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Sr. Director, Global QA Clinical Quality Assurance-logo
Sr. Director, Global QA Clinical Quality Assurance
Structure Therapeutics IncSouth San Francisco, CA
Structure Therapeutics develops life‐changing medicines for patients using advanced structure‐based and computational drug discovery technology. The company's platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs. We are advancing a clinical‐stage pipeline of differentiated treatments focused on chronic diseases with high unmet need, including cardiovascular, metabolic, and pulmonary conditions. Structure Therapeutics is led by an experienced group of international drug innovators and financed by top-tier global life sciences investors. The company has completed an initial public offering (IPO) in February of 2023. With offices in California and Shanghai, Structure Therapeutics has the benefit of being at the center of life science innovation in both the US and China and capitalizing on the strengths of each geographic location. POSITION SUMMARY The Sr. Director, Global QA Clinical Quality Assurance is responsible for development, governance, and management of GCP and ensuring other product development and PV activities comply with applicable national and international standards, regulations, and guidelines. The position will provide support and promote collaboration internally to ensure all systems, processes and their outcomes remain compliant. The position will also provide quality oversight of multiple programs in development, based on company goals. Preference is for local candidates, and we are moving to a 4-day work week/in the SSF QC office If remote, you will be required to work in SSF QC office one week a month ESSENTIAL DUTIES AND RESPONSIBILITIES Support the preparation and implementation of regulatory strategies, for new drug Lead Clinical Quality oversight, including creation and revision of SOPs and training programs for GCP compliance Ensure involvement of Quality from early phases of development through collaboration with Clinical Science, Clinical Operations, RA, PV etc. to influence effective processes and program oversight Lead in preparation and support of regulatory inspections and partner diligence audits in cooperation with multiple internal functions as well as external vendors/3rd parties. Provide training and support for inspections at sites, CROs and service providers Serve as QA representative on clinical study development teams; participate in the review and approval of clinical trial "essential documents" (e.g. protocols, ICF, etc.) Evaluate vendors for potential use; conduct and/or manage qualification inspections of GCP suppliers and service providers Create and execute clinical study audit plans, perform routine and for-cause audits of clinical investigator sites, and review of TMFs and CSRs Lead and participate in cross functional working groups to identify and mitigate GCP quality and compliance issues. Create, monitor, and improve a QMS with focus on development phases Oversee GCP activities (including internal or external audit observations and development of adverse trends) in order to ensure patient safety and data integrity Lead, investigate, and/or oversee quality issues including CAPAs and closures including defining and monitoring key quality metrics in support of management reviews Participate in department cross-training and lead/support during regulatory inspections, serving as QA clinical expert and host inspections as needed. Assess GCP and GLP compliance risk areas and develop and implement risk mitigation measures Maintain a contemporary knowledge of current agency and industry trends, standards, and methodologies as related to GCPs Other duties as assigned REQUIREMENTS Education BS/MS or equivalent in a relevant scientific discipline. Graduate level in a science or engineering related discipline preferred Experience 10 -12+ years' experience in clinical quality assurance ensuring sponsor oversight including performing GCP audits for clinical stage pharmaceutical companies with at least 5 years' experience in an out-sourced environment Thorough experience in quality function, overseeing clinical quality within European guidelines and regulatory standards 5+ years' experience with Pharmaceutical Quality Assurance in the US. Strong HA inspection experience with FDA, MHRA, EMA, and/or PMDA is desirable Has a bias for action and display a sense of urgency Must possess strong skills in leadership, communication, project management, and budget management Demonstrated ability to collaborate, communicate and ensure quality oversight through external parties A working knowledge of databases, including Electronic Document Management Systems (EDMS), is desirable In‐depth knowledge of and ability to interpret and apply GCP, GLP, EU, FDA and ICH regulations, guidelines, and best practices SQA RQAP certification is a plus Full understanding of and practical experience establishing and fostering compliance with ICH E-6 Guideline for Good Clinical Practice and Good Pharmacovigilance Additional certifications as an auditor as well as training regulatory frameworks highly desirable. Expertise in data integrity and CFR Part 11 required Ability to travel 10-30% domestically and internationally The target salary range for this full-time role is $255,000 - $306,000 + bonus + equity + benefits. Structure Therapeutics determines salary ranges based on level and scope of responsibilities, as well as location. Individual pay is further determined by additional factors, including relevant experience, specific job skills, education and training. More details about the specific salary range for your location will be discussed with you during the hiring process by the StructureTx Talent Acquisition Team.

Posted 30+ days ago

QA Shop Floor Specialist-logo
QA Shop Floor Specialist
SanofiRidgefield, NJ
Job title: QA Shop Floor Specialist Location: Ridgefield, NJ Shift: 10pm to 6am About the Job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Join our Biosurgery Quality Team as a QA Shop Floor Specialist and you'll ensure compliance with cGMP, regulatory, and internal requirements regarding the manufacturing, testing, and distributing of products through formal QA walkthroughs, Audits and Investigations that may result in additional training and recommendations to procedural improvements. Evaluate and provide QA recommendations for all products, systems, facilities, and issues that are affected or may be affected by regulatory or cGMP requirements. Increase quality culture in the manufacturing areas. Enhance technical knowledge of operators and shop floor managers by providing positive and constructive feedback. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main Responsibilities: Conduct QA Shop Floor Walkthrough and Audit based on schedule and assignment Documentation of appropriate findings and support area improvement Support the Lead and Manager to drive QA shop floor program and address concerns with manufacturing and driving quality improvements Mentoring and coaching QA Shopfloor personnel Coaching manufacturing team, when required Collaboration with manufacturing on process improvements Area/Line clearances, when requirerd Review documentation- BPRs, Logbooks Deviation support, when required Perform audits, walk-throughs, GEMBAs, technical coaching Support Lead and Manager with tasks as needed (Change Control, Deviations etc) Support Additional Quality functions (Media Fill Observer, Documentation Updates etc) About You Basic Qualifications/Requirements: Bachelor's Degree in Life Sciences or Engineering with 2-3 years' experience in a cGMP controlled/ pharmaceutical industry with a demonstrable working knowledge of contamination control, aseptic processing, cGMPs and regulatory requirements. Or 3 years or more of relevant experience in a cGMP controlled/ pharmaceutical industry with a demonstrable working knowledge of contamination control, aseptic processing, cGMPs and regulatory requirements in lieu of degree Must have Aseptic Manufacturing and Quality Auditing Experience Has experience with Filling machines in Grade A Worked in a Microbiology laboratory or Aseptic Production/Manufacturing Facility environment Advanced knowledge of MS Office including Excel, PowerPoint, and Word. The shift for this position is from 10pm to 6am. Preferred Qualifications: Packaging experience is preferred Decision making, auditing, and deviation investigations. Demonstrated willingness to learn, teamwork abilities, excellent communication, adaptability, organizational and analytical skills, and a strong interest in the pharmaceutical and bio-pharmaceutical industry. Must have excellent written and verbal communication skills Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SG #LI-GZ #LI-Onsite #vhd Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. North America Applicants Only The salary range for this position is: $57,000.00 - $82,333.33 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.

Posted 1 week ago

QA Specialist I/Ii-logo
QA Specialist I/Ii
KBI BiopharmaDurham, NC
At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact. The Manufacturing Quality Assurance (MQA) Specialist is responsible for supporting the Manufacturing Process and Areas as part of a rapidly expanding GMP Contract Manufacturing Organization. MQA Specialists are expected to provide sound guidance to Manufacturing with respect to process, SISPQ of product, and risk. MQA Specialists share responsibility for the inspection readiness of the site. MQA Specialists routinely work on the cleanroom floor directly with the Manufacturing team to provide real time guidance and support. Specialists routinely collaborate with Manufacturing and work on team initiatives. The MQA Specialist may also be responsible for coaching and mentoring as needed to foster a GMP compliant site. In addition to supporting Manufacturing, MQA Specialists are responsible for the execution of core activities during a 12-hour 2-2-3 schedule, including but not limited to: Executed Batch record review and approval Logbook review and approval Deviation guidance and generation Routine facility walkthroughs Facility response for work compromising clean environment. SOP review Bulk Fill Label reconciliation Alarm response and acknowledgement Support external client review and resolution of comments. Creation and Release of electronic Batch Records, electronic Solution Records, electronic Equipment Preparation Records, etc. in MODA-ES Admin Client MQA Specialist I High School diploma or equivalent. Degree progression preferred. GMP / regulated industry / laboratory experience is required (approximate 1-3 years). Demonstrated ability to work in a team environment. Demonstrated ability to understand the manufacturing process. Ability to perform routine core MQA responsibilities. Review written procedures for accuracy and provide feedback as needed MQA Specialist II Associate degree / Bachelor's degree strongly preferred or appropriate years of experience (approximate 3-6 years). Demonstrated ability to work in a team environment and strong communication skills within all levels of an organization. Demonstrated ability to represent Quality on interdepartmental meetings. Demonstrated knowledge of technical documents. Demonstrated ability to become qualified trainers. Ability to track and trend department metrics. Review written procedures for accuracy and provide feedback as needed Salary Range: MQA Specialist I: $55,000 - $75,900 MQA Specialist II: $63,000 - $86,900 Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate's qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching with 100% vesting in 60 days and employee recognition programs. About KBI: KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit www.kbibiopharma.com. KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. That's why we actively seek individuals from all backgrounds - regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status - and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team. KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

Posted 5 days ago

Qa/Qc Specialist - Journeyman-logo
Qa/Qc Specialist - Journeyman
Caci International Inc.Doral, FL
QA/QC Specialist- Journeyman Job Category: Project and Program Management Time Type:Full time Minimum Clearance Required to Start: Secret Employee Type: Regular Percentage of Travel Required: Up to 10% Type of Travel: Local CACI is seeking an experienced QA/QC Specialist to support our customer, U.S. Southern Command (USSOUTHCOM), in Doral, Florida. This position is contingent upon award of the USSOUTHCOM Cyber Information Technology Enterprise Services (SCITES). Key Responsibilities QA/QC Specialist- Journeyman: Assists in ensuring the quality control and timely production of program deliverables Identifies and implements quality control approaches that align with task order requirements Participates in development and facilitation of project Kick-Off Meetings Contributes to the development, delivery, and maintenance of the PMP, including management approaches, organizational structure, work breakdown structure (WBS), risk assessment/mitigation strategies, operating procedures, and Standard Operating Procedures (SOPs) Coordinates and participates in monthly PMRs Tracks and retains all trip reports and related information Assists in development and ongoing maintenance of the Quality Management Plan (QMP), documenting approved approaches for quality assurance, quality control, and continuous improvement Conducts periodic quality control and assurance audits of contract deliverables and processes Monitors and controls quality activities as outlined in the QMP Measures and tracks contract performance objectives, maintaining a comprehensive repository of metrics Gathers and prepares performance feedback for subcontractors to be input into the CACI Procure to Pay (P2P) system and Subcontractor Performance Scorecard Suggests improvements to enhance overall quality Collaborates with the CACI Operational Excellence Team to coordinate and support Excellence+ reviews, contributing to the continuous improvement of program operations Supports technical working groups and program deliverables (such as the PMP) as needed Possesses and applies expertise on multiple complex work assignments Operates with appreciable latitude in developing methodology and presenting solutions to problems Required Skills: Current Secret Clearance with eligibility to obtain TS is required Requires expert knowledge of and ability to apply advanced technical principles, theories, and concepts Demonstrated ability for oral and written communication with the highest levels of management and delivery of required reports in accordance with formal contractual agreements. Experience executing process improvement for large scale programs. BS degree and 8-12 years of relevant experience or Masters with 6-10 years relevant experience. ____ What You Can Expect: A culture of integrity. At CACI, we place character and innovation at the center of everything we do. As a valued team member, you'll be part of a high-performing group dedicated to our customer's missions and driven by a higher purpose - to ensure the safety of our nation. An environment of trust. CACI values the unique contributions that every employee brings to our company and our customers - every day. You'll have the autonomy to take the time you need through a unique flexible time off benefit and have access to robust learning resources to make your ambitions a reality. A focus on continuous growth. Together, we will advance our nation's most critical missions, build on our lengthy track record of business success, and find opportunities to break new ground - in your career and in our legacy. Your potential is limitless. So is ours. Learn more about CACI here. ____ Pay Range: There are a host of factors that can influence final salary including, but not limited to, geographic location, Federal Government contract labor categories and contract wage rates, relevant prior work experience, specific skills and competencies, education, and certifications. Our employees value the flexibility at CACI that allows them to balance quality work and their personal lives. We offer competitive compensation, benefits and learning and development opportunities. Our broad and competitive mix of benefits options is designed to support and protect employees and their families. At CACI, you will receive comprehensive benefits such as; healthcare, wellness, financial, retirement, family support, continuing education, and time off benefits. Learn more here. The proposed salary range for this position is: $62,200-$130,600 CACI is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, age, national origin, disability, status as a protected veteran, or any other protected characteristic.

Posted 30+ days ago

ATC Sme/Qa Analyst (Csa, On-Site)-logo
ATC Sme/Qa Analyst (Csa, On-Site)
CSSI, Inc.Fort Worth, TX
Responsibilities: Review and validation of Mandatory Occurrence Reports (MORs). Investigates surface incidents including runway incursions, vehicle/pedestrian deviations, pilot deviations, ATC loss of separation. As appropriate conducts interviews of pilots. Completes required preliminary reporting forms, i.e., FAA Form 8020-17, for various incidents. Creates replays and retrieves voice recordings to assist in investigation, research, and review of incidents. As requested by the QA Manager prepares reports to support and communicate program status. Communicates with FAA Facilities and other program offices. Purpose of communication is to provide assistance to field facilities concerning QA/QC and Runway Safety issues and share information with other program offices. Contacts field facilities to request information that cannot be obtained through other methods. Minimum Qualifications: Bachelor's degree in math, engineering, or science plus a minimum of 15 years ATC experience in a LVL 8 or higher FAA/military equivalent ATC facility. Educational Requirement: In lieu of an applicable bachelor's degree eight (8) years of relevant experience may be substituted Candidate must able to work out of the Central Service Area (Forth Worth, TX office) on a full time basis. Desired Qualifications: Experience as a QA/QC specialist or manager in a field ATC facility, District, Service Center/Service Area office, or at FAA Headquarters About CSSI: CSSI, LLC., has 30 years of experience working in complex, dynamic, safety critical systems supporting both government and commercial clients to address their toughest challenges, with efficient and low-risk solutions. Our collaborative work has improved the safety of transportation related human and systems infrastructure, increased the efficiency of the National Airspace System (NAS), and facilitated the modernization of both NAS and DoD systems and capabilities. Founded in 1990 and headquartered in Washington, D.C., CSSI employs nearly 200 employees throughout the country, helping customers across the United States and globally understand and implement the solutions to their biggest obstacles. For more information on CSSI, please visit www.cssiinc.com.

Posted today

Manager, QA Manufacturing Compliance, Hopewell Site-logo
Manager, QA Manufacturing Compliance, Hopewell Site
Beigene, Ltd. ApacHopewell, VA
BeiGene, Ltd. has proposed to change its name to BeOne Medicines Ltd. The new name is subject to shareholder approval and, once approved, use of the name will be phased in over 2025. There may be instances where "BeiGene" or "BeOne" are used to describe the company during this transition period. BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General Description: Supports QA investigation activities, ensuring the successful day to day management of: Deviations, root cause analysis, CAPA's, effectiveness checks, internal and external customer complaints, and related support activities. Works to support QA Key Performance Indicators (KPIs) such as SOP mandated cycle times, on time closure dates, and QA objectives, whilst adhering to regulatory compliance and achieving business success. Work to support both internal GMP audits and Health Authority audits. Supports QA Manufacturing related tasks as assigned by QA Management.to ensure the efficient and effective day to day running of the QA Manufacturing Team. Essential Functions of the job: Ensures the development of Manufacturing QA and Compliance SOPs (writing, revising and approving), ensuring regulatory compliance in conjunction with being 'fit for purpose' operationally and commercially. Supports QA manufacturing shop floor activities with resources as needed. Support all QA shop floor and batch systems to ensure compliance with FDA/EU regulations, covering cGMP for commercial medicinal products and clinical material for human use. Significant participation in regulatory and customer inspections/audits. Significant knowledge in GMPs: CFR 210, 211, and 600; knowledgeable in EU Advanced Therapy Medicinal Products (ATMPs). Ensures all activities are performed in accordance with GMPs, SOPs and Health and Safety policies. Maintaining an awareness of new and proposed legislation that impacts the business and communicating any changes to the Senior Management Team. Ensuring that the QA batch release function and Deviation and CAPA processes meet or improve key performance indicators (KPIs). Supervises direct reports, to ensure compliance with business procedures and GMP's Ensuring appropriate investigation of discrepancies, errors, complaints, failures, or adverse events requiring documented review and action. Undertaking any other duties for any department within the business, which may be requested by the QA Department Head, for which training and/or an explanation has been provided and the scope of work is understood. Core Competencies, Knowledge, and Skill Requirements Scientific degree (ideally biotechnology, biology, pharmacy, pharmaceutical sciences, chemistry or related scientific field). Minimum of 5+ years of experience in biological quality assurance, preferably with advanced knowledge of large molecule manufacturing in an FDA-regulated biotechnology or pharmaceutical company with progressive levels of responsibility required. Minimum of 2-5 years of experience in people management, knowledge of cGMP and Data Integrity Guidance utilized in a manufacturing operations environment. Demonstrable track record and skills/experience gained within a similar position(s), at a similar level. Working knowledge of cGMPs: 21CFR parts 2010 & 211, knowledge of 21CFR600 - Biologics desirable. Wide knowledge of products and processes used in the manufacture of unlicensed medicines (clinical materials, mfd. under and IND or IMP). Knowledge of commercial BLA products. Strong personal leadership skills and experience, ability to lead small teams. Good communicator (written and verbal) and strategic thinker, highly customer focused. Strong analytical and problem-solving ability. Strong project management skills. Hands-on approach, with a 'can do' attitude. Ability to prioritize, demonstrating good time management skills. Excellent attention to detail, with the ability to work accurately in a busy and demanding environment. Self-motivated, with the ability to work proactively using own initiative. Committed to learning and development. Highly Desirable: Good IT skills e.g., Microsoft Office (Word, Excel, PowerPoint, Project and Outlook) Significant Contacts Interacts with BeOne employees in all departments; CMOs. Supervisory Responsibilities: Supervises direct reports within the Manufacturing QA and Compliance Team, assists with batch review and release as necessary. QA, Mfg. shop floor QA oversight. Works to ensure that QA Compliance requirements are adequate and meet global standards. Computer Skills: Strong PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint). Ability to work on a computer for extended periods of time Other Qualifications: Ed ucation Required: Bachelor of Science Degree (or above) in a related scientific discipline Must be able to work in the US without corporate sponsorship. Travel: Ability to travel approximately10%; Requires a valid passport. Global Competencies When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity Salary Range: $104,600.00 - $144,600.00 annually BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeiGene, Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness. We are proud to be an equal opportunity employer and we value diversity. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

Posted 30+ days ago

QA Coordinator-logo
QA Coordinator
AviagenLongview, TX
Job Description Summary: We are seeking an outstanding individual to fill the position of Quality Assurance Coordinator at Aviagen's Hatchery in Longview, TX. This role will primarily be responsible for verification of production processes, and monitoring of operational sanitation and plays a critical part of the hatchery team to ensure Aviagen's quality objectives are maintained and improved upon. The position will report directly to the Operations Manager. Job Description: The ideal candidate should have the following experience, skills, and attributes: Strong computer skills including Microsoft Excel (with Pivot Tables), PowerPoint, and Word. Able to work flexible hours. Typical work week is Monday - Friday. Must be able to perform occasional physically demanding aspects of the job. Bachelors of Science or equivalent. Ability to problem solve and think critically. Detail oriented, professional, strong organizational skills, and self-motivated. Preferred understanding of ISO 9001:2015 or equivalent. Preferred knowledge of hatchery operations or the poultry industry. The following duties will vary according to the needs of the organization. Normal duties will include, but are not limited to, the following: Quality Assurance checks on day old chicks and eggs. Observe and ask employees questions pertaining to job functions. Read processing information such as work instructions, worker logs, product processing sheets, and specification sheets to verify that records adhere to quality assurance specification. Aptitude to determine appropriate corrective actions and root cause analysis. Perform routine facility monitoring and sample collection. Interact and communicate with all levels of facility personnel. Write and submit reports to facility management and QA management team. Identify and rectify quality issues in the facility. Maintain and upload paperwork in a timely manner. Other duties as determine by the QA Management team. We offer: Affordable health insurance 401K PTO Paid holidays Bonus plan We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Posted 30+ days ago

Lead Construction Qa/Qc - Disaster Recovery-logo
Lead Construction Qa/Qc - Disaster Recovery
ICF International, IncTallahassee, FL
Join the ICF team and make a difference! Our growing Disaster Management Division makes BIG things happen every day. ICF is seeking a Construction QA/QC Lead to assist the State of Florida with managing federal disaster recovery grant programs and carrying out strategic, high-impact activities to rebuild housing, strengthen communities, and mitigate future disaster risks. The right candidate will have experience in the U.S. Department of Housing and Urban Development's (HUD) Community Development Block Grant (CDBG), Community Development Block Grant- Disaster Recovery (CDBG-DR), and Community Development Block Grant- Mitigation (CDBG-MIT) programs, as well as an understanding of other federal disaster recovery programs and applicable cross-cutting requirements. You will work with other senior staff, subject matter experts, and junior staff to quality assure all construction documentation, develop and deliver training and technical assistance, and support all construction-related activities in Florida's disaster recovery and mitigation efforts. This position requires flexibility, critical thinking, and the ability to adjust to an ever-changing environment. Key Responsibilities: Work as part of a team providing expert services to support disaster recovery and mitigation efforts, focusing on QA/QC of construction activities. Manage a team of QA/QC specialists. Ensure quality and accuracy of inspections, cost estimations, scopes of work, builder invoices, cost reasonableness determinations, and environmental requirements (lead-based paint, asbestos, mold, Section 106 compliance). Review inspector and builder change order requests for reasonableness and necessity. Review and verify milestone inspection documentation for completeness, accuracy, and consistency with the approved project scope. Ensure all required programmatic documentation is accurately supplied and entered into the system of record. Review builder assignment methodologies, builder performance scoring, and contractor compliance with program standards. Assist with the development and refinement of QA/QC policies, procedures, and processes for implementation and training. Support field teams and provide operational guidance on quality assurance best practices. Other tasks, as assigned. Minimum Qualifications: Bachelor's degree in Construction Management, Engineering, Architecture, or a related field (or 3 years of experience with CDBG-DR construction programs in lieu of a degree). 2+ years of experience supporting CDBG-DR or CDBG-MIT housing recovery construction programs. Proficiency with Xactimate X or later versions as it relates to CDBG-DR construction, damage assessments, and cost estimates. Knowledge of IRC 2021, IBC 2021, Florida Building Code, and residential construction and resilient building practices. Proficiency in Microsoft Excel, including use of advanced formulas, charts, and formatting to create client-ready deliverables. Ability to manage multiple people and projects, and tasks simultaneously in a fast-paced environment. Strong attention to detail, communication, and problem-solving skills. Ability to work independently or collaboratively as part of a multidisciplinary team. Other Job Details: Remote position with possible travel to client sites and field offices throughout Florida. Full-time position. Working at ICF ICF is a global advisory and technology services provider, but we're not your typical consultants. We combine unmatched expertise with cutting-edge technology to help clients solve their most complex challenges, navigate change, and shape the future. We can only solve the world's toughest challenges by building a workplace that allows everyone to thrive. We are an equal opportunity employer. Together, our employees are empowered to share their expertise and collaborate with others to achieve personal and professional goals. For more information, please read our EEO policy. Reasonable Accommodations are available, including, but not limited to, for disabled veterans, individuals with disabilities, and individuals with sincerely held religious beliefs, in all phases of the application and employment process. To request an accommodation, please email Candidateaccommodation@icf.com and we will be happy to assist. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodations. Read more about workplace discrimination rights or our benefit offerings which are included in the Transparency in (Benefits) Coverage Act. Candidate AI Usage Policy At ICF, we are committed to ensuring a fair interview process for all candidates based on their own skills and knowledge. As part of this commitment, the use of artificial intelligence (AI) tools to generate or assist with responses during interviews (whether in-person or virtual) is not permitted. This policy is in place to maintain the integrity and authenticity of the interview process. However, we understand that some candidates may require accommodation that involves the use of AI. If such an accommodation is needed, candidates are instructed to contact us in advance at candidateaccommodation@icf.com. We are dedicated to providing the necessary support to ensure that all candidates have an equal opportunity to succeed. Pay Range- There are multiple factors that are considered in determining final pay for a position, including, but not limited to, relevant work experience, skills, certifications and competencies that align to the specified role, geographic location, education and certifications as well as contract provisions regarding labor categories that are specific to the position. The pay range for this position based on full-time employment is: $80,708.00 - $137,203.00 Florida Remote Office (FL99)

Posted 30+ days ago

Mechanical Document Reviewer (Mep) - QA /QC-logo
Mechanical Document Reviewer (Mep) - QA /QC
Gilbane Building CompanyProvidence, RI
Overview Are you looking for a highly rewarding opportunity that provides extensive career growth opportunity? Gilbane is seeking an IDC Reviewer II to perform all discipline review functions on assigned projects and is responsible for one or more discipline reviews. The IDC Reviewer II has the ability to complete all IDC checklist steps independently for select discipline(s), may mentor team members, and works under the supervision of the IDC Manager or Senior IDC Manager. Who are we? As a Top-10 ENR Contractor, Gilbane is a family-owned business with 45 offices that has been shaping communities since 1870. Consistently recognized as one of the most reputable construction management firms in the country, Gilbane is committed to delivering projects safely and on-time. You will have the opportunity to build schools, labs, hospitals, corporate offices, sports arenas and more! We are dedicated to building a diverse, inclusive and authentic workplace, so if you're excited about this role but your past experience doesn't align perfectly with every qualification in the job description, we encourage you to apply anyway. You may be just the right candidate for this or other roles. Who are you? You are someone who acts inclusively, showing empathy and treating others with respect and dignity in order to uphold Gilbane's core value of Caring and "People First" workplace culture. You seek to listen in order to understand and can convey information clearly. You're a strong problem solver who can identify, prioritize, and implement alternatives for solutions, and you demonstrate adaptability by collaborating with others and supporting team members to achieve excellence. A self-starter who shows passion, commitment, and ownership all while delivering on business outcomes and driving results. You're someone who identifies opportunities for new and improved ways of doing things that result in value-add solutions. Your core values match Gilbane's: Integrity, Caring, Teamwork, Toughmindedness, Dedication to Excellence, Discipline, Loyalty, and Entrepreneurship. What's in it for you? Gilbane offers employees multi-dimensional training opportunities through a number of resources. While managing your responsibilities to projects, you will be able to enroll in trainings through our award-winning Gilbane University to build leadership and technical skills. In addition, you would work with an experienced team which provides you with the opportunity to learn new industry skills every day. You will protect and promote the interests of both Gilbane and the client in all matters as well as demonstrating the personal characteristics of a developing leader. This role offers flexibility in location to accommodate the right candidate. Responsibilities Understands and executes IDC checklist items for specific discipline(s) Creates Coordination Issues in Procore that highlight missing items or items that aren't coordinated Completes all IDC checklist tasks for a specific discipline(s) in a professional manner with minimal direction Contributes to IDC Policies and Procedures Qualifications EXPERIENCE/EDUCATION Bachelor's degree in Architecture or Engineering preferred 3+ years of experience in the construction field, in a design environment, or in a related field Or equivalent combination of education and experience KNOWLEDGE, SKILLS & ABILITIES Ability to read and understand construction documents and specifications Ability to investigate cross discipline coordination issues Strong verbal and written communication skills Strong attention to detail and quality skills Ability to work and partner with others on the IDC team, design partners, and client partners Ability to be self-disciplined and flexible by changing assignments as workload priorities change Knowledge of construction means and methods Knowledge of the following software is preferred but not required: Procore & Bluebeam Strong time management and organization skills Strong computer skills within Microsoft Office Suite and IDC software Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data. This salary range for this role is $63,000-$100,100 plus benefits and retirement program. This role offers flexibility in location to accommodate the right candidate. Gilbane offers an excellent total compensation package which includes competitive health and welfare benefits and a generous profit-sharing/401k plan. We invest in our employees' education and have built Gilbane University into a top training organization in the construction industry. Qualified applicants who are offered a position must pass a pre-employment substance abuse test. Gilbane is an Affirmative Action/Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to age, color, national origin, race, religion, sex, sexual orientation, gender identity, protected veteran status, or disability status. Note to Recruiters, Placement Agencies, and Similar Organizations: Gilbane does not accept unsolicited resumes from agencies. Please do not forward unsolicited agency resumes to our jobs alias, website, or to any Gilbane employee. Gilbane will not pay fees to any third party agency or firm and will not be responsible for any agency fees associated with unsolicited resumes. Unsolicited resumes received will be considered property of Gilbane and will be processed accordingly.

Posted 30+ days ago

Senior QA Automation Engineer-logo
Senior QA Automation Engineer
Ryko Solutions IncAtlanta, GA
"High-Fiver" Wanted: Senior QA Automation Engineer This position requires the candidate to be available to work in-person in our Atlanta office. We are in the office 3 days per week, but support flexibility as needed. We are not currently able to sponsor work visas now or in the future. In this role, you will design, develop, and maintain robust automated testing frameworks and solutions that ensure the quality of our products across web, mobile, and API platforms. Key Responsibilities include: Test Automation Development Design, develop, and maintain scalable automated test frameworks from the ground up Create comprehensive automated test suites across UI, API, and mobile platforms Implement continuous integration testing within our CI/CD pipeline Develop reusable, modular, and maintainable test code that follows best practices Troubleshoot and resolve complex automation issues Technical Leadership Mentor junior automation engineers and manual testers transitioning to automation Research and recommend new tools and technologies to improve our testing capabilities Optimize test execution speed and reliability Configure and maintain testing environments Document automation best practices and testing standards Testing Strategy Create detailed test scenarios and test cases for critical features and functionality Identify opportunities to transition manual tests to automated solutions Develop data-driven testing approaches to maximize test coverage Implement performance, load, and security testing when appropriate Quality Assurance Participate in requirement reviews to ensure testability Analyze test results and provide detailed, actionable feedback to development teams Track and report on automation coverage and effectiveness Participate in release readiness assessments and quality gate reviews Required Qualifications 4+ years of experience in test automation development Strong programming skills in one or more languages (we currently use C# and MSTest) Proven experience with test automation frameworks (Selenium, Cypress, Playwright, or Appium) Experience testing across multiple platforms (web, mobile, API) Strong understanding of automation best practices, including patterns like Page Object Model Familiarity with CI/CD tools (Jenkins, GitHub Actions, Azure DevOps) Experience with version control systems (Git) Excellent problem-solving and debugging skills Knowledge of Agile methodologies and software development lifecycle Bonus Points and Street Cred for Bachelor's degree in Computer Science, Engineering, or related field Experience with BDD frameworks (Cucumber, SpecFlow) Mobile testing automation experience with Appium or similar tools API testing experience with Postman, RestAssured, or similar tools Experience with performance testing tools (JMeter, Gatling) Knowledge of containerization technologies (Docker, Kubernetes) Experience with cloud testing platforms (BrowserStack, Sauce Labs) Contributions to open-source testing projects Testing certifications (ISTQB, etc.) About AMP (An NCS Company) We are a rapidly growing technology company based in Atlanta. Our marquis product, AMP Memberships, is a membership and loyalty platform for carwashes. Since we officially launched AMP, it has taken off like a rocket ship and is now active or coming soon at over 700 car wash locations. Our platform includes mobile and tablet apps, kiosks, web apps, and data and analytics. We are technology agnostic and leverage modern frameworks and cloud infrastructure such as React, React Native, Azure, AWS, Snowflake, NodeJS, .NET, and more. AMP is a division of National Carwash Solutions (NCS). NCS has grown to become North America's largest equipment, service, and cleaning solutions provider in the car wash industry. Our world-class brands are backed by the largest service network in the country, with more than 500 dedicated service professionals and growing! Why Work for Us? We have one of the most supportive and sustainable cultures anywhere. Our team of lifelong learners has a thirst for knowledge and passion for technology and software. We're dedicated to building world-class solutions for our customers and at the same time place a high value on team rewards and personal career growth. We enjoy working together to solve challenging problems, teaching each other through lunch-and-learns, and celebrating victories (even the small ones) along the way. Benefits You Deserve Highly competitive salaries Potential equity interest in a rapidly growing company 401K plan with company matching Excellent medical, dental, and vision insurance But Wait, There's More! Located at Atlanta Tech Village, the 4th largest tech space in the US World-class engineering team with an incredible track record Team-building events, outings, and hackathons State-of-the-art workspace and hardware Strong focus on community service and volunteering Free gym, snacks, and beverages National Carwash Solutions is a proud equal opportunity employer. We are a drug free, EEO employer committed to a diverse workforce. We will consider all qualified candidates regardless of race, color, national origin, sex age, marital status, personal appearance, sexual orientation, gender identity, family responsibilities, disability, education, political affiliation or veteran status.

Posted 30+ days ago

ATC Sme/Qa Analyst (Esa, On-Site)-logo
ATC Sme/Qa Analyst (Esa, On-Site)
CSSI, Inc.College Park, GA
Responsibilities: Review and validation of Mandatory Occurrence Reports (MORs). Investigates surface incidents including runway incursions, vehicle/pedestrian deviations, pilot deviations, ATC loss of separation. As appropriate conducts interviews of pilots. Completes required preliminary reporting forms, i.e., FAA Form 8020-17, for various incidents. Creates replays and retrieves voice recordings to assist in investigation, research, and review of incidents. As requested by the QA Manager prepares reports to support and communicate program status. Communicates with FAA Facilities and other program offices. Purpose of communication is to provide assistance to field facilities concerning QA/QC and Runway Safety issues and share information with other program offices. Contacts field facilities to request information that cannot be obtained through other methods. Minimum Qualifications: Bachelor's degree in math, engineering, or science plus a minimum of 15 years ATC experience in a LVL 8 or higher FAA/military equivalent ATC facility. Educational Requirement: In lieu of an applicable bachelor's degree eight (8) years of relevant experience may be substituted Candidate must able to work out of the Eastern Service Area on a full time basis. Desired Qualifications: Experience as a QA/QC specialist or manager in a field ATC facility, District, Service Center/Service Area office, or at FAA Headquarters About CSSI: CSSI, LLC. has 30 years of experience working in complex, dynamic, safety critical systems supporting both government and commercial clients to address their toughest challenges, with efficient and low-risk solutions. Our collaborative work has improved the safety of transportation related human and systems infrastructure, increased the efficiency of the National Airspace System (NAS), and facilitated the modernization of both NAS and DoD systems and capabilities. Founded in 1990 and headquartered in Washington, D.C., CSSI employs nearly 200 employees throughout the country, helping customers across the United States and globally understand and implement the solutions to their biggest obstacles. For more information on CSSI, please visit www.cssiinc.com.

Posted today

Senior QA Engineer-logo
Senior QA Engineer
KandjiMiami, FL
About Kandji Kandji is the Apple device management and security platform that empowers secure and productive global work. With Kandji, Apple devices transform themselves into enterprise-ready endpoints, with all the right apps, settings, and security systems in place. Through advanced automation and thoughtful experiences, we're bringing much-needed harmony to the way IT, InfoSec, and Apple device users work today and tomorrow. Some of the smartest money in tech has partnered with Kandji to realize our vision, including Tiger Global, Felicis, Greycroft, First Round Capital, and Okta Ventures. In July 2024, Kandji raised $100 million in capital from General Catalyst, bringing Kandji's valuation to $850 Million. Since Kandji's Series C in 2021, the company has seen a 600%+ increase in annual recurring revenue, and its customer base has grown nearly 4X across 40+ industries. Notable customers include Allbirds, Canva, and Notion, and the company has partnerships with such industry giants as ServiceNow, AWS, and Okta. Kandji was also named to Forbes' Next Billion Dollar Startup List 2023 and recognized as a top venture-backed startup with the potential to reach unicorn status. The Opportunity: Kandji is looking for an experienced Sr. Quality Assurance Test Engineer to join our growing team! As a Sr. QA Test Engineer, you will be embedded on one of our development teams, where you will own all of the manual and automated testing requirements for that product area. We are looking for testers who can exhibit a high degree of ownership, passion, and communication to bring our team to the next level. How you'll make a difference day to day: Manage, drive, and own the entire testing process for your development team Develop, maintain, and execute comprehensive test strategies, test plans, test cases, swarm test sessions, and test procedures Perform function, integration, regression, exploratory, automated and end-to-end testing Reproduce, diagnose, and document software defects with clarity and precision Play a key role in early product development discussions to ideate, review, and catch potential issues before code is written We'd love to hear from you if you have: 4+ years of experience in a software testing role Exceptional knowledge of QA fundamentals and best practices: test strategies, test planning, test execution, defect management, reporting, etc. Excellent time management, organization, communication, and problem-solving skills Exposure to Agile development environments and associated scrum activities, such as planning, grooming, retrospective, etc. Experience with Playwright, Appium, or other automated test frameworks Required to work on-site 5x a week in our Miami office (Coral Gables). Nice to have, but not required: Direct experience testing for growth/onboarding teams 8+ years in a software testing role Experience with issue tracking systems, such as Jira, Rally, Trello, etc. Experience with test case management systems, such as TestRail, qTest, Zephyr, etc. Extensive hands-on experience testing or managing the deployment of devices, software, and services Significant knowledge in the areas of device management and software integration within an enterprise setting, including printers, WiFi, directory services, Kerberos, SSO, etc. Fluency with shell scripting, Python, Typescript and/or the macOS command line Comfortable using terminal to execute commands, run scripts, etc. Extensive knowledge of the MDM space Ability to test API requests via Postman or other similar tools Experience running, managing, and deploying test infrastructure Benefits & Perks Competitive salary 100% individual and dependent medical + dental + vision coverage 401(k) with a 4% company match 20 days PTO Kandji Wellness Week the first week in July Equity for full-time employees Up to 16 weeks of paid leave for new parents Paid Family and Medical Leave Modern Health- Mental Health Benefits- Individual and Dependents Fertility Benefits Working Advantage Employee Discounts Free onsite fitness center Free parking Lunch 5 days/week Exciting opportunities for career growth An outstanding, inclusive culture We are excited to be serving a significant need for a fast-growing market, and are proud of the high-performing team we have brought together so far. If you're someone who wants to engage in new, exciting projects that will challenge your skills in the best way possible, we would love to connect with you. At Kandji we believe in fostering an inclusive environment in which employees feel encouraged to share their unique perspectives, leverage their strengths, and act authentically. We know that diverse teams are strong teams, and welcome those from all backgrounds and varying experiences. Kandji is proud to be an equal opportunity employer committed to diversity and inclusion in the workplace. Qualified applicants will be considered for employment without regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, physical or mental disability, protected veteran or military status or any other status protected by applicable law.

Posted 5 days ago

Manager, QA Automation-logo
Manager, QA Automation
Stryker CorporationSan Diego, CA
Work Flexibility: Hybrid Why Engineering at Stryker? At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker, you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better. Here, you will work in a supportive culture with other incredibly talented and intelligent people, creating industry-leading medical technology products. You will also have growth opportunities as we have a culture that supports your personal and professional development. Need another reason to apply? Check out these 8 reasons to join Stryker's engineering team: https://www.strykercareersblog.com/post/8-reasons-to-join-strykers-engineering-team Stryker is seeking a QA Automation Manager to lead the Edge Clinical Workflow QA automation team. In this role, you will lead a team of SDETs and be responsible for building a best-in-class automation function supporting the Edge Clinical Workflow Platform. What You Will Do Lead a team of SDETs who work closely with our Development, QA and Systems teams to deliver high-quality, resilient software solutions that meet the stringent requirements of the healthcare industry. Responsible for developing, implementing and executing on a comprehensive test automation strategy, driving continuous improvement in our testing processes, and ensuring compliance with regulatory standards. Partner with cross functional teams to ensure seamless integration of automation into the software development lifecycle. Stay up to date with the latest trends and technologies in test automation and quality assurance. Measure and enhance test automation coverage and reduce test execution time. Establish and track key performance metrics to measure automation adoption and effectiveness. Implement governance policies to ensure high-quality test coverage and maintainability. Identify bottlenecks and inefficiencies in testing workflows and drive continuous improvement. What You Need Required Qualifications Bachelor's degree in computer science, Engineering, or a related field. 8+ years of overall experience in technology. 2+ years of hands-on experience with automation frameworks and one or more programming languages. Minimum of 2+ years of experience managing high performing teams. Preferred Qualifications Strong track record of building and managing high performing teams, with demonstrated experience in software automation. Experience with test automation frameworks for distributed systems, backend APIs, and microservices (Selenium, Playwright, Cypress, Pytest or other). Experience with Kotest a strong plus. Hands-on experience in one or more programming languages (Java, Python or Kotlin) Knowledge of one or more leading Cloud platforms (AWS Preferred) and CI/CD tools such as Jenkins, Azure DevOps, or equivalent. Knowledge of API testing using Postman and Postman collections. Proficiency in using TestRail for test case management and reporting. Familiarity with Jira for issue tracking, reporting, and sprint planning within SAFe Agile processes. Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Travel Percentage: None Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability. Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.

Posted 2 days ago

Manual QA Engineer-logo
Manual QA Engineer
Fortune Media IP LimitedNew York, NY
Manual QA Engineer At Fortune Media, we are reinventing how a storied brand, steeped in journalism and business, adapts to today's digital-first world. The digital transformation of Fortune from a print magazine to a multi-channel media company is in full swing, and we want you to be a part of it. The Engineering team works on multiple digital properties at Fortune: from the editorial website, conferences, Fortune Recommends and others. Our goal is to launch new products to build on our core competencies of content, events and education, in order to diversify our revenue streams; and to improve the experience and monetization of existing properties. We are seeking a highly motivated and detail-oriented Manual QA Engineer to join our dynamic engineering team. In this role, you will be a critical contributor to ensuring the quality and reliability of our cutting-edge applications. You will work closely with product managers and engineers in a fast-paced environment, participating in product and engineering meetings to gain a deep understanding of requirements and providing immediate feedback through ad-hoc testing. While we heavily leverage e2e automation for regression, your expertise in manual testing, particularly for new features and exploratory testing, will be invaluable. You will be responsible for creating comprehensive test cases, identifying and documenting defects, and championing a superior user experience across both mobile and desktop platforms. Responsibilities: Product Understanding and Collaboration: Actively participate in product meetings, sprint planning, and daily stand-ups to understand requirements and provide QA input early in the development lifecycle. Collaborate closely with product managers and engineers to clarify requirements and ensure testability. Ad-Hoc and Feature Testing: Perform ad-hoc testing of features during development to provide immediate feedback to engineers. Execute thorough manual testing of new features in QA branches with code freeze, ensuring they meet functional and non-functional requirements. Test Case Creation and Execution: Develop comprehensive and well-structured test cases based on product requirements and user stories. Execute test cases and document results with precision. Cross-Platform Testing: Conduct thorough testing across multiple browsers and operating systems (desktop and mobile), identifying and addressing platform-specific issues. Understand the nuances of mobile and desktop user experiences and ensure consistency. Performance and User Experience Evaluation: Assess application performance and identify potential bottlenecks. Evaluate the user experience, providing feedback on usability and accessibility. Bug Reporting and Defect Management: Identify, document, and track defects using a bug tracking system (e.g., Jira). Write clear, concise, and reproducible bug reports, including detailed steps, screenshots, and relevant logs. Work with engineers to ensure bugs are resolved in a timely manner. Quality Advocacy: Champion quality throughout the development process. Proactively identify areas for improvement in testing processes and methodologies. Qualifications: Bachelor's degree Proven experience in manual QA testing, preferably in a fast-paced agile environment. Strong understanding of software testing methodologies and best practices. Experience with cross-platform testing (desktop and mobile). Ability to create clear and comprehensive test cases and bug reports. Excellent analytical and problem-solving skills. Strong communication and collaboration skills. Understanding of web and mobile technologies. Experience with bug tracking systems such as JIRA. A passion for delivering high-quality software and a strong user focus. Preferred Qualifications: Bachelor's degree in Computer Science, Engineering, or a related field (or equivalent experience) is a plus Experience with performance testing tools. Basic understanding of automation testing concepts. Experience in a company that operates at scale. Benefits: Be a part of a world-renowned media organization with a rich history. Work on challenging projects with a significant impact on a global audience. Collaborate with a talented and passionate team. Opportunities for professional growth and development. If you are a passionate software engineer who thrives in a fast-paced environment and is eager to contribute to the future of digital media, we encourage you to apply! Total Compensation Ranges (base salary & bonus): $50k-$80k About Fortune: At Fortune Media, our mission is to change the world by making business better. We achieve that by providing trusted information, great storytelling, rigorous benchmarking and world-class community building. And our key values are humility, ownership, and transparency. The policy of Fortune Media is to provide equal employment opportunities to all applicants and employees without regard to race, color, caste, creed, religion, sex, sexual orientation, gender identity or expression, marital status, citizenship status, age, national origin, ancestry, disability, or any other characteristic protected by applicable law. Fortune Media affirmatively seeks to advance the principles of equal employment opportunity and values diversity and inclusion. FORTUNE Fortune Media is a global media organization dedicated to helping its readers, viewers, and attendees succeed in business through unrivaled access and best-in-class storytelling. Fortune's mission is to drive the conversation about business. With a global perspective, the guiding wisdom of history, and an unflinching eye to the future, we report and reveal the stories that matter today-and that will matter even more tomorrow. With the trusted power to convene and challenge those who are shaping industry, commerce and society around the world, Fortune lights the path for global leaders-and gives them the tools to make business better. Our values inform our mission. We believe that business can be a powerful platform for good, and we are committed to holding it to that standard. boards.greenhouse.io For Residents of California: Our California Resident Applicant and Prospective Applicant Privacy Notice is located at this link: https://fortune.com/california-resident-applicant-and-prospective-applicant-privacy-notice/ For UK, EEA, and Switzerland Residents: Please review Fortune Media Group (UK) Limited's Job Applicant Privacy Notice at https://fortune.com/job-applicant-privacy-notice-uk/ to understand how your personal data will be handled.

Posted 30+ days ago

QA Engineer - Electrical-logo
QA Engineer - Electrical
Wilcox IndustriesNewington, NH
Wilcox Industries is looking for passion people who are excited to enable warfighters with leading edge tactical solutions. We currently have an opening for a full-time Quality Assurance Engineer (QE). This is an on-site position. This position is responsible for guiding efforts to identify and manage risks that could adversely affect plant or manufacturing business operations. This broad primary role includes loss elimination, risk management, and life cycle management. Roles and Responsibilities Support the Quality Management Systems. Formulates or helps to formulate Quality Assurance policies and procedures. Perform internal audits, generate audit reports, and communicate results. Designs and evaluates quality assurance processes, sampling systems, procedures, and statistical techniques. Works with Engineering on new products development to establish standards, testing and acceptance criteria. Designs or specifies inspection and testing mechanisms and equipment; analyzes production and service limitations and standards. Conducts training on quality assurance concepts, and tools. Evaluates, recommends, and facilitates lean activities for process improvement. Collects, organizes, monitors, and distributes information related to quality and process improvement functions, including but not limited to compliance to and documentation of quality management standards. Generates and analyze reports; distributes those reports to various users in the organization, customers and/or suppliers. Perform other duties as necessary when directed to do so to support business needs. Qualifications and Requirements Bachelor's Degree in Science or related work experience plus 2+ years' experience in quality, production management, engineering, or operations or a combination of education and experience. Background in Defense Industry a plus. Regular on-site attendance is a necessary function of this position. Ability to develop and manage good working relationships with internal departments (production, sales, logistics, accounting), contractors, suppliers inspectors and customers. Experience with ISO 9100: 2015 a plus Strong written and verbal communication skills. High attention to detail and excellent time management skills. Ability to identify issues and provide recommendations. Ability to work independently and as part of a team. Meet daily, weekly and monthly deadlines. Compensation offered may vary depending upon job-related knowledge, skills, and experience. Wilcox provides equal employment opportunity to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities LINKED

Posted 30+ days ago

QA Testing Analyst Sr-logo
QA Testing Analyst Sr
Huntington Bancshares IncColumbus, OH
Description Responsible for the planning, integration, casing, scripting and execution of all testing for complex call center systems. Responsible for work on multiple programs/systems as a project team member; considered to be a subject matter expert for a single program/system. These projects are of moderate to high complexity within one or more development environments. Responsible for ensuring technical quality with new and existing implementations Responsible for ensuring customer quality with new and existing implementations Responsible for continuous process improvement and analysis in current environment Responsible for analyzing current performance metrics, testing, and recommending improvements Responsible for ensuring quality controls are adhered to (PCI, customer data, masking, logging, etc.) Responsible for measuring and maintaining call center performance from an IT & business perspective (capacity, call failures, IVR utilization, etc.) Basic Qualifications Bachelor's degree 7+ years of testing experience 2 + years call center experience Preferred Qualifications Experience with Cyara testing tool Cisco certification Spanish language proficiency Negotiation skills with the ability to influence others by information/knowledge sharing Proficiency in using Cyara automation test suite, in addition to in depth knowledge of common testing methods, terminology and industry best practices Experience with contact center systems, including Cisco UCCE, Verint WFO Suite, Nuance natural language IVR, and VHT Callback. Genesys Cloud certification preferred. Experience with Agile collaboration systems, including Microsoft Azure DevOps (ADO) or Jira Excellent verbal and written communication skills with the ability to explain system issues clearly and concisely to all levels of management, and establish effective working relationships with our internal customers Ability to work in a fast-paced environment Experience in an Agile-Scrum environment Knowledge of data structures, data management practices, various corporate security rules, legal and regulatory obligations such as PCI, SOX or similar standards Advanced knowledge of using software packages or tools for processing or displaying data Exempt Status: (Yes = not eligible for overtime pay) (No = eligible for overtime pay) Yes Workplace Type: Office Our Approach to Office Workplace Type Certain positions outside our branch network may be eligible for a flexible work arrangement. We're combining the best of both worlds: in-office and work from home. Our approach enables our teams to deepen connections, maintain a strong community, and do their best work. Remote roles will also have the opportunity to come together in our offices for moments that matter. Specific work arrangements will be provided by the hiring team. Huntington will not sponsor applicants for this position for immigration benefits, including but not limited to assisting with obtaining work permission for F-1 students, H-1B professionals, O-1 workers, TN workers, E-3 workers, among other immigration statuses. Applicants must be currently authorized to work in the United States on a full-time basis. Huntington is an Equal Opportunity Employer. Tobacco-Free Hiring Practice: Visit Huntington's Career Web Site for more details. Note to Agency Recruiters: Huntington will not pay a fee for any placement resulting from the receipt of an unsolicited resume. All unsolicited resumes sent to any Huntington colleagues, directly or indirectly, will be considered Huntington property. Recruiting agencies must have a valid, written and fully executed Master Service Agreement and Statement of Work for consideration.

Posted 1 week ago

Midlevel QA Engineer-logo
Midlevel QA Engineer
CargomaticLong Beach, CA
Cargomatic is a technology-driven leader in the logistics and freight transportation industry, dedicated to delivering data-backed, efficient, and reliable services to our customers. As we continue to grow, we're looking for innovative team members who are passionate about leveraging data to drive financial and operational insights. Our organization was named to the list of Built in Best Places to Work for 2023, 2024, and 2025 which recognizes the benefits we offer, our people-first culture and our commitment to supporting our employees' success, growth and well-being. This is the technology platform that connects shippers and carriers in the fragmented world of short-haul trucking. We simplify logistics to keep goods moving efficiently. Join our innovative team to help shape the future of freight transportation. Position Overview: We are seeking a detail-oriented and proactive Midlevel QA Engineer to join our dynamic engineering team. The ideal candidate will have experience working in environments that leverage React and Node.js, with a focus on designing and executing test strategies to ensure the delivery of high-quality software. You'll collaborate with cross-functional teams to identify and resolve issues while improving the overall testing process. Key Responsibilities: Develop, execute, and maintain comprehensive test plans, test cases, and test scripts for React-based front-end applications and Node.js back-end services. Perform manual and automated testing across web applications, APIs, and integrated systems. Identify, document, and track software defects using bug tracking tools. Design and implement automated test scripts using tools such as Selenium, Cypress, or Playwright for React and Node.js environments. Validate API functionality using tools like Postman or RestAssured, ensuring proper integration with React front-ends. Collaborate closely with developers, product managers, and other QA team members to understand requirements and provide actionable feedback. Conduct performance and load testing to validate system reliability and scalability. Participate in sprint planning and agile ceremonies, aligning QA activities with development timelines. Contribute to the continuous improvement of QA methodologies and tools. Qualifications: Bachelor's degree in Computer Science, Engineering, or a related field (or equivalent experience). 3-5 years of experience in software quality assurance, with specific experience testing React and Node.js applications. Proficiency in using QA tools such as Selenium, Cypress, or Playwright for front-end and back-end testing. Strong understanding of RESTful APIs and experience testing them using Postman, Swagger, or similar tools. Familiarity with CI/CD pipelines and tools like Jenkins, GitHub Actions, or CircleCI. Hands-on experience with scripting languages (e.g., JavaScript, TypeScript) for test automation. Strong knowledge of the SDLC and QA best practices in agile environments. Excellent problem-solving skills, attention to detail, and communication skills. Preferred Qualifications: Familiarity with performance testing tools like JMeter or k6. Experience working in cloud environments such as AWS, Azure, or GCP. Exposure to containerization tools like Docker and orchestration with Kubernetes. Knowledge of GraphQL and testing it alongside REST APIs. The expected salary range for this role is $115,000 to $125,000. The actual base pay offered will be determined on factors such as experience, skills, training, location, certifications, education, and other factors permitted by law. Decisions will be made on a case-by-case basis. In addition to the base salary, this position may be eligible for performance-based incentives. To learn more about how we use your data, Click Here.

Posted 30+ days ago

QA Engineer (World Of Warships)-logo
QA Engineer (World Of Warships)
Wargaming AmericaBelgrade, MT
Job Overview Wargaming is looking for а QA Engineer (Core Gameplay Team) to work on World of Warships in our Belgrade office. World of Warships is the best naval game around, letting you take command of legendary warships from the period of the 20th century as you battle your way across the open sea with other players. The project is driven by a team of international developers who combine talent with their passion for video games, resulting in World of Warships being a favorite hobby for millions all around the globe with keeping its community ever-growing! What will you do? Testing game mechanics and content Design test plans to ensure the quality of the company's product Create test cases and rewrite old ones Support feature development from design documentation till release and after Collaborate with Game Designers, Developers and UI Designers on feature development What are we looking for? Commercial experience in software testing Experience with version control systems (Git, SVN) Experience with bug tracker (Jira) Experience writing and maintaining test documentation Test environment preparation skills Gaming experience and interest in games Pre-intermediate English level or higher What additional skills will help you stand out? ISTQB certificate Basic knowledge of programming Basic knowledge of SQL fundamentals Gray box testing experience Advanced Russian Work mode Onsite during probation period and hybrid mode (3 days from office) after probation period. Benefits Benefits and perks are tailored to the local market and culture. Our benefits in Belgrade include: Annual leave of 20 working days (additional days based on years of service at Wargaming: up to 25 days) Additional paid time off (5 Personal Days, Birthday Leave, Marriage Leave, Compassionate Leave) Sick Leave Compensation, Maternity Leave Benefits Premium Private Health Insurance Career development and education opportunities within the company English clubs and platform for learning languages Mental well-being program (iFeel) Commuting allowance Company events FitPass membership Discounts for employees Personal Gaming Account Coffee, fruits, and snacks in the office On-site canteen with subsidized prices for food and drinks Seniority Awards Referral program - you can recommend the best talents to the Company and receive a reward Please submit your CV in English to ensure smooth processing and review. About Wargaming Wargaming is an award-winning online game developer and publisher headquartered in Nicosia, Cyprus. Operating since 1998, Wargaming has become one of the leaders in the gaming industry with 15 offices worldwide, including studios in Chicago, Prague, Shanghai, Tokyo, and Vilnius. Our diverse and multicultural team works together to deliver a top-class experience to millions of players who enjoy Wargaming's titles across all major gaming platforms. Our flagship products include free-to-play hits World of Tanks, World of Warships and World of Tanks Blitz. Please see Wargaming Candidate Privacy Policy for details on how Wargaming uses your personal data.

Posted 1 week ago

Principal QA Automation Engineer-logo
Principal QA Automation Engineer
Rural SourcingDallas, TX
Team Sparq is committed to creating high-quality tech careers while helping clients accelerate their digital transformation journey. We are committed to being an inclusive workplace, maintaining a culture of equitable, diverse employment and advancement company-wide. C2C is not available Must be authorized to work in the U.S. without sponsorship Why you will enjoy Mondays again: Opportunity to collaborate with a diverse group of colleagues in a fun, creative environment Progressive career journey and opportunity for advancement Continuous development through training, mentorship and certification programs Exposure to modern technologies across various industries in an agile environment Ability to work in a hybrid model Competitive salary + bonus opportunities Robust benefits package, matching 401(k) plan, and substantial PTO Tuition reimbursement A Day in the Life: Design and implement automation testing strategies for SAP solutions, ensuring high-quality standards are met across all SAP modules Develop test plans and execute automated tests for SAP modules such as SAP S/4HANA, SAP FICO, SAP MM, and SAP SD Collaborate with cross-functional teams to design solutions and streamline testing processes for SAP upgrades, particularly migrations from ECC to S/4HANA Lead the Sparq QA team for the project, interfacing with client QA and management teams while directing the Sparq QA team. Review requirements and participate in architecture/design/code reviews with an emphasis on test automation strategy and adherence to coding standards Evaluate alternative technical solutions that best meet client needs and present the best option(s) Design and develop automated tests using a variety of languages (e.g. Java, C#, JavaScript), tools (e.g.Selenium, Cypress, Appium, Karate, Postman, JMeter), third party resources (e.g. BrowserStack, ReadyAPI) with a variety of test frameworks (e.g. Gherkin/BDD, TestNG, Jasmine) Create and manage Continuous Integration / Continuous Delivery environments using cloud providers (e.g. AWS, Azure) and containerized virtualization (e.g. Docker, Kubernetes) Build and maintain reusable testing infrastructure and frameworks including Mobile testing Triage failing automated tests, identifying those which truly are a defect in application code Help the development team debug application code, identifying root causes of defects Document test cases in a test management system, relating them both to the automation code and the requirements being tested What it takes: Consultative approach and problem solving skills to successfully align digital solutions with long-term business goals of the client Commitment to understanding and exceeding client expectations Ability to perform project oversight and execution of deliverables Flexibility to adapt within a high-growth organization Ability to lead, mentor and motivate those around them Hunger for continuous learning and professional development Intellectual curiosity to provide creative solutions Full understanding of the software development life cycle Ability to positively impact fellow colleagues through effective leadership, presentations, coaching, etc. Desire to work in a team environment Good interpersonal, written and verbal communication skills Equal Employment Opportunity Policy: Sparq is proud to offer equal employment opportunity without regard to age, color, disability, gender, gender identity, genetic information, marital status, military status, national origin, race, religion, sexual orientation, veteran status, or any other legally protected characteristic. #LI-HYBRID

Posted 30+ days ago

Qa/Qc Electrical Inspector-logo
Qa/Qc Electrical Inspector
Matrix Service Co.Rougemont, NC
Job Summary The QA/QC Electrical Inspector's main responsibility is to inspect, accept or reject work performed in the electrical discipline in compliance with applicable Codes and specifications. Essential Functions Actively support the Company's commitment to safety and its "Core Values." Represent the Company at all times with high moral standards while adhering to the Company's "Code of Business Conduct and Ethics." Review project specifications and work procedures to ensure inspection, testing and procedural are in compliance and aligned with Client's requirements. Perform quality audit and to verify work activities are in accordance with the approved Project Quality Plan. Regular review and update on status of quality issues. Witness and Hold point inspections of approved Inspection & Test Plans (ITPs) Witness system in supplier shop and during pre-commissioning Report non-conformities and disposition follow-up on corrective actions Monitor and surveillance of cables and cable tray routing, installation and terminations to junction boxes, panels are in compliance with the applicable codes and standards and client specifications. Monitor and verify through surveillance of EPC contractor work in electrical and instrument equipment installation, hook-up, loop checking and functional testing are in compliance with the technical requirements for the project. Monitor to ensure documentation is compiled progressively as required quality and of acceptable quality Daily surveillance reporting and submission of weekly report of work. Provide technical advice in project technical meetings on resolution of quality/construction related issues Perform additional assignments per supervisor's direction. Qualifications 3+ years' minimum experience in a specific craft or working under a formal Quality Management System. 3 years' electrical experience preferred. ACI certification preferred and other discipline specific inspection process (e.g., AWS CWI, ASNT Level II, NACE etc.) may be considered. Should be familiar with ASME Sec. VIII, Sec. IX, B31.1, B31.3, API 650/653, 1104 Codes. Strong understanding of corporate and industry practices, processes and standards and their impact on project activities. Excellent oral and written communication skills; good computer skills including MS Word and Excel. In addition, full-time employees are offered a comprehensive benefits package, including medical, dental and vision plans covering eligible employees and dependents, disability benefits, life and AD&D insurance, an employee assistance program (EAP), a 401(k) plan with company match, an employee stock purchase plan (ESPP), a robust wellness program and adoption assistance. Some employees may also be eligible for paid time off, tuition reimbursement and a performance or safety bonus program. At Matrix, we are dedicated to building a diverse, inclusive, and authentic workplace. We encourage all whose experience aligns with the listed qualifications to apply and explore joining our organization. EEO/M/F/Disability/Vets/Affirmative Action Employer We are an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, genetic information, marital status, disability, veteran status, or other legally protected characteristic or category.

Posted 30+ days ago

Structure Therapeutics Inc logo
Sr. Director, Global QA Clinical Quality Assurance
Structure Therapeutics IncSouth San Francisco, CA
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Job Description

Structure Therapeutics develops life‐changing medicines for patients using advanced structure‐based and computational drug discovery technology. The company's platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs. We are advancing a clinical‐stage pipeline of differentiated treatments focused on chronic diseases with high unmet need, including cardiovascular, metabolic, and pulmonary conditions.

Structure Therapeutics is led by an experienced group of international drug innovators and financed by top-tier global life sciences investors. The company has completed an initial public offering (IPO) in February of 2023. With offices in California and Shanghai, Structure Therapeutics has the benefit of being at the center of life science innovation in both the US and China and capitalizing on the strengths of each geographic location.

POSITION SUMMARY

The Sr. Director, Global QA Clinical Quality Assurance is responsible for development, governance, and management of GCP and ensuring other product development and PV activities comply with applicable national and international standards, regulations, and guidelines. The position will provide support and promote collaboration internally to ensure all systems, processes and their outcomes remain compliant. The position will also provide quality oversight of multiple programs in development, based on company goals.

  • Preference is for local candidates, and we are moving to a 4-day work week/in the SSF QC office
  • If remote, you will be required to work in SSF QC office one week a month

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Support the preparation and implementation of regulatory strategies, for new drug Lead Clinical Quality oversight, including creation and revision of SOPs and training programs for GCP compliance
  • Ensure involvement of Quality from early phases of development through collaboration with Clinical Science, Clinical Operations, RA, PV etc. to influence effective processes and program oversight
  • Lead in preparation and support of regulatory inspections and partner diligence audits in cooperation with multiple internal functions as well as external vendors/3rd parties. Provide training and support for inspections at sites, CROs and service providers
  • Serve as QA representative on clinical study development teams; participate in the review and approval of clinical trial "essential documents" (e.g. protocols, ICF, etc.)
  • Evaluate vendors for potential use; conduct and/or manage qualification inspections of GCP suppliers and service providers
  • Create and execute clinical study audit plans, perform routine and for-cause audits of clinical investigator sites, and review of TMFs and CSRs
  • Lead and participate in cross functional working groups to identify and mitigate GCP quality and compliance issues. Create, monitor, and improve a QMS with focus on development phases
  • Oversee GCP activities (including internal or external audit observations and development of adverse trends) in order to ensure patient safety and data integrity
  • Lead, investigate, and/or oversee quality issues including CAPAs and closures including defining and monitoring key quality metrics in support of management reviews
  • Participate in department cross-training and lead/support during regulatory inspections, serving as QA clinical expert and host inspections as needed. Assess GCP and GLP compliance risk areas and develop and implement risk mitigation measures
  • Maintain a contemporary knowledge of current agency and industry trends, standards, and methodologies as related to GCPs
  • Other duties as assigned

REQUIREMENTS

Education

  • BS/MS or equivalent in a relevant scientific discipline. Graduate level in a science or engineering related discipline preferred

Experience

  • 10 -12+ years' experience in clinical quality assurance ensuring sponsor oversight including performing GCP audits for clinical stage pharmaceutical companies with at least 5 years' experience in an out-sourced environment
  • Thorough experience in quality function, overseeing clinical quality within European guidelines and regulatory standards
  • 5+ years' experience with Pharmaceutical Quality Assurance in the US. Strong HA inspection experience with FDA, MHRA, EMA, and/or PMDA is desirable
  • Has a bias for action and display a sense of urgency
  • Must possess strong skills in leadership, communication, project management, and budget management
  • Demonstrated ability to collaborate, communicate and ensure quality oversight through external parties
  • A working knowledge of databases, including Electronic Document Management Systems (EDMS), is desirable
  • In‐depth knowledge of and ability to interpret and apply GCP, GLP, EU, FDA and ICH regulations, guidelines, and best practices
  • SQA RQAP certification is a plus
  • Full understanding of and practical experience establishing and fostering compliance with ICH E-6 Guideline for Good Clinical Practice and Good Pharmacovigilance
  • Additional certifications as an auditor as well as training regulatory frameworks highly desirable.
  • Expertise in data integrity and CFR Part 11 required
  • Ability to travel 10-30% domestically and internationally

The target salary range for this full-time role is $255,000 - $306,000 + bonus + equity + benefits. Structure Therapeutics determines salary ranges based on level and scope of responsibilities, as well as location. Individual pay is further determined by additional factors, including relevant experience, specific job skills, education and training. More details about the specific salary range for your location will be discussed with you during the hiring process by the StructureTx Talent Acquisition Team.