d ago
Quality Assurance (QA) Specialist III
Revance 4.2
Quality assurance specialist job in Newark, CA
The Quality Assurance (QA) Specialist III is an advanced level position with hands-on QA experience. Working independently and under minimal supervision, the individual will be working primarily in quality operations, providing quality assurance support to CMC teams, and to in-house DS and DP production, QC testing and systems. The individual will be interacting with cross-functional groups such as Materials Management, Validation, Quality Control, and Manufacturing.
Reporting to: Sr. Manager, Quality Assurance
Location: Newark, CA - onsite
Salary Range: $90,000 - $105,000 annually + annual performance bonus
* the final salary offered will depend upon factors that may include but are not limited to the quality and length of experience, education and geographic location.
Responsibilities/Essential Duties:
Perform a wide variety of quality assurance activities to ensure compliance with Revance procedures, applicable US and international regulatory requirements for biologic drug substances and drug products under clinical development and commercial manufacturing.
Perform incoming quality attribute inspections; review and disposition of incoming raw materials (e.g. chemicals, packaging and labeling materials, components, etc.).
Review documents such as standard operating procedures, master batch records, packaging and labeling records, sampling plans, test methods, qualification protocols, and reports.
Review executed production batch records and associated documentation, including any deviation and investigation reports related to lot release.
Review of Quality Control, Analytical Development, and Validation protocols and reports.
Perform routine sampling and support the reserve sample program.
Perform area approval, line clearance, and product inspection.
Perform product complaints investigations.
Actively update department databases to ensure up-to-date reporting of metrics.
Support continuous improvement of quality operations and department databases; author new, review existing, and may review department procedures and/or forms.
Support quality systems as needed (e.g. issue and track closure to change controls, deviations, quality investigations, CAPAs).
Assist with inspection preparation room for regulatory agency inspection or third-party audits.
Act as a compliance resource to provide guidance and assistance towards resolution of simple to moderate deviations, quality investigations, lab investigations, CAPAs and change controls; review and may approve quality system documents related to manufactured products.
Assist in data verification of DS and DP sections of regulatory submissions as needed.
Assist with internal compliance audits as needed.
Basic Qualifications:
Bachelor's degree & 4-6 years' directly related experience.
Preferred Qualifications:
Bachelor's degree in biology, chemistry, or related science.
Minimum 4-6 years' experience in the pharmaceutical or biotechnology industries, with at least 4 years working in direct manufacturing, Quality Control, or Quality Assurance; experience in aseptic manufacturing processes.
Able to work with all levels cross-functionally.
Good working knowledge and understanding of 21 CFR Parts 210, 211, 600, Eudralex Volume 4 and related Annexes, and ICH guidance documents.
6 years' experience in the pharmaceutical or biotechnology industry with at least 4 years working in quality operations involving aseptic fill, finish, and packaging operations.
Excellent interpersonal, verbal, and written communication skills.
Good working knowledge of quality systems cGMP standards applicable to commercial biologics DS and DP.
Works independently with minimum supervision to accomplish goals.
Relies on extensive experience and judgement to resolve simple to moderately complex issues.
Able to organize and manage multiple tasks in a fast-paced environment, with no instruction on routine work and general instructions on new assignments.
Prior experience with regulatory inspections.
Specific vision abilities required by this job include passing a vision test in order to perform statistical inspections of drug products.
While performing the duties of this job, the employee is regularly required to stand or sit, converse and listen to individuals, use arms and legs to transfer materials from one location to another, and use hands and fingers to operate a computer and telephone keyboard.
This job will require the employee to be able to multi-task different activities and be able to perform duties with attention to detail.
The business office has moderate noise from computers, phones, printers, and people traffic.
Company Summary:
Revance is a fast-growing global aesthetics and skincare company focused on providing innovative aesthetics and market-leading skincare offerings throughout every stage of life. With a differentiated portfolio of products spanning 60 countries, Revance meets the evolving needs of patients and consumers worldwide through continued innovation and commercialization of new products and treatments.
What Revance invests in you:
Competitive Compensation including base salary and annual performance bonus.
Flexible PTO, holidays, and parental leave.
Generous healthcare benefits, HSA match, 401k match, employer paid life and disability insurance, pet insurance, wellness discounts and much more!
This section of the is required by the American with Disability Act (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a “qualified individual with a disability” in all aspects of the employment relationship. A “qualified individual with a disability” is “an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job.”
Revance is an Equal Opportunity employer. All qualified applicants will receive consideration for employment based on merit, without regard to race, color, religion, sex, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.
$90k-105k yearly Auto-Apply 14d ago
Quality Specialist - Supplier Assurance Devices
DBA: Zeiss Group
Quality assurance specialist job in Dublin, CA
About Us: How many companies can say they've been in business for over 179 years?! Here at ZEISS, we certainly can! As the pioneers of science, ZEISS handles the everchanging environments in a fast-paced world, meeting it with cutting edge of technologies and continuous advancements. ZEISS believes that innovation and technology are the key to a sustainable future and solutions for global change. We have a diverse range of portfolios throughout the ZEISS family in segments like, Industrial Quality & Research, Medical Technology, Consumer Markets and Semiconductor Manufacturing Technology. We are a global company with over 42,000 employees and have over 4,000 in the US and Canada alone! Make a difference, come join the team!
Location/Region: This position is located in Dublin, CA
What's the role?
As a Supplier Quality AssuranceSpecialist, you will play a critical role in ensuring the quality and reliability of products sourced from external suppliers. Your primary responsibility will be to implement and maintain robust quality assurance processes across the supply chain to mitigate risks, drive continuous improvement, and up-hold the highest standards of product quality. You will work closely with suppliers, internal stakeholders, and cross-functional teams to evaluate supplier capabilities, assess quality performance, and drive corrective actions where necessary. Your expertise will directly impact on the safety, reliability and efficacy of the medical devices we produce and help us meet regulatory requirements and industry standards. Your expertise will directly impact on the safety, reliability and efficacy of the medical devices we produce and help us meet regulatory requirements and industry standards.
Sound Interesting?
Here's what you'll do:
Quality Compliance
* Ensure that all incoming goods adhere to relevant regulatory requirements, industry standards, and the company's quality management system
* Ensure that all supplier complaints are managed in compliance with relevant regulations, industry standards and company procedures
* Ensure that the records generated in incoming goods inspection and complaints management are detailed, comprehensible, up-to-date and are archived according to specified requirements.
* Responsible for maintaining the infrastructure within the SQA department (e.g. administration and release of test equipment, that valid inspection instructions are used, contributing to the validation of processes/methods, etc.)
* Responsible for representing supplier quality processes in internal and third-party audits
* Participation in supplier audits as Expert or Co. Auditor, Lead of audit scopes
Quality Control (Incoming Inspections)
* Responsible for the implementation, execution and improvement of incoming inspection and first article inspection activities
* Maintain records of inspection results, document and report any discrepancies, defects or non-conformities identified during inspections
* Initiates follow up actions in case of non-conformities in coordination with other departments and/or suppliers
* Maintain and communicate KPI's from incoming goods inspection and take actions as needed
Managing Supplier Non-Conformities
* Responsible for the implementation, execution and improvement of non-conforming material management activities related to suppliers
* Maintain detailed and accurate records of all supplier complaints, investigations, and resolutions in the complaints management system.
* Work closely with internal teams and suppliers to address quality issues, drive root cause analyses, and ensure timely and effective corrective and preventive actions (e.g. in LCM, Change Controls, CAPAs,…)
* Maintain open and transparent communication with suppliers throughout the complaint handling process
* Maintain and communicate KPI's from supplier complaints and take actions as needed
Increase Supplier Performance
* Responsible for the quality performance of assigned suppliers
* Monitor and assess supplier performance regularly, identifying areas for improvement and implementing necessary corrective and preventive actions when deviations occur
* Maintain accurate and up-to-date supplier quality records and documentation
* Identify opportunities for process improvements to enhance the efficiency and effectiveness of Supplier Quality Processes and implement process improvements.
Do you qualify?
* Bachelor of /Engineering/Science or comparable, required
* Minimum 5 years work experience in quality assurance or related roles in quality
* Minimum 5 years in complaint handling
* Extensive knowledge in quality assurance, complaint handling or supplier management, preferably in the medical devices industry
* Analytical mindset with the ability to identify trends and implement data-driven decisions
* Expert in interpretation of technical drawing (GD&T) and AQL sampling plan
* Experience in modern manufacturing technologies in the fields of mechanics/optics/electronics
* Familiarity with measurement tools and equipment used in quality inspection (e.g., calipers, micrometers, 3D CMM, preferably Zeiss Calypso)
* Experience on PCBA inspections certified on IPC-A- 610 Standard for Visual acceptability of electronic assemblies
* Advanced knowledge of quality assurance and quality management systems, ISO 13485 and ISO 9001. Knowing MDR + FDA requirements is an advantage
* Understanding of MSA, GR&R studies, Gage Repeatability and Reproducibility
* Excellent communication skills, both written and verbal, to effectively communicate with internal teams and suppliers
* Several years of experience in the application of methods and tools in quality management (such as SIX SIGMA, FMEA, 8D, CAPA, SPC, etc.)
* Good knowledge of MS-Office and SAP MM/QM
We have amazing benefits to support you as an employee at ZEISS!
* Medical
* Vision
* Dental
* 401k Matching
* Employee Assistance Programs
* Vacation and sick pay
* The list goes on!
This job description does not state nor imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by management and will also be required to meet safety-related requirements. All requirements are subject to possible modification to reasonably accommodate individuals with a disability.
The hourly pay for this position is $33.00 - $41.00.
The pay offered for this role may be influenced by factors such as job location, scope of role, qualifications, education, experience, & complexity/specialization/scarcity of talent.
This position is eligible for a Performance Bonus.
ZEISS is an EEO/AA/M/F/Disabled Veteran Employer
Your ZEISS Recruiting Team:
Jo Anne Mittelman
Zeiss provides Equal Employment Opportunity without unlawful regard to an Applicants race, color, religion, creed, sex, gender, marital status, age, national origin or ancestry, physical or mental disability, medical condition, military or veteran status, citizen status, sexual orientation, pregnancy (includes childbirth, breastfeeding or related medical condition), genetic predisposition, carrier status, gender expression or identity, including transgender identity, or any other class or characteristic protected by federal, state, or local law of the employee (or the people with whom the employee associates, including relatives and friends).
$33-41 hourly Auto-Apply 37d ago
Quality Specialist - Supplier Assurance Devices
Zeissgroup
Quality assurance specialist job in Dublin, CA
About Us:
How many companies can say they've been in business for over 179 years?!
Here at ZEISS, we certainly can! As the pioneers of science, ZEISS handles the everchanging environments in a fast-paced world, meeting it with cutting edge of technologies and continuous advancements. ZEISS believes that innovation and technology are the key to a sustainable future and solutions for global change. We have a diverse range of portfolios throughout the ZEISS family in segments like, Industrial Quality & Research, Medical Technology, Consumer Markets and Semiconductor Manufacturing Technology. We are a global company with over 42,000 employees and have over 4,000 in the US and Canada alone! Make a difference, come join the team!
Location/Region: This position is located in Dublin, CA
What's the role?
As a Supplier Quality AssuranceSpecialist, you will play a critical role in ensuring the quality and reliability of products sourced from external suppliers. Your primary responsibility will be to implement and maintain robust quality assurance processes across the supply chain to mitigate risks, drive continuous improvement, and up-hold the highest standards of product quality. You will work closely with suppliers, internal stakeholders, and cross-functional teams to evaluate supplier capabilities, assess quality performance, and drive corrective actions where necessary. Your expertise will directly impact on the safety, reliability and efficacy of the medical devices we produce and help us meet regulatory requirements and industry standards. Your expertise will directly impact on the safety, reliability and efficacy of the medical devices we produce and help us meet regulatory requirements and industry standards.
Sound Interesting?
Here's what you'll do:
Quality Compliance
Ensure that all incoming goods adhere to relevant regulatory requirements, industry standards, and the company's quality management system
Ensure that all supplier complaints are managed in compliance with relevant regulations, industry standards and company procedures
Ensure that the records generated in incoming goods inspection and complaints management are detailed, comprehensible, up-to-date and are archived according to specified requirements.
Responsible for maintaining the infrastructure within the SQA department (e.g. administration and release of test equipment, that valid inspection instructions are used, contributing to the validation of processes/methods, etc.)
Responsible for representing supplier quality processes in internal and third-party audits
Participation in supplier audits as Expert or Co. Auditor, Lead of audit scopes
Quality Control (Incoming Inspections)
Responsible for the implementation, execution and improvement of incoming inspection and first article inspection activities
Maintain records of inspection results, document and report any discrepancies, defects or non-conformities identified during inspections
Initiates follow up actions in case of non-conformities in coordination with other departments and/or suppliers
Maintain and communicate KPI's from incoming goods inspection and take actions as needed
Managing Supplier Non-Conformities
Responsible for the implementation, execution and improvement of non-conforming material management activities related to suppliers
Maintain detailed and accurate records of all supplier complaints, investigations, and resolutions in the complaints management system.
Work closely with internal teams and suppliers to address quality issues, drive root cause analyses, and ensure timely and effective corrective and preventive actions (e.g. in LCM, Change Controls, CAPAs,…)
Maintain open and transparent communication with suppliers throughout the complaint handling process
Maintain and communicate KPI's from supplier complaints and take actions as needed
Increase Supplier Performance
Responsible for the quality performance of assigned suppliers
Monitor and assess supplier performance regularly, identifying areas for improvement and implementing necessary corrective and preventive actions when deviations occur
Maintain accurate and up-to-date supplier quality records and documentation
Identify opportunities for process improvements to enhance the efficiency and effectiveness of Supplier Quality Processes and implement process improvements.
Do you qualify?
Bachelor of /Engineering/Science or comparable, required
Minimum 5 years work experience in quality assurance or related roles in quality
Minimum 5 years in complaint handling
Extensive knowledge in quality assurance, complaint handling or supplier management, preferably in the medical devices industry
Analytical mindset with the ability to identify trends and implement data-driven decisions
Expert in interpretation of technical drawing (GD&T) and AQL sampling plan
Experience in modern manufacturing technologies in the fields of mechanics/optics/electronics
Familiarity with measurement tools and equipment used in quality inspection (e.g., calipers, micrometers, 3D CMM, preferably Zeiss Calypso)
Experience on PCBA inspections certified on IPC-A- 610 Standard for Visual acceptability of electronic assemblies
Advanced knowledge of quality assurance and quality management systems, ISO 13485 and ISO 9001. Knowing MDR + FDA requirements is an advantage
Understanding of MSA, GR&R studies, Gage Repeatability and Reproducibility
Excellent communication skills, both written and verbal, to effectively communicate with internal teams and suppliers
Several years of experience in the application of methods and tools in quality management (such as SIX SIGMA, FMEA, 8D, CAPA, SPC, etc.)
Good knowledge of MS-Office and SAP MM/QM
We have amazing benefits to support you as an employee at ZEISS!
Medical
Vision
Dental
401k Matching
Employee Assistance Programs
Vacation and sick pay
The list goes on!
This job description does not state nor imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by management and will also be required to meet safety-related requirements. All requirements are subject to possible modification to reasonably accommodate individuals with a disability.
The hourly pay for this position is $33.00 - $41.00.
The pay offered for this role may be influenced by factors such as job location, scope of role, qualifications, education, experience, & complexity/specialization/scarcity of talent.
This position is eligible for a Performance Bonus.
ZEISS is an EEO/AA/M/F/Disabled Veteran Employer
Your ZEISS Recruiting Team:
Jo Anne Mittelman
Zeiss provides Equal Employment Opportunity without unlawful regard to an Applicants race, color, religion, creed, sex, gender, marital status, age, national origin or ancestry, physical or mental disability, medical condition, military or veteran status, citizen status, sexual orientation, pregnancy (includes childbirth, breastfeeding or related medical condition), genetic predisposition, carrier status, gender expression or identity, including transgender identity, or any other class or characteristic protected by federal, state, or local law of the employee (or the people with whom the employee associates, including relatives and friends).
$33-41 hourly Auto-Apply 39d ago
Quality Specialist - Supplier Assurance Devices
Zeiss
Quality assurance specialist job in Dublin, CA
About Us:
How many companies can say they've been in business for over 179 years?!
Here at ZEISS, we certainly can! As the pioneers of science, ZEISS handles the everchanging environments in a fast-paced world, meeting it with cutting edge of technologies and continuous advancements. ZEISS believes that innovation and technology are the key to a sustainable future and solutions for global change. We have a diverse range of portfolios throughout the ZEISS family in segments like, Industrial Quality & Research, Medical Technology, Consumer Markets and Semiconductor Manufacturing Technology. We are a global company with over 42,000 employees and have over 4,000 in the US and Canada alone! Make a difference, come join the team!
Location/Region: This position is located in Dublin, CA
What's the role?
As a Supplier Quality AssuranceSpecialist, you will play a critical role in ensuring the quality and reliability of products sourced from external suppliers. Your primary responsibility will be to implement and maintain robust quality assurance processes across the supply chain to mitigate risks, drive continuous improvement, and up-hold the highest standards of product quality. You will work closely with suppliers, internal stakeholders, and cross-functional teams to evaluate supplier capabilities, assess quality performance, and drive corrective actions where necessary. Your expertise will directly impact on the safety, reliability and efficacy of the medical devices we produce and help us meet regulatory requirements and industry standards. Your expertise will directly impact on the safety, reliability and efficacy of the medical devices we produce and help us meet regulatory requirements and industry standards.
Sound Interesting?
Here's what you'll do:
Quality Compliance
Ensure that all incoming goods adhere to relevant regulatory requirements, industry standards, and the company's quality management system
Ensure that all supplier complaints are managed in compliance with relevant regulations, industry standards and company procedures
Ensure that the records generated in incoming goods inspection and complaints management are detailed, comprehensible, up-to-date and are archived according to specified requirements.
Responsible for maintaining the infrastructure within the SQA department (e.g. administration and release of test equipment, that valid inspection instructions are used, contributing to the validation of processes/methods, etc.)
Responsible for representing supplier quality processes in internal and third-party audits
Participation in supplier audits as Expert or Co. Auditor, Lead of audit scopes
Quality Control (Incoming Inspections)
Responsible for the implementation, execution and improvement of incoming inspection and first article inspection activities
Maintain records of inspection results, document and report any discrepancies, defects or non-conformities identified during inspections
Initiates follow up actions in case of non-conformities in coordination with other departments and/or suppliers
Maintain and communicate KPI's from incoming goods inspection and take actions as needed
Managing Supplier Non-Conformities
Responsible for the implementation, execution and improvement of non-conforming material management activities related to suppliers
Maintain detailed and accurate records of all supplier complaints, investigations, and resolutions in the complaints management system.
Work closely with internal teams and suppliers to address quality issues, drive root cause analyses, and ensure timely and effective corrective and preventive actions (e.g. in LCM, Change Controls, CAPAs,…)
Maintain open and transparent communication with suppliers throughout the complaint handling process
Maintain and communicate KPI's from supplier complaints and take actions as needed
Increase Supplier Performance
Responsible for the quality performance of assigned suppliers
Monitor and assess supplier performance regularly, identifying areas for improvement and implementing necessary corrective and preventive actions when deviations occur
Maintain accurate and up-to-date supplier quality records and documentation
Identify opportunities for process improvements to enhance the efficiency and effectiveness of Supplier Quality Processes and implement process improvements.
Do you qualify?
Bachelor of /Engineering/Science or comparable, required
Minimum 5 years work experience in quality assurance or related roles in quality
Minimum 5 years in complaint handling
Extensive knowledge in quality assurance, complaint handling or supplier management, preferably in the medical devices industry
Analytical mindset with the ability to identify trends and implement data-driven decisions
Expert in interpretation of technical drawing (GD&T) and AQL sampling plan
Experience in modern manufacturing technologies in the fields of mechanics/optics/electronics
Familiarity with measurement tools and equipment used in quality inspection (e.g., calipers, micrometers, 3D CMM, preferably Zeiss Calypso)
Experience on PCBA inspections certified on IPC-A- 610 Standard for Visual acceptability of electronic assemblies
Advanced knowledge of quality assurance and quality management systems, ISO 13485 and ISO 9001. Knowing MDR + FDA requirements is an advantage
Understanding of MSA, GR&R studies, Gage Repeatability and Reproducibility
Excellent communication skills, both written and verbal, to effectively communicate with internal teams and suppliers
Several years of experience in the application of methods and tools in quality management (such as SIX SIGMA, FMEA, 8D, CAPA, SPC, etc.)
Good knowledge of MS-Office and SAP MM/QM
We have amazing benefits to support you as an employee at ZEISS!
Medical
Vision
Dental
401k Matching
Employee Assistance Programs
Vacation and sick pay
The list goes on!
This job description does not state nor imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by management and will also be required to meet safety-related requirements. All requirements are subject to possible modification to reasonably accommodate individuals with a disability.
The hourly pay for this position is $33.00 - $41.00.
The pay offered for this role may be influenced by factors such as job location, scope of role, qualifications, education, experience, & complexity/specialization/scarcity of talent.
This position is eligible for a Performance Bonus.
ZEISS is an EEO/AA/M/F/Disabled Veteran Employer
Your ZEISS Recruiting Team:
Jo Anne Mittelman
Zeiss provides Equal Employment Opportunity without unlawful regard to an Applicants race, color, religion, creed, sex, gender, marital status, age, national origin or ancestry, physical or mental disability, medical condition, military or veteran status, citizen status, sexual orientation, pregnancy (includes childbirth, breastfeeding or related medical condition), genetic predisposition, carrier status, gender expression or identity, including transgender identity, or any other class or characteristic protected by federal, state, or local law of the employee (or the people with whom the employee associates, including relatives and friends).
$33-41 hourly Auto-Apply 31d ago
Nursing Quality Assurance Coordinator
Kabafusion Holdings, LLC
Quality assurance specialist job in Pleasanton, CA
Come join an exciting and innovative company that puts the “care” back in healthcare!
At KabaFusion, our patients come from all walks of life and so do we. We hire GREAT people, period! Our culture celebrates and supports the differences that make us unique. Here, it doesn't matter what your role is, your hard work and dedication is not only recognized but celebrated. Join us and find out why this is the place to excel and do your best work.
About Us:
What started as a single pharmacy in 2010 has grown into KabaFusion becoming the largest privately held home infusion company in the country. We have a national network of pharmacies and nursing offices strategically placed to service 40+ states. Couple that with over 30 years of combined experience and it's no wonder why KabaFusion is the industry leader in home infusion.
JOB SUMMARY:
The Nursing Quality Assurance Coordinator is responsible for the overall quality assurance and performance improvement program for the agency/branch. Works with nursing and pharmacy teams in order to assist with and manage various quality assurance responsibilities for the agency/branch. Provides patient teaching as needed for new nursing patients for the agency/branch.
MAJOR DUTIES AND RESPONSIBILITIES:
1. Responsible for agency/branch programs for the improvement of quality and service productivity by performing medical record audits, reviewing nursing documentation and collecting QA data for the agency/branch Performance Improvement (PI) program.
2. Performs data collection activities and related data analysis for agency programs and services.
3. Assists with assessing the agency's compliance to State Regulations for offices that are Licensed or Exempt from Licensure and ACHC accreditation.
4. Assists team with preparation for accreditation and certification surveys. Involves staff at all levels in survey compliance issues.
5. Assists with educational activities related to the quality assurance/performance improvement program for all employees.
6. Coordinates quality improvement/PI teams and maintains documentation of all team activity.
7. Serves as a resource to all staff regarding quality improvement and documentation.
8. Assists with orientation related to documentation and improvement for all new employees.
9. Ensures that all agency quality improvement activities are performed adequately and in a timely manner.
10. Coordinates quarterly reporting functions and writes report summaries.
11. Creates the Plan of Treatment/Plan of Care and faxes, tracks, and follows up on the POT/POC//MD orders/Recerts
12. Monitors documentation submission by nursing staff and follows up on late documents.
13. Uses EMR system reports to track POT recert needs and other reports.
14. Works with Intake team to track and maintain Annual Consent logs using Excel spreadsheets or system generated reports as per office practices. Follows up with nursing staff and patients to obtain Annual Consents.
15. Discharges patients in Computer System as needed and verifies census every week.
16. Performs chart audits for active and discharges patients each quarter.
17. Provides virtual or live initial patient education for new nursing patients either in hospital or at patient home.
18. May perform nursing visits to patients in home as needed to assist with branch patient nursing assignments.
19. Participates in the branch nursing on call rotation as needed.
20. May perform nursing supervisory visits as needed for nursing competency.
21. Other duties as assigned
SKILLS AND ABILITIES:
• Demonstrates initiative and skills in planning and organizing work requiring minimal supervision and is self-directed.
• Demonstrates organizational awareness and commitment
• Observes confidentiality policy at all times
• Observes attendance and attire policies
• Complies with all other related policies, procedures and requests
• Conserves agency resources and reduces the likelihood of safety hazards
• Demonstrates interpersonal understanding and utilizes effective communication skills
• Exhibits behaviors of cooperation
• Maintains professional licensure/certification and attends/completes all agency provided/required in-services to fulfill job requirements.
• Exhibits adaptability, flexibility, self-control and maturity in work and behavior
• Exhibits critical thinking abilities and applies them for continuous improvement of services
• Empowers others by sharing responsibility to encourage a deep sense of commitment and ownership.
• Demonstrates self-confidence and ability to think conceptually in leading and directing others
EDUCATION AND/OR EXPERIENCE:
• Minimum education of a registered nurse or a licensed vocational nurse with active license in state of practice
• Minimum of two years of experience in nursing required
• Minimum of 2 years' experience working in a position performing clinical record audits, developing plan of cares, or performing a QI audit function.
• Maintains a current CPR/BLS certification.
• Maintains a current driver's license in good standing required
• Must be a valid licensed driver with an automobile that is consistently insured in accordance with state and agency requirements and is in good working order.
Knowledge and Abilities:
a. Demonstrates knowledge and skills necessary to provide care to and communicate with patients.
b. Able to assess data reflecting the client's status and interpret the appropriate information needed to identify each client's requirement relative to their age-specific needs.
What we offer:
Competitive compensation
Benefits start on your 1st day of employment
401k w 4% match - no waiting or vesting period
PTO / Floating Holidays / Paid Holidays
Company paid life insurance, short term disability
Employee Assistance programs to help with mental health / wellness
Learning & Development Programs
Perks… includes discounts on travel, cell phone, clothing and more…
Generous employee referral program
To learn more about KabaFusion, please visit our careers page: ***********************************
Join us and find out why this is the place to excel and do your best work.
$61k-96k yearly est. Auto-Apply 12d ago
Nursing Quality Assurance Coordinator
Kabafusion
Quality assurance specialist job in Pleasanton, CA
Come join an exciting and innovative company that puts the “care” back in healthcare!
At KabaFusion, our patients come from all walks of life and so do we. We hire GREAT people, period! Our culture celebrates and supports the differences that make us unique. Here, it doesn't matter what your role is, your hard work and dedication is not only recognized but celebrated. Join us and find out why this is the place to excel and do your best work.
About Us:
What started as a single pharmacy in 2010 has grown into KabaFusion becoming the largest privately held home infusion company in the country. We have a national network of pharmacies and nursing offices strategically placed to service 40+ states. Couple that with over 30 years of combined experience and it's no wonder why KabaFusion is the industry leader in home infusion.
JOB SUMMARY:
The Nursing Quality Assurance Coordinator is responsible for the overall quality assurance and performance improvement program for the agency/branch. Works with nursing and pharmacy teams in order to assist with and manage various quality assurance responsibilities for the agency/branch. Provides patient teaching as needed for new nursing patients for the agency/branch.
MAJOR DUTIES AND RESPONSIBILITIES:
1. Responsible for agency/branch programs for the improvement of quality and service productivity by performing medical record audits, reviewing nursing documentation and collecting QA data for the agency/branch Performance Improvement (PI) program.
2. Performs data collection activities and related data analysis for agency programs and services.
3. Assists with assessing the agency's compliance to State Regulations for offices that are Licensed or Exempt from Licensure and ACHC accreditation.
4. Assists team with preparation for accreditation and certification surveys. Involves staff at all levels in survey compliance issues.
5. Assists with educational activities related to the quality assurance/performance improvement program for all employees.
6. Coordinates quality improvement/PI teams and maintains documentation of all team activity.
7. Serves as a resource to all staff regarding quality improvement and documentation.
8. Assists with orientation related to documentation and improvement for all new employees.
9. Ensures that all agency quality improvement activities are performed adequately and in a timely manner.
10. Coordinates quarterly reporting functions and writes report summaries.
11. Creates the Plan of Treatment/Plan of Care and faxes, tracks, and follows up on the POT/POC//MD orders/Recerts
12. Monitors documentation submission by nursing staff and follows up on late documents.
13. Uses EMR system reports to track POT recert needs and other reports.
14. Works with Intake team to track and maintain Annual Consent logs using Excel spreadsheets or system generated reports as per office practices. Follows up with nursing staff and patients to obtain Annual Consents.
15. Discharges patients in Computer System as needed and verifies census every week.
16. Performs chart audits for active and discharges patients each quarter.
17. Provides virtual or live initial patient education for new nursing patients either in hospital or at patient home.
18. May perform nursing visits to patients in home as needed to assist with branch patient nursing assignments.
19. Participates in the branch nursing on call rotation as needed.
20. May perform nursing supervisory visits as needed for nursing competency.
21. Other duties as assigned
SKILLS AND ABILITIES:
• Demonstrates initiative and skills in planning and organizing work requiring minimal supervision and is self-directed.
• Demonstrates organizational awareness and commitment
• Observes confidentiality policy at all times
• Observes attendance and attire policies
• Complies with all other related policies, procedures and requests
• Conserves agency resources and reduces the likelihood of safety hazards
• Demonstrates interpersonal understanding and utilizes effective communication skills
• Exhibits behaviors of cooperation
• Maintains professional licensure/certification and attends/completes all agency provided/required in-services to fulfill job requirements.
• Exhibits adaptability, flexibility, self-control and maturity in work and behavior
• Exhibits critical thinking abilities and applies them for continuous improvement of services
• Empowers others by sharing responsibility to encourage a deep sense of commitment and ownership.
• Demonstrates self-confidence and ability to think conceptually in leading and directing others
EDUCATION AND/OR EXPERIENCE:
• Minimum education of a registered nurse or a licensed vocational nurse with active license in state of practice
• Minimum of two years of experience in nursing required
• Minimum of 2 years' experience working in a position performing clinical record audits, developing plan of cares, or performing a QI audit function.
• Maintains a current CPR/BLS certification.
• Maintains a current driver's license in good standing required
• Must be a valid licensed driver with an automobile that is consistently insured in accordance with state and agency requirements and is in good working order.
Knowledge and Abilities:
a. Demonstrates knowledge and skills necessary to provide care to and communicate with patients.
b. Able to assess data reflecting the client's status and interpret the appropriate information needed to identify each client's requirement relative to their age-specific needs.
What we offer:
Competitive compensation
Benefits start on your 1st day of employment
401k w 4% match - no waiting or vesting period
PTO / Floating Holidays / Paid Holidays
Company paid life insurance, short term disability
Employee Assistance programs to help with mental health / wellness
Learning & Development Programs
Perks… includes discounts on travel, cell phone, clothing and more…
Generous employee referral program
To learn more about KabaFusion, please visit our careers page: ***********************************
Join us and find out why this is the place to excel and do your best work.
$61k-96k yearly est. Auto-Apply 12d ago
Associate - Quality Assurance - Deviation Mentor
Eli Lilly and Company 4.6
Quality assurance specialist job in Concord, CA
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
The Deviation Mentor is a key member of the Quality Assurance (QA) team, responsible for teaching, mentoring, and guiding deviation and laboratory investigations. This role oversees the training program related to deviation investigations, participates in deviation assessments (pre-approval and post-approval), and may lead complex investigations. The Deviation Mentor also collaborates in regulatory inspections, site inspection readiness, and issue resolution. In addition, this role will serve as the site steward for One Quality Management System (One QMS) during the project phase.
Key Responsibilities:
Deviation Investigation & Guidance
* Provide expert guidance to lead investigators on deviation investigations, including root cause analysis, quality impact evaluations, and technical writing.
* Assist and advise deviation reviewers and approvers on issue investigation matters.
* Lead complex investigations and act as a technical reviewer for deviations and analytical investigations.
* Lead or participate in deviation review boards, ensuring thorough pre-approval and post-approval reviews.
* Support the development and review of deviation trend reports.
* Design and deliver training programs related to deviations and investigations.
* Develop site-specific deviation and investigation metrics.
One QMS Responsibilities
* Manage the transition of the Quality Management System (QMS) from TrackWise to Veeva for the Concord site.
* Collaborate with the global QMS I3 team to align site deliverables and timelines.
* Present progress reports on QMS I3 implementation to site leadership, including key actions and timelines.
* Act as the Power User and Site Instructor for the QMS I3 Veeva system, covering deviations, change controls, and CAPA.
* Author and review documentation as a Subject Matter Expert for the Concord site's QMS I3 implementation.
Qualifications:
* Bachelor's or Master's degree in a scientific or technical field (e.g., chemistry, biology, microbiology, engineering).
* 5+ years of experience in pharmaceutical manufacturing operations with preference for parenteral manufacturing
* Strong technical writing, critical thinking, and organizational skills.
* Exceptional communication and interpersonal skills, with a proven ability to provide constructive, actionable feedback to enhance technical document clarity and quality.
* Demonstrated talent for fostering a collaborative environment where open dialogue and positive critique drive continuous improvement in deviation writing practices.
* Good knowledge of cGMP, regulatory standards, and quality system requirements.
Preferred Attributes:
* 7+ years in QA roles within the pharmaceutical or medical device industry.
* Experience with GMP systems, including Deviation Management and Document Control systems.
* Advanced technical proficiency in deviation management, CAPA, change control, and product complaint handling.
* Regulatory inspection experience, including readiness and execution
* Familiarity with TrackWise, Veeva, and parenteral product materials.
* Proven ability to lead global or local project implementations and influence cross-functional teams.
Other Information:
* Occasional off-hours or weekend support for 24/7 manufacturing operations.
* Travel: Up to 10%.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$63,000 - $162,800
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
$63k-162.8k yearly Auto-Apply 5d ago
PT Quality Assurance Associate
Ahold Delhaize
Quality assurance specialist job in Antioch, CA
DUTIES AND RESPONSIBILITIES • Maintain an atmosphere of enthusiastic customer awareness with primary emphasis on fast, friendly, and accurate customer service to create a positive shopping experience • Courteous and helpful to other associates • Sweep and clean floors on nights with no scheduled vendor services
• Weekly cleaning of Produce, Market and Deli Departments
• Clean and organize the store mop room
• Find more efficient ways to do the job and seek to reduce costs and improve labor productivity
• Follow QA daily check list and sanitation standards set by Food Lion
• Follow current Standard Practices regarding cleanup of Hazardous Waste product
• Maintain a complete understanding of and adherence to company guidelines, policies and standard practice
• Understand and follow Food Safety and Workplace Safety guidelines and procedures
• Observe and correct all unsafe conditions that could cause associate or customer accidents
• Report all associate and customer accidents in accordance with established Food Lion procedures to the Manager on Duty
• Ensure compliance with local, state and federal regulations
• Wear the Food Lion uniform complete with name badge, when on duty, has a neat and clean appearance while adhering to the Food Lion dress code
• Successfully complete Computer Based Training (CBT), Training Packet and Training Aid courses
• Perform all other duties as assigned
QUALIFICATIONS
• High school graduate or equivalent preferred
• Excellent interpersonal, organizational, communication and customer service skills
• Ability and willingness to learn multiple tasks and technical requirements of the job
• Ability to use technical information to solve problems
• Must meet minimum age requirements to perform specific job functions
• Must be able to meet the physical requirements of the position, with or without reasonable accommodations"
PHYSICAL REQUIREMENTS
• Ability to use computers and other communication systems required to perform job functions
• Perform repetitive hand and arm motions
• Bend and lift products weighing up to 15 lbs. continuously, 25 lbs. frequently, and 50 lbs. on occasion
• Pull or push up to 75 lbs. on occasion"
• Stand 100% of the time, frequently walking short distances
• Be able to handle a variety of substances associated with cleaning and packaging materials, fresh fruits, vegetables, house plants/flowers and household cleaners
• Use hands to frequently/continuously handle currency (paper and coin) as well as operate a variety of equipment such as cash register, lottery machine (where applicable), scanner, computer, and calculator
• Frequent reaching and grasping at waist level: occasionally above shoulder or below waist level
• Meet established volume activity standards for the position
• Tolerate working in extreme hot/cold temperatures for up to 20 minutes at a time
• Have sufficient visual ability to check ID cards, checks, invoices and other written documents"
Food Lion provides equal employment opportunities to all associates and applicants for employment without regard to race, color, religion, sex (including pregnancy, childbirth and related conditions) national origin, age, disability, sexual orientation, veteran status, gender identity or gender expression or any other characteristic protected by law.
$50k-78k yearly est. 30d ago
Documentation Specialist-Photonics
Gooch and Housego
Quality assurance specialist job in Fremont, CA
We are seeking a Documentation Specialist to join our team in Fremont, CA, supporting the photonics industry's cutting-edge manufacturing processes. This role is essential in ensuring that our manufacturing processes are accurately documented and in compliance with industry standards. The ideal candidate will have experience in technical writing, process documentation, and a strong understanding of manufacturing or photonics-related workflows.
Key Responsibilities:
* Develop, organize, and maintain comprehensive documentation for manufacturing processes, including standard operating procedures (SOPs), work instructions, and process workflows.
* Collaborate with cross-functional teams, including engineers, production staff, and quality assurance, to gather technical information and ensure accuracy.
* Translate complex technical information into clear, concise, and user-friendly documents.
* Ensure all documentation adheres to company standards, industry regulations, and ISO or other relevant quality management requirements.
* Assist in implementing and maintaining document control systems to manage revisions and updates effectively.
* Conduct regular reviews and audits of existing documentation to ensure currency and accuracy.
* Train and support staff in understanding and using documentation as needed.
* Work closely with the manufacturing team to identify process improvements and reflect updates in documentation.
Requirements
* Bachelor's degree in a relevant field (e.g., Engineering, Technical Writing, or related discipline).
* 2+ years of experience in technical documentation, preferably in manufacturing or the photonics industry.
* Familiarity with photonics manufacturing processes and terminology is highly desirable.
* Strong technical writing and editing skills, with the ability to convey complex information clearly.
* Proficiency in documentation tools (e.g., Microsoft Office Suite, Adobe Acrobat, or specialized tools like Visio).
* Experience with document control systems and compliance standards such as ISO 9001 or similar.
* Excellent organizational skills and attention to detail.
* Ability to work collaboratively in a fast-paced environment.
* Strong analytical and problem-solving skills.
Preferred Skills:
* Knowledge of photonics technologies and optical systems.
* Familiarity with Lean, Six Sigma, or other process improvement methodologies.
* Experience in training staff on documentation and processes.
What We Offer:
* Competitive salary and benefits package.
* Opportunity to work in a dynamic, innovative industry.
* Career growth and development opportunities.
* Collaborative and supportive work environment.
Note: This is not intended to be exhaustive in every respect, but rather to clearly define the fundamental purpose, responsibilities and dimensions for the role. Therefore, this does not describe any individual role holder. In addition to the contents of this job description, employees are expected to undertake all other reasonable and related tasks allocated by their line manager.
The Company is committed to providing equal employment opportunities for all employees and applicants for employment. The Company does not discriminate in employment opportunity or practices on the grounds of gender, race, religion or belief, age, disability, sexual orientation, gender identity, protected veteran status, or any other characteristic protected by national laws under which the Company operates.
In the instance that the position will involve having access to items and technical data that may be controlled under U.S. export laws and regulations ("U.S. Export Control Laws"), including but not limited to the Export Administration Regulations ("EAR") and the International Traffic in Arms Regulations ("ITAR"). To comply with the U.S. Export Control Laws, and in conjunction with the review of candidates for those positions within G&H that may present access to export-controlled technical data, G&H must assess whether candidates are "U.S. persons" as defined under the EAR (15 C.F.R. Part 772) and the ITAR (22 C.F.R. § 120.15). Certain questions asked during the application process are intended to assess this and will be used for evaluation purposes only. Failure to provide the necessary information in this regard will result in our inability to consider you further for this position.
Salary Description
$75-85K annually
$75k-85k yearly 20d ago
Documentation Specialist-Photonics
Gooch & Housego PLC
Quality assurance specialist job in Fremont, CA
Description:
We are seeking a Documentation Specialist to join our team in Fremont, CA, supporting the photonics industry's cutting-edge manufacturing processes. This role is essential in ensuring that our manufacturing processes are accurately documented and in compliance with industry standards. The ideal candidate will have experience in technical writing, process documentation, and a strong understanding of manufacturing or photonics-related workflows.
Key Responsibilities:
Develop, organize, and maintain comprehensive documentation for manufacturing processes, including standard operating procedures (SOPs), work instructions, and process workflows.
Collaborate with cross-functional teams, including engineers, production staff, and quality assurance, to gather technical information and ensure accuracy.
Translate complex technical information into clear, concise, and user-friendly documents.
Ensure all documentation adheres to company standards, industry regulations, and ISO or other relevant quality management requirements.
Assist in implementing and maintaining document control systems to manage revisions and updates effectively.
Conduct regular reviews and audits of existing documentation to ensure currency and accuracy.
Train and support staff in understanding and using documentation as needed.
Work closely with the manufacturing team to identify process improvements and reflect updates in documentation.
Requirements:
Bachelor's degree in a relevant field (e.g., Engineering, Technical Writing, or related discipline).
2+ years of experience in technical documentation, preferably in manufacturing or the photonics industry.
Familiarity with photonics manufacturing processes and terminology is highly desirable.
Strong technical writing and editing skills, with the ability to convey complex information clearly.
Proficiency in documentation tools (e.g., Microsoft Office Suite, Adobe Acrobat, or specialized tools like Visio).
Experience with document control systems and compliance standards such as ISO 9001 or similar.
Excellent organizational skills and attention to detail.
Ability to work collaboratively in a fast-paced environment.
Strong analytical and problem-solving skills.
Preferred Skills:
Knowledge of photonics technologies and optical systems.
Familiarity with Lean, Six Sigma, or other process improvement methodologies.
Experience in training staff on documentation and processes.
What We Offer:
Competitive salary and benefits package.
Opportunity to work in a dynamic, innovative industry.
Career growth and development opportunities.
Collaborative and supportive work environment.
Note: This is not intended to be exhaustive in every respect, but rather to clearly define the fundamental purpose, responsibilities and dimensions for the role. Therefore, this does not describe any individual role holder. In addition to the contents of this job description, employees are expected to undertake all other reasonable and related tasks allocated by their line manager.
The Company is committed to providing equal employment opportunities for all employees and applicants for employment. The Company does not discriminate in employment opportunity or practices on the grounds of gender, race, religion or belief, age, disability, sexual orientation, gender identity, protected veteran status, or any other characteristic protected by national laws under which the Company operates.
In the instance that the position will involve having access to items and technical data that may be controlled under U.S. export laws and regulations ("U.S. Export Control Laws"), including but not limited to the Export Administration Regulations ("EAR") and the International Traffic in Arms Regulations ("ITAR"). To comply with the U.S. Export Control Laws, and in conjunction with the review of candidates for those positions within G&H that may present access to export-controlled technical data, G&H must assess whether candidates are "U.S. persons" as defined under the EAR (15 C.F.R. Part 772) and the ITAR (22 C.F.R. § 120.15). Certain questions asked during the application process are intended to assess this and will be used for evaluation purposes only. Failure to provide the necessary information in this regard will result in our inability to consider you further for this position.
$42k-69k yearly est. 20d ago
QA Associate
Asahi Kasei 4.3
Quality assurance specialist job in Fremont, CA
The Asahi Kasei Group operates with a commitment of creating for tomorrow. Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems. Because our success depends on our ability to exceed our clients' expectations, we look for candidates with an innate desire to serve. Adaptability and an interest in transformative action are also common attributes among our team. Bionova became a subsidiary of Asahi Kasei Medical in May 2022, a division of Tokyo-based Asahi Kasei Group. This acquisition has enabled Bionova to greatly accelerate growth of the business, both in capacity of current service offerings and expansion into new service offerings.
Company:
Bionova Scientific LLC
Job Description:
Company Summary:
Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems.
Because our success depends on our ability to exceed our clients' expectations, we look for candidates with an innate desire to serve. Adaptability and an interest in transformative action are also common attributes among our team.
Position Summary:
Bionova is seeking a motivated and innovative QA Associate to join the Quality Assurance department to contribute to our expanding business.
This position will work independently to provide quality assurance oversight activities of any assigned operations department to ensure adherence to cGMP's, regulatory, industry, and Bionova requirements including manufacturing, batch record review, batch disposition, new product introduction/product transfer, external quality and quality control, critical utilities, (e.g., WFI, Steam, Automation, equipment, HVAC, etc.) and warehouse.
Essential Duties and Responsibilities:
Technical acumen and management of electronic quality systems (e.g. Master Control document coordination and control activities).
Ensures Quality decisions are made, with consultation from Quality colleagues, which may have a direct impact on active manufacturing operations, the release of equipment, systems, or areas.
Provides guidance to MFG, Facilities and Engineering, and/or QC to ensure compliance with all applicable regulations and assists in resolution of issues identified.
Identifies, classifies and reports deviations, as appropriate and typically works on Minor, less complex deviations.
Ensures timely closure of deviations and oversees execution of remediation/CAPA activities required to continue production or move a process to the next milestone.
Works closely with cross functional team members to determine root cause and potential preventative/corrective actions.
Is required to escalate critical issues within area assigned to senior management team based on severity of the issue.
Provides continuous improvement ideas in the assigned area to recognize opportunities for improvement and drive change throughout the organization
Participates in inspection readiness activities and is involved in inspections by Regulatory Agencies
May perform other duties as assigned.
Working Conditions:
This position requires you to work primarily in an office setting, while also supporting oversight activities in Manufacturing, QC and the Warehouse. (cleanroom environments such manufacturing require appropriate gowning).
Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet, and body.
Must be able to lift, push, and carry up to 10 lbs.
Qualifications:
Associate's degree and/or 2+ years of related experience
Requires 0-2 years of pharmaceutical or life-sciences experience.
Experience with electronic quality systems is a plus (e.g. Master Control, Veeva, etc.).
Must possess excellent verbal and written communication skills; good interpersonal skills.
Ability to handle multiple tasks concurrently and complete tasks in a timely manner.
Strong independent judgment and decision-making abilities and strong conflict resolution required.
Demonstrates initiative; ability to undertake additional responsibilities and respond to situations as they arise with little supervision.
Proficiency in Microsoft Office including Word, Excel, PowerPoint.
Ability to make independent sound decisions and manage priorities in alignment with department and site drivers.
Compensation Range: The base compensation range for this role is between $30 and $35 an hour. However, the actual compensation may vary depending on your experience and qualifications.
Health Benefits and Program: Bionova offers health benefits at a subsidized rate.
Healthcare, Dental, and Vision insurance
Life Insurance and Disability Program: 100% covered by Bionova.
Retirement Plan (401K) Up to 8% of Employer Match
Paid time off up to two weeks
10 days of Holidays and 5 days of Sick Leave.
As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.
$30-35 hourly Auto-Apply 60d+ ago
Documentation Specialist
Industrial Electric Manufacturing 4.1
Quality assurance specialist job in Fremont, CA
About IEM
Industrial Electric Mfg. (IEM) is the largest independent full-line manufacturer of custom power distribution systems in North America. Founded more than 75 years ago in Fremont, California, IEM grew alongside Silicon Valley and today operates over 1.7 million square feet of manufacturing capacity. With $1B+ in annual sales and 10,000+ commissioned projects across technology, data centers, commercial, energy, utilities, healthcare, industrial, and infrastructure markets, IEM continues to deliver exceptional product quality, dependable service, and the flexibility to meet complex technical requirements at scale.
Documentation Specialist
Location: Fremont, CA
Reports To: Technical Program Manager
Salary Range: $99,000 - $124,000 Annually
Position Summary
This is a diverse role and your ability to build effective, collaborative relationships with internal and external stakeholders is essential to understanding and supporting the complexities of this rapidly growing program.
As Documentation Specialist reporting to the Technical Program Manager, you will be responsible for, but not limited to, the following for our key enterprise client:
Key Responsibilities
Manage and track customer engineering submittals and O&M including:
Responsible for the creation and release of product engineering documentation for project specific applications. Work directly with Commercial and Engineering and groups to prepare product submittal packages. This product documentation is the basis of design for product manufactured to the plans and specifications of our Clients.
As-built, QC and field commissioning close-out/record documentation to form the final O&M package and deliver to the entity managing for a given build.
Provide assistance to design engineering professionals in order to ensure accurate design documentation.
Monitor and coordinate the overall timing and flow of both Product Submittal and O&M documentation releases for projects ensuring that schedules are being met.
Ensure that documentation standards and procedures keep pace with current practices and business requirements.
Advise management when changes to documentation standards and procedures are needed and assist in development of new standards and procedures to improve quality and efficiency
Communicate effectively with internal partners and customers and industry contacts (where required), in a timely and professional manner. Ensure all affected departments are well informed and provided with timely updates to open projects/concerns
Meet or exceed customer SLA criteria for documentation, RFI and resubmittals while providing feedback to commercial/engineering teams that will enable continuous improvement.
Qualifications
Bachelor's degree in electrical engineering preferred, or equivalent in relevant experience.
The position requires excellent communications and employee relations skills.
Enthusiasm for learning and growth; proactively identifies opportunities and takes initiative to resolve issues.
Tendency to meet challenges with a problem-solver mindset.
Demonstrated ability to manage concurrent deliverables and work effectively in a dynamic, fast-paced environment.
Proficiency with MS Office 365, Adobe/Bluebeam, AutoCAD, BI software (Tableau, PowerBI) and ERP systems (Infor would be an asset)
Occasional travel outside of Canada is required.
Compensation actually offered for this role will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.
Why Join IEM
At IEM, you'll join a team that powers some of the world's most ambitious projects. We're engineers, makers, and problem-solvers who thrive on tackling complex challenges and delivering solutions that keep industries moving forward. If you're driven, collaborative, and ready to make an impact, we'd love to hear from you. Your creativity and passion can help us achieve great things-come be part of the journey.
Learn more about IEM at *********************
We offer comprehensive and competitive benefits package designed to support our employees' well-being, growth, and long-term success. View a snapshot of our benefits at *********************/careers
Recruiting Scams
Beware of recruiting scams. IEM never charges candidates fees, and all recruiter emails come from ************* address. If you suspect fraudulent activity, do not share personal information and report it to us at iemfg.com/contact
Non-Discrimination Statement
IEM does not discriminate against any applicant based on any characteristic protected by law.
Privacy
Information collected and processed as part of your IEM Careers profile, and any job applications you choose to submit is subject to IEM's Workforce Member Privacy Policy.
$40k-54k yearly est. Auto-Apply 39d ago
Quality Systems Analyst
Supermicro 4.7
Quality assurance specialist job in San Jose, CA
Supermicro is a Top Tier provider of advanced server, storage, and networking solutions for Data Center, Cloud Computing, Enterprise IT, Hadoop/ Big Data, Hyperscale, HPC and IoT/Embedded customers worldwide. We are the #5 fastest growing company among the Silicon Valley Top 50 technology firms. Our unprecedented global expansion has provided us with the opportunity to offer a large number of new positions to the technology community. We seek talented, passionate, and committed engineers, technologists, and business leaders to join us.
Job Summary:
This position works directly with multiple teams to support the development and implementation of a proactive Quality Management System (QMS), Environmental Management System (EMS), and Information Security Management System (ISMS). This includes the creation, training, deployment, auditing, and maintenance of the global Supermicro Quality and Environmental Managements Systems. Modify, update, and maintain records and documentation pertaining to site certification under ISO 9001 / 13485 / 14001 / 27001.
The Quality Systems Analyst will be responsible for the local site's QMS, EMS, ISMS and other related management systems.
Essential Duties and Responsibilities:
Support the implementation, maintenance and improvement of the QMS, EMS, ISM, procedures and department specific processes.
Plan, perform, assist in company-wide internal audit program, from planning, implementation, report generation, corrective action issuance, verification and closure.
Support external audits by the Notified Body, other regulatory bodies and third-party auditors.
Day-to-day management of the local ISO related activities and projects, including but not limited to the following;
Work closely with all departments in regard to ISO implementation, issues, maintenance and improvement activities;
Coordinate appropriate and effective corrective and preventive (CAPA) actions in response to pertinent observations and findings from the audit program, external regulatory agency inspections, customer complaints and other internal / external non-conformances.
Document Control activities through the automated documentation system including training of associates to read, review and approve documents; and maintaining a fully compliant system;
Detailed review of ISO controlled documents in order to ensure its adequacy;
Assists in the gathering, trending and reporting of performance indicators and reporting the status to management;
Serve as the process owner and subject matter expert for key elements of the QMS, EMS, ISM, including CAPA, Complaint Handling and Internal Audit.
Support the development of requirements, validation and implementation of automation projects to optimize the effectiveness of the QMS, EMS and ISM.
Execute and complete projects and other duties as assigned.
Qualifications:
Bachelor's degree in related field required and minimum 2 years of relevant experience in quality system with experience in manufacturing and / or high-tech industry preferred
Experience in developing and leading quality and environmental management system audits in the semiconductor / electronics manufacturing, pharmaceutical or medical device industries.
Working knowledge of ISO International Standards, such as ISO 9001, 13485, 14001, 27001, AS9100, TS16949, etc.
Influence management skills; demonstrated ability to work constructively across all functions of the organization, including with customers and suppliers.
Strong communication and presentations skills (articulate and persuasive).
Sound organizational and multi-tasking skills.
Strong computer and analytical skills, including data analysis and reporting using, Microsoft Excel, Access, Word, PowerPoint, Outlook, etc.
Knowledge of Risk Management (risk assessment tools such as FMEA, fault tree, etc.) and KPI (Key Process indicators).
Fast-paced office environment; requires significant use of telephone and computer keyboard, monitor, and mouse.
May require domestic and international travel (10-20%).
This is a temp to hire position.
Salary Range
$68,640 - $74,000
The salary offered will depend on several factors, including your location, level, education, training, specific skills, years of experience, and comparison to other employees already in this role. In addition to a comprehensive benefits package, candidates may be eligible for other forms of compensation, such as participation in bonus and equity award programs.
EEO Statement
Supermicro is an Equal Opportunity Employer and embraces diversity in our employee population. It is the policy of Supermicro to provide equal opportunity to all qualified applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status or special disabled veteran, marital status, pregnancy, genetic information, or any other legally protected status.
$68.6k-74k yearly 2d ago
PT Quality Assurance Associate
Ahold Delhaize
Quality assurance specialist job in Concord, CA
Count on Me - We know what to do, we make it easy, we do our part and we care!
Job Title: FT/PT Quality Assurance Associate
Success Factors Job Code: 1300594
Department: Center Store (Grocery)
Reports To: Assistant Store Manager
Where Applicable: Evening Manager
Primary Purpose:
Provide our customers with a clean, safe, inviting place to shop by maintaining standards in accordance with the standard practice manual. Minimize shrink through proper utilization of standard practice.
Duties and Responsibilities:
Maintain an atmosphere of enthusiastic customer awareness with primary emphasis on fast, friendly, and accurate customer service to create a positive shopping experience
Courteous and helpful to other associates
Sweep and clean floors on nights with no scheduled vendor services
Weekly cleaning of Produce, Market and Deli Departments
Clean and organize the store mop room
Find more efficient ways to do the job and seek to reduce costs and improve labor productivity
Follow QA daily check list and sanitation standards set by Food Lion
Follow current Standard Practices regarding cleanup of Hazardous Waste product
Maintain a complete understanding of and adherence to company guidelines, policies and standard practice
Understand and follow Food Safety and Workplace Safety guidelines and procedures
Observe and correct all unsafe conditions that could cause associate or customer accidents
Report all associate and customer accidents in accordance with established Food Lion procedures to the Manager on Duty
Ensure compliance with local, state and federal regulations
Wear the Food Lion uniform complete with name badge, when on duty, has a neat and clean appearance while adhering to the Food Lion dress code
Successfully complete Computer Based Training (CBT), Training Packet and Training Aid courses
Perform all other duties as assigned
Qualifications:
High school graduate or equivalent preferred
Excellent interpersonal, organizational, communication and customer service skills
Ability and willingness to learn multiple tasks and technical requirements of the job
Ability to use technical information to solve problems
Must meet minimum age requirements to perform specific job functions
Must be able to meet the physical requirements of the position, with or without reasonable accommodations
Physical Requirements:
Ability to use computers and other communication systems required to perform job functions
Perform repetitive hand and arm motions
Bend and lift products weighing up to 15 lbs. continuously, 25 lbs. frequently, and 50 lbs. on occasion
Pull or push up to 75 lbs. on occasion
Stand 100% of the time, frequently walking short distances
Be able to handle a variety of substances associated with cleaning and packaging materials, fresh fruits, vegetables, house plants/flowers and household cleaners
Use hands to frequently/continuously handle currency (paper and coin) as well as operate a variety of equipment such as cash register, lottery machine (where applicable), scanner, computer, and calculator
Frequent reaching and grasping at waist level: occasionally above shoulder or below waist level
Meet established volume activity standards for the position
Tolerate working in extreme hot/cold temperatures for up to 20 minutes at a time
Have sufficient visual ability to check ID cards, checks, invoices and other written documents
08/24/2021: Change in job code from 131/132 to SF job code 1300594
$50k-78k yearly est. 60d+ ago
Learn more about quality assurance specialist jobs
How much does a quality assurance specialist earn in Manteca, CA?
The average quality assurance specialist in Manteca, CA earns between $51,000 and $130,000 annually. This compares to the national average quality assurance specialist range of $41,000 to $97,000.
Average quality assurance specialist salary in Manteca, CA