Post job

Quality assurance specialist jobs in Novato, CA

- 403 jobs
All
Quality Assurance Specialist
Quality Assurance Associate
Document Specialist
Quality Assurance Coordinator
Senior Quality Assurance Manager
Senior Specialist Quality Assurance
Quality Assurance Manager
Senior Quality Assurance Engineer
Quality Systems Specialist
  • Sr. QA Engineer with Strong retail domain Experience

    Nexify Infosystems

    Quality assurance specialist job in Dublin, CA

    Title : Sr. QA Engineer with Strong retail domain Experience Duration : 12+ Months Retail Domain is Must Mandatory: Strong retail domain knowledge, particularly in Promotions (Content Management Tool) Hands-on experience in API Automation Strong in QA testing with 8+ Yrs of experience Should have team handling skills with a minimum of 5+ members of the team Reviewing the customer requirements & preparing the Test Plan Strong manual testing experience in Develop & Execute test cases for new features and ensure the defect-free release of the application Strong automation experience in UiPath Good to have - SQL & Experience in API Automation (Rest Assured) Experience in CI/CD tools like Jenkins Good exposure/experience in Mobile Automation (Android & IOS) Knowledge/exposure in UiPath added advantage Should be proactive, solution provider and good in status reporting. Co-ordinate between onshore/offshore teams, and other support groups for smooth implementation of testing Good in customer Interaction and work independently on his/her own on the daily tasks. Should be very flexible Must have Retail domain knowledge or Experience (Online - Shopping, Sales & Stores)
    $112k-153k yearly est. 2d ago
  • Document Specialist

    Insight Global

    Quality assurance specialist job in San Ramon, CA

    Application Processor L1 Schedule: Monday-Friday, 8-hour shifts between 6:00 AM - 5:00 PM Type: Full-time (40 hours/week) Contract Duration: 1 year with potential extensions Openings: 9 Pay Rate: $25.50/hour Required Qualifications • 6 months to 5 years of administrative, document processing, or data entry/clerical experience • Associate's or Bachelor's degree in IT, Environmental Science/Studies, Renewables, Business Management, Engineering, or similar field • Strong attention to detail • Excellent written and verbal communication skills • Team-oriented mindset • Analytical and problem-solving abilities • Technical proficiency with management systems or software (SAP, Oracle, Salesforce, SmartSheets, customer ERP, etc.) Preferred Qualifications • Experience in utilities, telecom, solar, or renewables industries Position Overview Our client partners with homeowners who are adopting renewable energy solutions (solar, electric vehicles, energy storage systems) to facilitate the storage of customer-generated energy to the electric grid. Our team processes applications for home and small business owners, which includes reviewing applications, building permits, and equipment documentation; ensuring accuracy; identifying issues; submitting defect reports; and forwarding accurate applications to engineering review. Core Responsibilities Application Review • Process customer applications, including review of documentation and verification of accuracy • Send invoices to customers • Submit defect reports or forward applications to engineering review as appropriate • Respond to customer inquiries regarding defects, project status, and delay notices • Analyze project issues and implement solutions to advance projects • Develop documentation such as job aids and process flow charts Engineering Review • Collaborate with Distribution Planning to assess solar installation impacts on the client's network • Follow up with installers based on feedback from Distribution Engineers • Use mapping and reporting tools to evaluate transformer capacity for supporting solar installations • Respond to customer inquiries regarding project status and issues Meter/Variance Review • Work with Metering Engineers and follow up with installers based on engineer feedback • Review solar installation plans and verify interconnection methods shown in technical diagrams • Respond to customer inquiries regarding project status and issues Field Metering Review • Coordinate onsite inspections and meter-related work between installers and internal contacts • Submit field verification requests • Communicate with internal partners about inspection findings to update SAP customer records • Provide follow-up information to installers as needed • Respond to customer inquiries regarding project status and issues
    $25.5 hourly 5d ago
  • QA Specialist I/II

    Artech Information System 4.8company rating

    Quality assurance specialist job in Emeryville, CA

    Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description • The QA Specialist will work as a team member of the Upstream Quality Assurance Production Process Unit to support all aspects of quality related to the manufacture of products. • Primary responsibility is to provide Shop Floor QA support during routine operations in the Manufacturing area • Support Manufacturing activities during scheduled shifts. This will require and include weekend support. • Independently and in some cases, with guidance from senior management, provides quality advice to Manufacturing and Quality groups regarding on-going manufacturing and testing. • Ensures compliance to documents that govern Manufacturing and Quality operations. • Performs an independent quality review of the work performed by Manufacturing and Quality groups. (BPD, TRF, Logbook) • Perform minor deviation investigations and follow up to ensure timely resolution or escalation, if deemed necessary during the process of investigation. • Performs and reviews minor deviation investigations and coordinates with QA team to ensure closure and disposition of impacted products. • Assist with investigations related to suppliers for their designated production area. • Troubleshoot problems in their assigned production process unit, identify and isolate causal factors through effective root cause analysis techniques and proactively innovate new and effective strategies for problem resolution solutions. • May interact with regulatory and partner auditors/inspectors during tours. • Comply Site Environmental Health & Safety (EH&S) requirements Qualifications • Must have \experience in one or more of the main areas listed: • Fermentation processes using E.coli, yeast,cell culture or other organisms • Analytical testing methods such as Lowry, Bradford, BCA, SDS-PAGE, Western Blot, HPLC, Amino Acid Analysis, ELISA's and in vitro diagnostic test kits for the analysis of finished products. • Microbiological methods such as Microbial Limits Test (bioburden), Sterility, Endotoxin, TOC, Microbial Identification, Contamination testing that may impact production processes. • Manufacture of Bacterial and Yeast Seedstocks • Environmental/Utility/facility Monitoring programs and impact to production facilities • Equipment qualification, calibration and preventitive maintenance programs • Experience in one or more validation areas: Process, Cleaning, Facilities, Utilities and Equipment validation • Strong scientific analytical skills, proficient in MS Word, MS PowerPoint and MS Excel software. • Must be familiar with GMP's and Quality System Regulations (QS Regs). • Must have good planning and organizing skills, manage time effectively by prioritizing tasks, taking the initiative to solve problems quickly, and knowing when to obtain assistance. Additional Information Regards, Anuj Mehta ************
    $85k-126k yearly est. 17h ago
  • Sr. QA/QC specialist (F2F Interview) biologics, biotechnology, pharmaceutical or biopharmaceutical experience

    360 It Professionals 3.6company rating

    Quality assurance specialist job in Foster City, CA

    Responsibilities: Experience : 1. Must have a minimum 10 years of relevant experience within Quality or Compliance 2. Must have previous biologics, biotechnology, pharmaceutical or biopharmaceutical experience Additional Information Thanks and Regards, Happy Singh 847 258 9595 Ext:- 408 happy.singh(@)itconnectus.com
    $110k-143k yearly est. 17h ago
  • Quality Assurance Specialist

    Channel Personnel Services

    Quality assurance specialist job in San Francisco, CA

    Job DescriptionManage the development, implementation, and evaluation of the processes that comprise quality management system.Ensure that the quality management system conforms to the requirements of the AS9100 standard.Ensure that the processes established are delivering their intended outputs.Reporting on the performance of the quality management system is maintained when changes to the quality system are planned and implemented.Create, review, and revise Quality Assurance standard operating procedures (SOP'S).Configuration management disciplines, tools, and practices to ensure that products and services meet engineering requirements.Perform closed-looped corrective action and root cause analysis.Ensure compliance of certifications.Responsible for product and data presentation for final customer acceptance.Lead the resolution of non-conforming material issues.Technical writing skills that include quality procedures and test plans.Performs products, process, and system audits and verifies effectiveness or corrective actions that were taken.Must demonstrate the following emotional intelligence skills:Emotional EmpathyPositive AttitudeExcellent Communication SkillsFlexibility / AdaptabilityInterpersonal Skills QUALIFICATIONS / REQUIREMENTSBachelors or better in Chemistry or related field.3-5 years: Aerospace quality assurance experience E04JI800n8pv407n7z4
    $65k-105k yearly est. 10d ago
  • QA/IC Specialist

    Earls Organic Produce 4.1company rating

    Quality assurance specialist job in San Francisco, CA

    Job Description The Quality Assurance Specialist is responsible for ensuring that products meet established standards of quality. ESSENTIAL DUTIES AND RESPONSIBILITIES Maintain strict adherence to Good Handling practices; Coordinate inspection of product- (Incoming and In-House) to ensure high quality standards at all times; Review and appropriately respond to email requests and directives from Purchasing and Sales departments -generated instructions for product handling and conditioning; Stage inventory to sell time-sensitive product on a first-in-first -out basis appropriately process; Conduct daily inventory inspections of 475+ line items of fresh fruits and vegetables; Inspect existing inventory to ensure physical items on-hand match database software's items-on hand; Consistently monitor strategic management of product storage; Review and address condition and ripeness levels of all commodities; Respond to questions from night and morning shift warehouse personnel regarding specific product lot selections for customer's orders; Actively support other Operations Team members; Regularly communicate ideas and concerns to Quality Assurance Supervisor; Ensures work is performed safely at all times; Wear proper safety equipment at all times; Punctuality and regular and reliable attendance. Perform other duties as directed, developed or assigned. SUPERVISORY RESPONSIBILITY Non-applicable. QUALIFICATION REQUIREMENTS Education and/or Experience: Minimum High School degree required. HAACP training preferred. ServSafe certification preferred. Minimum three years hands-on fresh produce experience, retail merchandising, inventory control, sales or product handling role required. Language Skills: Excellent Communication skills including reading, writing, and verbally communicating effectively and professionally with other business departments, customers, and vendors. Ability to diplomatically deal with difficult situations and people while exhibiting a consistent level of professionalism. Technical Skills: Good computer skills including Microsoft Office Suite and Warehouse Inventory software. Reasoning Ability: Ability to think independently and to solve practical problems and deal with a variety of different situations without set guidelines. Ability to interpret a variety of instructions furnished in written, oral, report or schedule form. Equipment: Operate equipment such as, but not limited to, forklift, stand up pallet jack, electric pallet jack, computer, calculator, copier, phone. Other Skills & Abilities: Must be able to work variable hours, days, weekends & Holidays. Ability to multi task and prioritize in a time-pressured environment. Excellent organizational skills. High accuracy in work with attention to detail. Ability to complete projects in a timely manner. Ability to get along and work cooperatively with others. Positive and professional attitude. Ability to respond positively to constructive feedback. Ability to manage a project from its initiation to completion with minimal supervision. Solution-oriented attitude with willingness to proactively solve issues. PHYSICAL DEMANDS Stand and walk or sit alternatively depending on specific needs of day. Estimate 75% of time is spent on feet and 25% sitting at desk. Have constant need to perform the following physical activities: bending/stooping/squatting, climbing stairs, pushing, pulling, twisting, lifting and reaching above shoulders. Have frequent need to perform standing and walking activities. Consistent need to perform the following physical activities: writing/typing, grasping/turning, finger dexterity. Lifting/carrying up to 50 lbs. frequently and over 50 lbs. occasionally. Vision requirements: consistent need to complete forms, view computer screen. Frequent need to see small detail. Frequent need to see things clearly beyond arm's reach. Hearing requirements: consistent need to communicate over telephone and in person. WORK ENVIRONMENT The noise level in the work environment is generally moderate but may be high during certain times of the day due to business level. This position is exposed to temperatures varying from 34 to over 70 degrees and humidity levels varying from 80 to 95%.
    $54k-93k yearly est. 2d ago
  • ServiceNow QA Manager

    Tata Consulting Services 4.3company rating

    Quality assurance specialist job in San Francisco, CA

    Must Have Technical/Functional Skills * Lead workshops to understand customer's business imperatives, technology landscape and transformation priorities. * Lead ServiceNow implementation and digital transformation journeys for ITSM, ITOM, FSM, Data Migrations, catalog forms * Interfacing implementation teams, explaining customer requirements, to ensure a successful transition and delivery execution. * Experience in ITSM, ITOM, FSM, Data Migrations, catalog forms. * Experience leading large scale implementation and transformation programs is preferable. * Experience in Advisory, Consulting, and Solutioning HRSD, WSD and S2P is preferred. * Experience in collaborating with multiple stakeholders from within the organization, customers as well as partners. * Perform framework driven assessment to benchmark customer's maturity levels across specific domains & functions. * Consult clients on improving employee experience, HR Agent experience, optimizing workflows, and simplifying HR Service Delivery. * Map customers' business problems to ServiceNow solutions. * Present a PoV to customers on how to leverage the platform to address business priorities. * Prepare business case for ServiceNow driven transformation. * Craft a solution roadmap aligned with customer's business and technology strategy * Expertise ServiceNow deployments, ITSM, ITOM, FSM, Data Migrations, catalog forms , consolidations, upgrades, integration with other third-party systems, Orchestration. * Understand Architecture Solution for the implementation or Maintenance of ServiceNow platform. * Develop a design aligned with the Architecture and technical requirements. * Work with Architect and customers for the technical requirements, document them, play back and baseline. * Work effectively with geographically diverse teams (offshore) to deliver timely responses to clients and client account teams. Roles & Responsibilities Lead a team of ServiceNow developers, web designers, integration SMEs and QA analysts to build and deploy the applications meeting the customer requirements. * Evolve business solutions, articulate as appropriate to client audiences. * Actively engages in Governance call, allowing to grasp the initial user requests' requirements effectively. * Collaborates with both internal and external stakeholders to enhance the story with relevant details, ensuring that the requirements are communicated in a clear and understandable manner for developers, thereby enhancing their productivity. * Closely collaborates with team leads and architects to facilitate the creation and documentation of appropriate solutions within the story. * Work alongside leaders to maintain awareness of the customer experience team's progress and achievements. * Diligently tracks all the stories that need to be delivered within a given timeframe. * Experience working with stakeholders to understand, document, and prioritize requirements for process and ServiceNow enhancements. * Experience defining and documenting governance processes and procedures and ensuring that the processes are followed Generic Managerial Skills, If any * Create and execute development plans as appropriate to meet changing needs and requirements. * Good Communication and presentation skills, Client handling * Thought leadership - Steer the team towards success by creating a trust environment. * Good at creating required information for Reporting and Dashboards Salary Range: $120,000 $140,000 Year TCS Employee Benefits Summary: Discretionary Annual Incentive. Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans. Family Support: Maternal & Parental Leaves. Insurance Options: Auto & Home Insurance, Identity Theft Protection. Convenience & Professional Growth: Commuter Benefits & Certification & amp; Training Reimbursement. Time Off: Vacation, Time Off, Sick Leave & Holidays. Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing. #LI-SP1
    $120k-140k yearly 22d ago
  • Quality Systems Senior Specialist

    Deerfield Management Companies 4.4company rating

    Quality assurance specialist job in San Francisco, CA

    About Us: Perceive Biotherapeutics (******************** is an exciting early-stage company, funded by Deerfield Management, with a team focused on improving human health by developing breakthrough neuroprotective therapeutics. We are using novel approaches to treat highly prevalent, blinding diseases that currently have no good therapeutic alternatives. Our unique approach is leading to first-in-class and best-in-class small molecule and gene therapy solutions that will significantly impact patients' lives. Position Summary: The Quality Systems Specialist will play a key role in ensuring the effectiveness and compliance of our Quality Management System (QMS). This position is ideal for a self-driven professional who thrives in a fast-paced, start-up environment and is passionate about contributing to the development of life-saving products. The role requires collaboration across multiple departments to maintain and improve quality systems in alignment with regulatory requirements (FDA, EMA, ICH, etc.) and industry standards. Responsibilities Key Responsibilities: Help to develop and optimize the company's Quality Management System (QMS) to ensure compliance with regulatory requirements, internal procedures, and industry standards. Support the implementation and oversight of key quality systems, such as Document Control, Supplier Management, Deviations and Complaints. Collaborate with cross-functional teams to ensure alignment of quality systems with the company's overall quality objectives and product development timelines. Lead or support investigations into quality-related issues, perform root cause analysis, and ensure timely resolution. Develop and deliver training programs on QMS procedures, quality standards, and regulatory requirements for internal staff. Review and approve quality documentation, such as SOPs, batch records, and technical reports. Assist in the preparation of regulatory submissions, including detailed review of data and reports to ensure alignment. Qualifications Qualifications: Bachelor's degree in Life Sciences, or a related field. Minimum of 5 years of experience in Quality Systems, Quality Assurance, or a related role within the pharmaceutical or biotechnology industry (medical device background considered). Strong understanding of regulatory requirements (FDA, EMA, ICH, GMP) and quality management principles. Experience with Document Control, Complaint and Supplier Management Systems in a virtual company. Ability to conduct audits and investigations into quality issues. Excellent organizational skills with the ability to manage multiple tasks and deadlines in a fast-paced environment. Strong communication skills, both written and verbal, with the ability to work collaboratively in cross-functional teams. Proficiency in MS Office and working in Box. Detail-oriented with a proactive problem-solving approach. A passion for quality, compliance, and continuous improvement in a start-up environment. Preferred Qualifications: Experience in early-stage drug development and/or manufacturing. Knowledge of quality systems software platforms. Experience with Benchling Location SF Bay Area or San Diego, CA This is a full-time contract position that is hybrid (primarily remote) with a potential to convert to full-time. Targeted annual pay band is $120,000-135,000 with some flexibility commensurate with experience. If you are a motivated and detail-oriented individual who thrives in a start-up environment and is passionate about ensuring the highest standards of quality, we would love to hear from you. Apply today to join our mission to transform the future of healthcare! Perceive Biotherapeutics provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law. #LI-DNI
    $120k-135k yearly Auto-Apply 60d+ ago
  • Quality Assurance Coordinator

    SGS Group 4.8company rating

    Quality assurance specialist job in Vallejo, CA

    We are SGS - the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world. Summary The Quality Assurance Coordinator is responsible for ensuring the laboratory's Quality Management System (QMS) complies with ISO/IEC 17025, ISO 9001,10 CFR 50 Appendix B, and 10 CFR 21 standards. This role oversees testing, calibration, and certification activities to meet regulatory, accreditation, and customer requirements. Job Functions * Maintain and improve QMS in compliance with ISO 17025 and ISO 9001 17065. * Ensure document control and proper recordkeeping for policies, procedures, and work instructions. * Serve as primary contact for accreditation bodies and regulatory agencies. * Manage accreditation audits, external assessments, and regulatory inspections. * Plan, execute, and document internal audits to assess compliance and identify risks. * Assist in Investigation of nonconformities, implement corrective actions, and verify effectiveness. * Ensure personnel involved in testing and certification are qualified, trained, and competent. * Maintain training records and competency assessments. * Conduct or coordinate quality system training sessions. * Promote continuous improvement initiatives in test methods, certification processes, and quality practices. * Assists in addressing customer complaints and ensure proper investigation and resolution. * Communicate quality system updates and compliance status to management. * Work with * staff to ensure test and certification results are accurate and reliable. Qualifications Education and Experience * High School diploma or equivalent (Required) * Bachelor's degree in relevant field preferred * 3 + years of experience in a quality role, preferably in a testing or certification environment. * Strong understanding of ISO/IEC 17025, ISO 9001, and 10 CFR 50 Appendix B, 10 CFR 21. * Writing skills for SOPs, audit reports, and compliance documentation. Knowledge, Skills, and Abilities * Critical Thinking & Problem-Solving: Ability to analyze complex quality and compliance issues. * Experienced with quality management software, document control systems, and data analysis tools. * Ability to manage multiple priorities, meet deadlines, and maintain structured documentation. * Strong writing skills for SOPs, audit reports, and compliance documentation. * Attention to Detail: Strong ability to detect nonconformities and inconsistencies. * Ability to work effectively with individuals from varied professional and cultural backgrounds. Physical Demands of the Job * Stand: None * Move or traverse: None * Sit: None * Use hands: None * Reach with hands and arms: None * Climb or balance: None * Stoop, kneel, crouch or crawl: None * Talk/hear: None * Taste/Smell: None * Lift/carry/push or pull: None Additional Information * Pay Range - $25.00 to $28.00 * Benefits - This position offers medical, dental, vision, 401K, time off benefits and participation in the company's Annual Incentive Plan. Additional Information SGS is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression, genetics, status as a protected veteran, or any other characteristics protected by law. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skills, and/or abilities required. This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company's rights to assign or reassign duties and responsibilities to this job at any time. If you are applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability, please call ************ for assistance and leave a message. You will receive a call back. Please note, this phone number is not for general employment information, but is only for individuals who are experiencing difficulty applying for a position due to a disability.
    $25-28 hourly 40d ago
  • Technical Documentation Specialist (Technician, Engineer, etc.)

    Mercor

    Quality assurance specialist job in San Francisco, CA

    Job Description Mercor is seeking technical documentation specialists to assist with a project involving the interpretation and analysis of instructional and procedural materials. This contract engagement focuses on accurately outlining operational steps, identifying system behaviors, and ensuring adherence to safety protocols. Freelancers will work with technical content that governs equipment use, process workflows, and system maintenance. 2. Key Responsibilities Analyze and document procedural steps for equipment setup, calibration, and operation Identify and explain safety mechanisms, shutdown triggers, and compliance checkpoints Evaluate documentation clarity, sequencing logic, and operational accuracy Translate technical language into structured, task-oriented formats Provide feedback on procedural consistency and safety-critical language 3. Ideal Qualifications Bachelor's degree or technical certification in engineering, operations, or a related field Experience writing or interpreting SOPs, user manuals, or technical protocols Strong attention to detail and process logic Familiarity with equipment calibration, diagnostics, or system operations preferred Comfortable working independently with high standards for accuracy and clarity 4. More About the Opportunity Remote and asynchronous - set your own schedule Expected commitment: ~10-20 hours/week Ideal for technical writers, engineers, technicians or process documentation professionals 5. Compensation & Contract Terms $45/hour You'll be classified as an independent contractor Paid weekly via Stripe Connect US-Based 6. Application Process Submit your resume to get started You may be asked to complete a short procedural writing assessment We typically follow up within 3-5 business days 7. About Mercor Mercor is a talent marketplace that connects top experts with leading AI labs and research organizations Our investors include Benchmark, General Catalyst, Adam D'Angelo, Larry Summers, and Jack Dorsey Thousands of professionals across domains like law, creatives, engineering, and research have joined Mercor to work on frontier projects shaping the next era of AI
    $45 hourly 29d ago
  • QA Specialist

    Penny Lane Centers 3.8company rating

    Quality assurance specialist job in Hillsborough, CA

    We recognize and reward top talent. If you are looking for a team environment where you can also make an individual contribution and are seeking opportunities for continual learning and development, we encourage you to apply today! Penny Lane Centers is committed to equity, diversity, inclusion and belonging within our organization by connecting our heart, our knowledge, and our understanding of the lived experience of others, to have a revolutionary impact on the marginalized communities we serve. Job Summary: Under the direction of the Quality Improvement Manager and in consultation with the Clinic Quality Improvement Director, the Quality Assurance Specialist will work to ensure that all chart documentation is accurate and in compliance with DCFS and DMH standards. The Quality Assurance Specialist will assist with ensuring the quality improvement in the Intensive Services program by conducting chart audits and making sure that corrections are made in a timely manner. The Quality Assurance Specialist will also assist with tracking the submission of documents and gathering and submitting data as needed/requested. The QA Specialist must be detail oriented and organized. This position requires excellent customer services skills and a positive attitude when working with staff. The QA Specialist must be able to work independently and follow directions that are given in a verbal or written manner. Requirements: Less than a College Degree. · 1 or more years of experience related to DMH documentation and/or maintaining charts in a clinic setting. · Must have a current valid California driver's license and current automobile insurance. Must have and maintain a clean driving record acceptable to the organization's insurance company. Must have immediate access to his or her vehicle during work hours. Position Status: Full Time (40 hours per week) Salary Range: $21.77 - $27.90 per hour Penny Lane Centers offers competitive salaries and benefits. Please visit ***************** to see a complete list of perks and benefits. Medical benefits are effective the first of the month upon hire, not to exceed 31 days. Equal Employment Opportunity. Penny Lane is committed to equal employment opportunity. We will not discriminate against employees or applicants for employment on any legally recognized basis (Protected class) including, but not limited to race; religious creed; color; national; origin; ancestry; physical disability; mental disability; medical condition, including genetic characteristics; genetic information; marital status; sex; pregnancy' child birth or related medical conditions; actual or perceived gender; gender identity or expression or sexual orientation. Our management is dedicated to ensuring the fulfillment of this policy with respect to hiring, placement, recruitment advertising, pay and other forms of compensation, training and general treatment during employment.
    $21.8-27.9 hourly Auto-Apply 9d ago
  • Assurance Experienced Associate

    BDO Global 4.8company rating

    Quality assurance specialist job in San Francisco, CA

    The Assurance Experienced Associate will be responsible for preparing financial statements with disclosures, applying basic areas of GAAP as necessary and documenting, validating, testing, and assessing various control systems. This position may also be involved in reviews and agreed-upon procedure engagements. Job Duties: Control Environment: * Applies knowledge and understanding of the collective effect of various factors on establishing or enhancing effectiveness, or mitigating the risks, of specific policies and procedures by: * Identifying and considering all applicable policies, laws, rules, and regulations of the firm, regulators, or other authoritative bodies as part of engagement team * Making constructive suggestions to improve client internal controls and accounting procedures * Documenting and validating the operating effectiveness of the clients' internal control system GAAP: * Applies knowledge and understanding of governing principles; applying these principles to client transactions; and documenting and communicating an understanding and application of these principles by: * Providing support of conclusions with authoritative literature * Drafting basic sets of financial statements with disclosures * Researching intermediate areas of accounting and forming an initial opinion on the correct treatment independently GAAS: * Applies knowledge and understanding of professional standards; application of the principles contained in professional standards; and the ability to document and communicate an understanding and application of professional standards on an engagement by: * Developing and applying an intermediate knowledge of auditing theory, a sense of audit skepticism, and the use of BDO audit manuals * Applying auditing theory to various client situations * Documenting in line with BDO policy, identifying deviations and notifying more senior team members in order to obtain appropriate approvals * Applying knowledge to identify instances where testing may be reduced or expanded and notifying more senior team members of the occurrence * Contributing ideas/opinions to the engagement teams Methodology: * Applies knowledge and application of BDO standards to guide effective and efficient delivery of quality services and products by: * Completing all appropriate documentation of BDO work papers * Ensuring assigned work is performed in accordance with BDO methodology and requirements Research: * Applies methodology used to seek or maintain information from authoritative sources and to draw conclusions regarding a target issue based on the information by: * Researching basic and intermediate accounting topics and forming an initial opinion on the treatment independently * Other duties as required: Supervisory Responsibilities: * N/A Qualifications, Knowledge, Skills and Abilities: Education: * Bachelor's degree in Accounting, Finance, Economics or Statistics, required OR Bachelor's degree in other focus area and CPA certification, required * Master's in Accountancy, preferred Experience: * One (1) or more years of prior relevant audit experience and/or public accounting, private industry accounting or consulting/professional services experience, required License/Certifications: * Eligible to sit for the CPA exams upon starting employment required and actively pursuing completion of the exams, required * CPA, preferred Software: * Proficient with the Microsoft Office Suite, preferred * Experience with assurance applications and research tools, preferred Language: * N/A Other Knowledge, Skills & Abilities: * Basic understanding and experience planning and coordinating the stages to perform an audit of a basic public and/or private company * Ability and willingness to travel, as needed * Knowledge of internal accounting controls and professional standards and regulations (GAAP, GAAS, Sarbanes-Oxley, etc) * Strong verbal and written communication skills with the ability to adapt style and messaging to effectively communicate with professionals at all levels both within the client organization and the firm * Ability to successfully multi-task while working independently and within a group environment * Solid analytical and diagnostic skills and ability to break down complex issues and implementing appropriate resolutions * Ability to of work in a demanding, deadline driven environment with a focus on details and accuracy * Solid project management skills Individual salaries that are offered to a candidate are determined after consideration of numerous factors including but not limited to the candidate's qualifications, experience, skills, and geography. California Range: $83,000 - $90,000 Cleveland, Ohio Range: $70,000 - $78,000 Colorado Range: $75,000 - $80,000 Illinois Range: $76,000 - $82,000 Maryland Range: $72,000 - $78,000 Minnesota Range: $70,000 - $74,000 NYC/Long Island/Westchester Range: $75,000 - $80,000 New Jersey Range: $76,500 - $83,000 Washington Range: $80,000 - $85,000
    $83k-90k yearly 60d+ ago
  • Quality Assurance Coordinator

    Abode 3.9company rating

    Quality assurance specialist job in San Leandro, CA

    Abode, one of the largest and effective nonprofits working to end homelessness in the Bay Area, is seeking a Quality Assurance Coordinator for our programs in Alameda County. About The Role: The Quality Assurance Coordinator will supervise the Billing Coordinator while providing support and assistance to the Program Manager, Clinical Supervisor, and other administrative staff to ensure clinical and quality assurance and improvement of billing and data systems, charts, electronic health records, etc.   The People and Culture: You will be surrounded by some of the most talented, supportive, smart, and kind leaders and teams - people you can be proud to work with! Abode Services regularly recognizes employees' efforts, seeks employees' input, and cares for employees as people with lives outside of work. We believe that we make better decisions and provide quality services when our workforce reflects the diversity of the communities in which we operate. People of color make up nearly 70% of our workforce and we strive to recruit and retain employees from all backgrounds. Our Benefits & Perks: $70,000 - $85,000 annually DOE 100% paid health, vision, and dental options 19 PTO days & 12 Holidays per year Voluntary benefits: FSA, EAP, Commuter Checks, Life Insurance, Legal, and more 3% retirement match/contribution Professional Development Trainings and Opportunities, Leadership Academy Programs, and All Staff Events Dynamic, mission-driven culture and supportive leadership. We support you in supporting others How You Make An Impact: Supervise Billing Coordinator. Assist in planning, organizing, developing, evaluating, and when necessary, revising Utilization Review processes. Maintain outcome data for the agency that includes the following: examination of aggregate data on outcomes and identification of potential problems and/or patterns of outliers. Develop a data/billing/evaluation plan, which lays out what systems, processes, and other infrastructures are needed to better manage our data systems and then use the data to inform the efficacy and evaluate our delivery of services. Develop outcome reports and present data for distribution. Assist in the evaluation of program outcomes and in preparing reports on program outcomes. Assist Clinical Supervisor and Program Manager in internal monthly audits of charts (CQRT), looking for accuracy, completion, quality, and compliance with internal and external regulations; provide summaries and feedback to managers; identify and follow up on plans of correction.   Work with county representatives to ensure Abode complies with Medicare and Medi-Cal utilization review regulations. Provides information on Medicare and Medi-Cal Utilization Review requirements to clinical, supervisory, and management staff. A willingness to become the subject matter expert in Medi-Cal regulations and the policies/procedures of each of our contract counties is a must. Participate with staff in utilization and quality improvement meetings and projects. Compile, track, and review denied services; represent Abode in appeal of any adverse decisions. Oversee the process for new and closed charts including tracking, printing, filing, and storage. Provide support to direct service staff in the efforts to complete charts by specified deadlines and to meet Medi-Cal standards. Ensure compliance with HIPAA requirements. Work with County Staff to obtain staff IDs and inform managers of changes in county policy and procedures. Responsible for training new staff on office policies and protocols related to quality assurance and improvement. Establish and maintain positive, collaborative relationships with program staff. Assist the Program Manager, Clinical Supervisor, and other staff as needed. Other duties as assigned. How You Meet Qualifications: Bachelor's degree in psychology, Human Services, Social Work, Sociology, or related field or equivalent Quality Assurance experience Two years of experience in the Medi-Cal utilization review process.  Work flexible hours, including occasional weekends and evenings when required. Reliable transportation and proof of a valid and current California Driver's License and current insurance along with a clean DMV record required.   Competencies: Excellent verbal & written communication, organizational, and time management skills. Strong analytical and problem-solving skills with meticulous attention to detail. Experience in and expansion of a solid understanding of county billing systems, data systems, and Electronic Health Records systems.   Experienced knowledge of health care laws and regulations, including HIPAA and the principles and practices of information privacy laws, access, release of information and release control technologies. Practiced in demonstrating the ability to relate to people effectively, sensitively, and respectfully from different cultural groups.  Ability to work well independently and collaboratively with teams. Experience providing supervision and direction to staff.  Knowledge of principles and methods for practices of project planning, system analysis, monitoring, problem solving, implementation and evaluating, development and evaluation.  Understanding and knowledge of pertinent laws and regulations regarding mental health and social service programs and the ability to apply state, federal, and local regulations related to quality assurance and utilization review. A thorough working knowledge of Medi-Cal regulations and requirements.  Proficiency in Microsoft Office programs, systems, and platforms. Ability to learn and use required mobile devices and business-related applications. Outstanding communication skills and high degree of emotional intelligence, cultural humility, with a proven track record to build and maintain effective relationships with a wide variety of internal and external contacts. Notice: This description is to be used as a guide only. It does not constitute a contract, commitment or promise of any kind. Abode Services reserves the right to change, add, delete, upgrade, or downgrade the position as dictated by business necessity at any time with or without notice. Notice: Abode Services is an Equal Opportunity Employer/Drug Free Workplace.
    $70k-85k yearly 27d ago
  • (CW) QA Associate

    Biomarin Pharmaceutical 4.6company rating

    Quality assurance specialist job in Novato, CA

    Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Technical Operations BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. This is a Contract role-**Onsite 5 days per week in Novato, CA. Possibility of working offsite when fully trained*** QA Associate Description: This position within the QA department provides Quality oversight, support and knowledge to activities relating to Quality to meet BioMarin business priorities. The QA Associate will have proven capability in promoting Quality across cross-functional teams, to deliver high quality product, ensuring continuous process improvement. The QA Associate will model the BioMarin Leadership behaviors and understand the principles to drive a culture of continuous improvement building a High-Performance Organization. General QA Associate Responsibilities: ●Exercise judgment to determine appropriate action, ensuring proper escalation when non-conformances are identified as per applicable procedures for compliance, escalation and corrections. ●Provide Quality input to Deviations ensuring scope of record is clear and investigations are robust and timely. Review and approval of Deviations and associated CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable. ●Participates within inter-departmental and cross-functional teams, with direct interface with Manufacturing, Supply, Distribution, Maintenance, Metrology, and Quality Control employees to immediately address issues and questions in real time to help ensure timeline are achieved to meet customer requirements. Minimizing impact to Lot Release operations on site. ●Prioritizes tasks to ensure the critical tasks are completed on time and meet requirements. Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled 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, or protected veteran status and will not be discriminated against on the basis of disability.
    $61k-73k yearly est. Auto-Apply 27d ago
  • Assistant Quality Assurance Associate

    Merito Group

    Quality assurance specialist job in San Francisco, CA

    Want to get your foot in the door with a large multinational organization? When was the last time you had a good meal and it changed your day? Now, multiply that experience a thousand times over and you get the sense of how much your work with this catering organization can impact customers. Working as a Quality Assurance Associate, you will work in an incredibly fast-paced and changing environment within the airline industry. Your position is especially important as your work will have a direct impact on customers and their in-flight meal experience. You will be responsible for making sure all in-flight meals go above and beyond expectations from initial preparation to delivery. Your care and attention to detail will make all of the difference in the customer experience and set you up to grow in your career. What's in It for You? This company is worldwide, and the San Francisco location could be the first of many stops if you want to grow in your career. This is a "hands-on" position, and you can expect to add MANY new bullet points to your resume as this is a "jump in and grow" sort of environment. As part of your work, all meals will be provided to you while on shift. Your Skills and Experience If you gravitate towards a fast-paced and ever-changing environment, this could be a great place to propel your career. The ideal candidate has a ServSafe certificate and experience in an airline or customer service environment. Your Application If you think you have what it takes to perform in an environment with lots of growth potential, lots of change, and lots of impact, apply here. We are working for the company to find the best candidates. After a resume review, the process will include a phone screen, a discussion of your goals and interests, a webcam interview, and interviews with the client company. This can all happen within the week.
    $50k-78k yearly est. 43d ago
  • Sr. Food Safety & Quality Assurance Compliance Manager

    Patagonia Inc. 4.5company rating

    Quality assurance specialist job in Sausalito, CA

    Role: Sr. Food Safety & Quality Assurance Compliance Manager Team: Operations, Patagonia Provisions Scope: Individual Contributor, P4 Experience: 7-10 years Patagonia Provisions makes delicious, carefully sourced products best enjoyed from trailheads to campsites and beyond. We work to address specific environmental problems through organic, regenerative and responsible food production. Our food system is broken; Patagonia Provisions is about finding solutions to repair it. We are in business to save our home planet. The Sr. FSQA & Compliance Manager at Patagonia Provisions is tasked with overseeing and enhancing the food safety and quality assurance systems across the supply chain. Responsibilities include evaluating risks for new products and facilities, supporting cross departmental efforts in the areas of food safety and quality, and developing comprehensive documentation and procedures to identify risks, implement controls, and track outcomes. The role requires attention to detail for managing complex information and translating it into actionable strategies to improve product safety and consistency. Serve as the subject matter expert on food safety regulations, quality controls, certifications and a drive for continuous improvement in our programs and policies. What You'll Do: Leadership * Develop and execute Patagonia Provisions' FSQA strategy aligned with brand values, sustainability targets, and business objectives. * Establish and monitor key performance indicators (KPIs) for food safety, quality, and compliance across the supply chain Supplier & Manufacturer Oversight * Manage supplier qualification, risk assessments, and verification programs. * Oversee co-packer performance and compliance with regulatory, customer, and internal standards (FDA, USDA, FSMA, BRC, Organic, ROC, etc.). * Conduct site audits and coordinate third-party evaluations; verify and track corrective actions. * Maintain supplier risk matrices and annual audit schedules to ensure accountability and transparency. * Review production samples and provide timely feedback and corrective actions. Product Safety, Quality and Compliance * Lead HACCP, HARPC, and Preventive Controls programs; serve as the PCQI for applicable facilities. * Manage all analytical and microbiological testing programs, including annual test plans and budgets. * Oversee certifications (Organic, Non-GMO, ROC, Kosher, Fair Trade, etc.) and liaise with certifying bodies. * Maintain recall readiness through annual mock recalls; serve as Recall Coordinator during real events. * Partner with Legal, Marketing, and Regulatory teams to validate product claims and labeling compliance. Documentation, Traceability & Risk Management * Ensure FSQA systems are fully documented, current, and audit ready. * Oversee document control, allergen management, ingredient/sub-supplier approvals, and COA verification. * Conduct risk assessments for new products, ingredients, and packaging. * Support digital traceability and sustainability data integration initiatives. Quality Feedback and Traceability * Evaluate consumer and customer feedback to identify quality trends and drive corrective actions. * Provide responses to the CX [Customer Service] team to customer inquiries related to product quality and safety. * Lead root cause analysis (RCA) and corrective/preventive action (CAPA) processes with suppliers and internal teams. * Track and report FSQA metrics including complaint rates, audit outcomes, and nonconformance trends. Cross-Functional Collaboration * Partner with Product Development to embed FSQA principles from concept through commercialization. * Work closely with Operations and Supply Chain on product validations, supplier transitions, and first production runs. * Collaborate with Legal and Marketing to ensure product integrity, accurate claims, and compliant labeling. * Support Sales with customer documentation needs related to food safety programs. * Performs other duties as assigned by manager. Who You Are: * Passionate - Have passion for the mission of Patagonia Provisions and making a change in food/agriculture space. * Organized - Able to put plans together and keeping the team/project ahead of schedule * Detail Oriented - Accuracy matters, and no detail is too small. * Innovative - Proven skill at problem-solving and thinking outside of the box. * Entrepreneurial - Scrappy and comfortable in the "gray" and wearing many hats. * Inclusive - Deeply experienced in collaborating with others across differences. Experience You Bring: * BS or MS in Food Science, Microbiology, or related field. * 8-10+ years of progressive FSQA experience in food manufacturing or CPG environments. * PCQI and HACCP required; SQF/BRC auditor credentials preferred. * Robust attention to details and highly organized record keeping and process improvement. * Experience leading audits, recalls, and certification programs (Organic, ROC, Non-GMO, Kosher, Fair Trade, etc.). * Expertise in FDA, FSMA, USDA, Prop 65, and global food regulations. * Advanced proficiency in Excel and QA systems; experience with Power BI or digital traceability platforms is a plus. * English Required, proficiency is Spanish a plus. * Excellent written, verbal, and analytical skills. * Able to effectively prioritize workload and work independently in a startup environment. * Ability to travel domestically and internationally (up to 30%). Hiring Range: $135,000 to $155,000 USD Annual At Patagonia, pay ranges are assigned to a job based on the location specific market median of similar jobs according to 3rd party salary benchmark surveys. Individual pay within that range can vary for several reasons including skills/capabilities, experience, and available budget. Note the full pay range for this role ranges from $110,480.00 - $165,720.00 USD Annual. The Hiring Range reflects where in the range we intend to hire for this role. Benefits Patagonia offers a comprehensive benefits package, including medical, dental, vision, retirement and leave of absence plans. Benefit plans may vary slightly depending on the nature of your employment. Employee Conduct It is the responsibility of every employee to contribute to a positive, inclusive work environment through cooperative and professional interactions with co-workers, customers and vendors. Equal Employment Opportunity All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.
    $135k-155k yearly Auto-Apply 18d 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
  • Quality Assurance Specialist

    Upshift

    Quality assurance specialist job in San Francisco, CA

    Who we are: Modernize is one of the fastest growing energy efficiency marketplaces in the USA. We've been in business for 11 years and last year we helped over 250,000 Americans save money by going green. We partner with large solar companies like Sunpower to sell their products to homeowners. What we believe: We're passionate about helping homeowners nationwide save money and protect the planet. We believe that making money doesn't have to come at the expense of doing good. We believe that people should be able to do meaningful work on their own schedule. Every day we're excited to get up and make a difference in people's lives. If you're passionate about this cause and want to contribute we'd like to talk to you. What you'll be doing: The role and responsibility of this role is to audit our sales agents calls and score them to provide a real time feedback mechanism. Measurable accountabilities: Review and audit a minimum of 15 calls per hour. Score calls on a 5 point scale Work a minimum of 5 hours per week Requirements for the role: 1 year experience doing call auditing Hardwired internet connection Double monitor Benefits and Compensation: - Paid training, competitive base hourly rate at $13 per hour - Flexible schedule and no commute
    $13 hourly 60d+ ago
  • Senior Operations QA Clinical GLP Manager

    Exelixis 4.9company rating

    Quality assurance specialist job in Alameda, CA

    SUMMARY/JOB PURPOSE: The Senior Operations QA Clinical GLP Manager is accountable for assisting in the development, implementation and maintenance of end-to-end QA processes and activities, including GLP operations. Provide Operations QA oversight of day-to-day end-to-end (Drug Substance, Drug product, Finished Goods) GMP Operations at the Contract Manufacturing Organizations (CMOs) that manufacture and test Exelixis development and clinical products, including batch record review, assessment, rapid escalation and issue resolution, release per supply plans, and managing product complaints. Represents QA as the QA Partner (Primary Point of Contact), speaking One Voice for Quality for Exelixis business stakeholders, represents QA in an outwardly and business-facing capacity, in strategic and decision forums, and triages communication between Exelixis business functions, internally or externally, and QA, to provide and ensure delivery on the company core goals and pipeline deliverables. Manages Exelixis partnerships, collaborations. audits, forges strong relationships to maintain performance and continuous improvement. Demonstrates a high level of independent quality judgment and acumen, and knowledge and experience with GLP regulations, biologic and chemical processes, drug development, analytical testing methods, and understanding of the international regulatory landscape. ESSENTIAL DUTIES/RESPONSIBILITIES: Represent QA as the QA Partner (Primary Point of Contact) (vendors, CMOs, development collaborators for contracts, validation, change management, GMP and GLP issues). Develop, implement, and continuously improve QA programs, policies and procedures to ensure GMP and GLP compliance of clinical trial material, and onsite labs. Perform record review, and batch disposition for commercial and clinical trial material, including comprehensive Quality assessment, and review of GLP documents and records. Oversee CMOs and GLP vendors, as applicable: Issue/deviation management, CAPAs with vendors and cross-functional teams to resolve potential product quality issues, rapidly escalate and resolve issues. Generate, review/approve internal and external GMP records (MBR and EBR (master and executed batch records), stability reports/protocols, specifications, deviations, change controls, testing and labeling/packaging records, development/CMC documents submitted to regulatory agencies, GLP documents and records, etc.) Responsible for developing, tracking and managing periodic management reports, including key GMP and GLP compliance and QA metrics, as applicable. Maintain and report CMO metrics and Operations QA metrics. Evaluate and generate data to support KPIs (Key Performance Indicators). Identify and rapidly mitigate risk. Independently determines approach to complex compliance issues and rapidly escalates reports findings, with recommendations for resolution, and verifies that appropriate CAPAs were implemented and documented. Contribute to APQR (annual product quality review) as applicable. Support implementation of quality systems, departmental and corporate procedures, to ensure compliance with cGMPs and GLP. Partners with Regulatory Affairs, Clinical Pharmacology, Translational Medicine, PSC, PSC Analytical, and R&D as it pertains to GLP, etc., regarding compliance issues, provides compliance guidance to all audited parties. Maintains knowledge of current regulation requirements; informs stakeholders of potential impact on the organization. Deliver per supply plans, drive results. SUPERVISORY RESPONSIBILITIES: No supervisory responsibilities. EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education: Bachelor's degree in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 9 years of related experience; or, Master's degree in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 7 years of related experience; or, PhD in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 2 years of related experience; or, Equivalent combination of education and experience. Experience: A minimum of 8 years of related QA experience or the equivalent combination of experience and education/training. Experience in the biotech or pharmaceutical industry, and clinical packaging/labeling activities is preferred Two years' experience managing Contract Manufacturing Organizations preferred Five years general experience in biotech/pharmaceutical industry. Experience in development of metrics and continuous improvements is preferred Knowledge, Skills and Abilities: Demonstrated knowledge of the drug development processes Demonstrated GLP audit conduct and management experience is required. Working knowledge of supporting GLP preparation and submission activities for global regulatory filings. Working knowledge of the end-to-end commercial and clinical manufacturing and quality processes, including US/EU regulations affecting the pharmaceutical industry, and ICH guidelines. Proven experience in a virtual manufacturing environment or relevant industry/profession. Requires a broad range of knowledge and experience with biologic and chemical processes, drug development, analytical testing methods, laboratory practices and tox studies, and understanding of the international regulatory landscape. Small molecule, oral solid form, biologics technical knowledge required. Uses broad expertise or unique knowledge and skills to drive meeting company core objectives and principles, and to achieve goals in creative and effective ways. Implements technical solutions within quality requirements to complex problems. Interprets, executes and recommends modifications to companywide policies and/or divisional programs. Great attention to detail. Applies strong analytical and business communication skills. Evaluates and generates data to support departmental metrics. Excellent written, verbal and presentation communication skills, able to translate complex concepts across all levels of the organization. Excellent MS Office, Word, Excel and PowerPoint skills. Work Environment/Physical Demands: This is an onsite position Our office is a modern, open-plan space that foster collaborations and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace. This position requires up to 5% travel. #LI-HG1 If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us! Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $165,000 - $235,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year. DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
    $165k-235k yearly Auto-Apply 60d+ ago
  • Assurance Experienced Associate

    BDO USA 4.8company rating

    Quality assurance specialist job in San Francisco, CA

    The Assurance Experienced Associate will be responsible for preparing financial statements with disclosures, applying basic areas of GAAP as necessary and documenting, validating, testing, and assessing various control systems. This position may also be involved in reviews and agreed-upon procedure engagements. Job Duties: Control Environment: Applies knowledge and understanding of the collective effect of various factors on establishing or enhancing effectiveness, or mitigating the risks, of specific policies and procedures by: Identifying and considering all applicable policies, laws, rules, and regulations of the firm, regulators, or other authoritative bodies as part of engagement team Making constructive suggestions to improve client internal controls and accounting procedures Documenting and validating the operating effectiveness of the clients' internal control system GAAP: Applies knowledge and understanding of governing principles; applying these principles to client transactions; and documenting and communicating an understanding and application of these principles by: Providing support of conclusions with authoritative literature Drafting basic sets of financial statements with disclosures Researching intermediate areas of accounting and forming an initial opinion on the correct treatment independently GAAS: Applies knowledge and understanding of professional standards; application of the principles contained in professional standards; and the ability to document and communicate an understanding and application of professional standards on an engagement by: Developing and applying an intermediate knowledge of auditing theory, a sense of audit skepticism, and the use of BDO audit manuals Applying auditing theory to various client situations Documenting in line with BDO policy, identifying deviations and notifying more senior team members in order to obtain appropriate approvals Applying knowledge to identify instances where testing may be reduced or expanded and notifying more senior team members of the occurrence Contributing ideas/opinions to the engagement teams Methodology: Applies knowledge and application of BDO standards to guide effective and efficient delivery of quality services and products by: Completing all appropriate documentation of BDO work papers Ensuring assigned work is performed in accordance with BDO methodology and requirements Research: Applies methodology used to seek or maintain information from authoritative sources and to draw conclusions regarding a target issue based on the information by: Researching basic and intermediate accounting topics and forming an initial opinion on the treatment independently Other duties as required: Supervisory Responsibilities: N/A Qualifications, Knowledge, Skills and Abilities: Education: Bachelor's degree in Accounting, Finance, Economics or Statistics, required OR Bachelor's degree in other focus area and CPA certification, required Master's in Accountancy, preferred Experience: One (1) or more years of prior relevant audit experience and/or public accounting, private industry accounting or consulting/professional services experience, required License/Certifications: Eligible to sit for the CPA exams upon starting employment required and actively pursuing completion of the exams, required CPA, preferred Software: Proficient with the Microsoft Office Suite, preferred Experience with assurance applications and research tools, preferred Language: N/A Other Knowledge, Skills & Abilities: Basic understanding and experience planning and coordinating the stages to perform an audit of a basic public and/or private company Ability and willingness to travel, as needed Knowledge of internal accounting controls and professional standards and regulations (GAAP, GAAS, Sarbanes-Oxley, etc) Strong verbal and written communication skills with the ability to adapt style and messaging to effectively communicate with professionals at all levels both within the client organization and the firm Ability to successfully multi-task while working independently and within a group environment Solid analytical and diagnostic skills and ability to break down complex issues and implementing appropriate resolutions Ability to of work in a demanding, deadline driven environment with a focus on details and accuracy Solid project management skills Individual salaries that are offered to a candidate are determined after consideration of numerous factors including but not limited to the candidate's qualifications, experience, skills, and geography. California Range: $83,000 - $90,000 Cleveland, Ohio Range: $70,000 - $78,000 Colorado Range: $75,000 - $80,000 Illinois Range: $76,000 - $82,000 Maryland Range: $72,000 - $78,000 Minnesota Range: $70,000 - $74,000 NYC/Long Island/Westchester Range: $75,000 - $80,000 New Jersey Range: $76,500 - $83,000 Washington Range: $80,000 - $85,000
    $83k-90k yearly Auto-Apply 60d+ ago

Learn more about quality assurance specialist jobs

How much does a quality assurance specialist earn in Novato, CA?

The average quality assurance specialist in Novato, CA earns between $52,000 and $131,000 annually. This compares to the national average quality assurance specialist range of $41,000 to $97,000.

Average quality assurance specialist salary in Novato, CA

$82,000
Job type you want
Full Time
Part Time
Internship
Temporary