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Mechanical QA Supervisor (On-site) - Dallas, Texas-logo
Mechanical QA Supervisor (On-site) - Dallas, Texas
Decima InternationalDallas, Texas
Decima International is a professional services company, providing project management and controls services to clients in the United States and the Middle East. Our mission is to become the premier professional services provider across all industry sectors we are engaged in. To accomplish this, Decima International’s founders established a simple yet powerful formula: Approach each client engagement as a partnership , create an environment that attracts the most talented professionals and allows them to flourish, and regulate growth to maintain excellence in our service standards. If you are interested in a long and rewarding career working with high-profile clients on some of the most challenging projects in the world, then Decima is where you belong. At Decima, you will be able to explore incredible growth and professional development opportunities. We are looking for a driven and capable Mechanical QA Supervisor to support us with the development of multiple hyperscale data center projects for one of our top technology clients. This is a client-facing role that requires strong interpersonal, communication and organizational skills, ability to self-direct, client representation, and an emphasis on strong project management fundamentals. Must be able to manage multiple projects concurrently. A strong background in data center development, design, engineering, controls, and operations requirements is a big plus. You will play an integral role in ensuring the development and implementation of the Quality Management System (QMS) in addition to the coordination, performance, and completion of all construction audits and commissioning services of the project. The Mechanical QA Supervisor is accountable for the quality of work performed, compliance with building codes, safety regulations, as well as meeting the project’s contractual requirements set forth by the client. We are looking to bring in dedicated individuals with a passion for innovation and talent for multitasking in a fast-paced environment. We will help you grow, pursue, and fulfill what inspires you so we can make big impacts on the world, together. RESPONSIBILITIES Understand the project scope and requirements. Ensure compliance with quality standards, building codes, safety regulations, and environmental guidelines. Review and verify material submittals for A/E and Client approval. Confirm delivered materials match approved submittals. Manage and review submittals, RFI logs, maintenance logs, and other project documents promptly. Update QC punch lists and coordinate with general contractors (GC) and subcontractors for completion. Conduct internal quality audits and site inspections. Adhere to Quality, Health, Safety, & Environment (HSE) standards. Provide technical support to address operational challenges and client concerns. Plan and inspect Definable Features of Work (DFWs). Develop and implement Audit and Test Plans for quality inspections and testing. Maintain and update Quality manuals, checklists, and forms. Collaborate with third-party QA/QC firms as needed. Participate in Quality Management System (QMS) audits. Build relationships with project partners, consulting engineering firms, public agencies, and clients. Ensure document control compliance and maintain project submittal logs and quality control reports. Verify and document material compliance with approved submittals. Compile and forward project closeout documents, including O&M manuals, as-builts, and warranties. Investigate and address non-conformance issues promptly. Ensure calibration of inspection, measurement, and test equipment. Liaise with the General Contractor, Client, and Project Management team to resolve quality issues. Prepare presentations on progress, findings, and recommendations for management. Review subcontractors’ submittals for compliance. Coordinate and monitor subcontractors, suppliers, direct labor, and materials. Collaborate with public utility suppliers for final service connections. Coordinate activities of inspection agencies. Achieve required MEPS and electromechanical inspections. Assist in preparing periodic QA/inspection progress reports. Review and approve subcontractor work percentages. Oversee commissioning processes. Manage the MEP project closeout to ensure all requirements are met. QUALIFICATIONS Required Qualifications : 15+ years of construction and quality management experience. Bachelor’s degree in mechanical, electrical engineering, or a related field. Experience with managing field engineering, inspection, and NDE related to all QA/QC functions. Proficient with reading, understanding, and interpreting plans, specifications, drawings, contracts, and other documents pertaining to MEP aspects of projects. Ability to develop and manage non-conformance, defects, and reporting programs, including root cause analysis. Ability to ensure correct codes, standards, job specifications, project procedures, and federal and provincial regulations are properly identified, correctly specified in detail, and met or exceeded. Ability to work in high-production environments and respond quickly and effectively under pressure and deadlines while maintaining a professional demeanor. Technical knowledge of materials and construction concepts. Experience working as a Mechanical Quality Supervisor for large commercial, industrial, or mission-critical facilities construction projects. An excellent understanding of construction Quality Management Systems (QMS). Familiarity with punch list procedures and project closeout processes. Strong attention to detail and excellent analytical skills. Strong knowledge of high, medium, and low-voltage systems, HVAC, control systems, commissioning, LEED/Green building projects, and general ground-up construction projects as applicable to MEPS. Preferred Qualifications: Project Management Professional (PMP) certification. Construction Quality Manager Certification (CCQM) US Army Corps of Engineers (USACE) Certified Quality Auditor (CQA) Member of the American Society for Quality Six Sigma Certifications ISO 9001 Green Business Certification (LEED) Strong background in data center development and construction POSITION DETAILS: Primary Location: Dallas, Texas Position: Mechanical QA Supervisor Position Classification: Salary-based full-time regular hours Travel: 10% travel expected Current US work permit required. This position does not offer sponsorship for employment (e.g., H-1B visa sponsorship or transfer not offered) PRODUCTIVITY TOOLS: ​ Microsoft Office Microsoft 365 CxAlloy Job Type: Full-time Schedule: 8-hour shift Work Location: (On-site) Dallas, Texas Decima International is an Equal Opportunity Employer who is committed to the safety and wellbeing of all. All qualified applicants will receive consideration for employment without regard to race, religion, creed, color, national origin, ancestry, sex (including pregnancy, childbirth, breastfeeding, or medical conditions related to pregnancy, childbirth, or breastfeeding), age, medical condition, marital or domestic partner status, sexual orientation, gender, gender identity, gender expression and transgender status, mental disability or physical disability, genetic information, military or veteran status, citizenship, low-income status or any other status or characteristic protected by applicable law. At Decima International, we offer a competitive salary package, including paid time off and performance-based bonuses. We also provide excellent medical, vision and dental insurance for our employees.

Posted 30+ days ago

QA Tech 1st Shift-logo
QA Tech 1st Shift
OSI CareersOakland, Iowa
Perform a variety of line audits and tests during production to ensure that product is being made within specification and that proper production and sanitary procedures are being followed. Job Responsibilities • Audit line internal temperature of cooked products; record. • Audit metal detectors with the use of standards; if detector is faulty, retain product and re-test product made since last successful test. • Perform line audits, recording speed, temperature, weights. • Perform weekly swabs of equipment/gloves and plates of air; package with instructions and send to lab. • Once per shift, gather cooked and raw product samples to send to lab with testing instructions. • Maintain and test shelf life samples; perform organoleptic duties. • Inspect code dates on bags, boxes, and cases based on product specification and production schedule. • Inspect and record cooler and freezer temperatures. • Cook samples 2-3 times per shift from all lines. • Perform hourly piece count of packed box. • Calibrate scales and thermometers daily. • Complete paperwork on employee sanitation compliance. • Follow all safety rules. • Use Personal Protective Equipment (PPE); recognize and practice Good Manufacturing Procedures (GMP). • Keep assigned area clean. • Perform other duties as assigned. Experience & Skills • 3 months of on the job training.

Posted 30+ days ago

Senior/Principal QA Specialist (Contamination Control, Aseptic Operations and Microbiology)-logo
Senior/Principal QA Specialist (Contamination Control, Aseptic Operations and Microbiology)
GenentechHillsboro, Oregon
Hillsboro Technical Operations (HTO) is a drug product & finished goods manufacturing organization responsible for the reliable delivery of Roche’s commercial portfolio & pipeline products. The Operations organization at HTO is divided into 2 manufacturing units, which combine to produce millions of units of life-saving medicine every year to patients around the world. The Opportunity: In this exciting role, you will be part of a highly engaged team that is committed to delivering high quality medicines to patients. You will provide Quality oversight for the contamination control strategy, aseptic operations and microbiology. You will serve as a subject matter expert (SME) and resource for the site on aseptic principles including disinfection, environmental control / monitoring. You will provide guidance to internal and external customers on best practices for executing consistent, reproducible, and compliant contamination control strategies and contamination remediations. You will support validation activities for new facilities and utilities. You will provide technical assessment and approval for changes to the contamination control strategy. You will provide Quality authorization for facility and utility restarts following construction or facility wide maintenance to ensure the environmental control and monitoring.. You will provide input to investigations and deviations involving suspect equipment, utility or facility failures. You will support the development and preparation of regulatory submissions related to the contamination control strategy and environmental monitoring of Genentech manufacturing facilities and processes. You will support training of Manufacturing and Quality on aseptic practices, aseptic processing and aseptic media fills You will collaborate with departments to ensure that environmental control and monitoring activities are executed efficiently for nonroutine activities. Who you are: You hold a B.A. or B.S. degree (preferably in a life science) For the Senior QA Specialist level, you have a minimum of 8 years' experience in the pharmaceutical or biopharmaceutical industry. For the Principal QA Specialist level, you have a minimum of 11 years’ experience in the pharmaceutical or biopharmaceutical industry; or an equivalent combination of education and experience. You have an ability to interpret and relate quality standards for implementation and review. You have the ability to make sound decisions about Quality and technical subjects. You exhibit sound knowledge of cGMPs or equivalent regulations You have flexibility in problem solving and work hours to meet business objectives You have strong technical knowledge of aseptic practices, aseptic processing, cleanroom behaviors and contamination control strategies. You are able to quickly and consistently establish rapport and collaborate effectively with clients, team members and partners.​ The expected salary range for this position based on the primary location for this position of Hillsboro, OR is $94,000- $174,000 (Senior level) or $114,000- $211,900 (Principal level). Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Link to Benefits Relocation benefits are provided #gnehtoquality Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants .

Posted 1 week ago

Sr. QA Systems Analyst-logo
Sr. QA Systems Analyst
loanDepotPlano, Texas
Description Position at loanDepot Position Summary: The Senior QA Systems Analyst is responsible for providing software quality assurance support for all Company products. Utilizes familiarity with the complete SDLC and knowledge of test processes and planning. Creates supporting documentation, including test plans, use cases, bug and status reports as well as interfaces with customers on major projects. Requires having a proven track record of delivering quality projects within very tight deadlines. Responsibilities : Leads, coaches, and mentors’ analysts in the implementation/communication of associated testing activities throughout a given project; manages career development of Quality Assurance (QA) Analysts. Works with project leaders and business owner(s) to identify a structured test strategy and/or test methodology for a given project/initiative. Estimates the amount of testing effort necessary to complete a given project/initiative Establish test plans for a given project to include the testing software needed, the scope, approach, resources and schedule of intended test activities. Establishes and clearly communicates risk assessments associated with testing and determines the level of detail necessary to adequately validate the impact a given risk may have on a project or task. Directs problem resolution, decision making, communications, and other associated activities during all phases of large, complex projects. Performs quality assurance/software testing processes, methodologies, and procedures as part of contributing to software quality. Completes test planning, functional testing, regression testing, and integration testing along; troubleshoots concerns addressed and debugs as necessary. Documents and tracks defects found till closure. Performs SQL queries for data comparison and validation. Presents clear and comprehensive status reports to stakeholders for one or more projects according to departmental standards. Acts as a subject matter expert on a variety of applications relevant to business environment. Continuously looks for and suggests process improvements to ensure quality product testing and production. Works in a team environment with flexibility in taking on multiple maintenance tasks/projects and software upgrades simultaneously while collaborating with team on and off-site Participates in after-hours deployment efforts and post-deployment verification. Performs other duties and projects as assigned. Requirements : Bachelor’s Degree required with a minimum of six (6) + years of work experience in software quality assurance. Experience leading small quality teams on large or specialized projects preferred. Mortgage experience desired. Empower LOS experience a plus. Minimum of two (2) + years SQL experience is desired. Experience working in an agile/scrum model is a plus. Demonstrates knowledge of the QA testing methods: unit, integration, regression, user acceptance testing. Demonstrates ability to perform root cause analysis. Strong analytical skills with keen attention to detail. Demonstrates knowledge of Azure, JIRA or other Test Management tools. Intermediate skills in computer terminal and personal computer operation; Microsoft Office applications including but not limited to: Word, Excel, PowerPoint, and Outlook. Intermediate math skills; calculating interest and percentages; balance accounts; adding, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals; locate routine mathematical errors; compute rate, ratio and percent, including the drafting and interpretation of bar graphs. Effective organizational and time management skills. Exceptional verbal, written and interpersonal communication skills. Ability to make decisions that have moderate impact on the immediate work unit and cross functional departments. Ability to organize and prioritize work schedules on a short-term and long-term basis. Ability to make informal and formal presentations, inside and outside the organization; speaking before assigned team or other groups as needed. Ability to deal with complex difficult problems involving multiple facets and variables in nonstandardized situations. Ability to work with no supervision while performing duties. Ability to work under pressure and to meet tight deadlines in fast paced, dynamic environments. Excellent interpersonal and organizational skills, ability to handle diverse situations, multiple projects, and rapidly changing priorities Excellent written, verbal, and presentation communication skills, especially in representing your technical expertise to a diverse audience. Why work for #teamloanDepot: Competitive compensation package based on experience, skillset and overall fit for #TeamloanDepot. Inclusive, diverse, and collaborative culture where people from all backgrounds can thrive Work with other passionate, purposeful, and customer-centric people Extensive internal growth and professional development opportunities including tuition reimbursement Comprehensive benefits package including Medical/Dental/Vision Wellness program to support both mental and physical health Generous paid time off for both exempt and non-exempt positions About loanDepot: loanDepot (NYSE: LDI) is a digital commerce company committed to serving its customers throughout the home ownership journey. Since its launch in 2010, loanDepot has revolutionized the mortgage industry with a digital-first approach that makes it easier, faster, and less stressful to purchase or refinance a home. Today, as the nation's second largest non-bank retail mortgage lender, loanDepot enables customers to achieve the American dream of homeownership through a broad suite of lending and real estate services that simplify one of life's most complex transactions. With headquarters in Southern California and offices nationwide, loanDepot is committed to serving the communities in which its team lives and works through a variety of local, regional, and national philanthropic efforts. Base pay is one part of our total compensation package and is determined within a range. This provides the opportunity to progress as you grow and develop within a role. The base pay for this role is between $92,000 and $126,500. Your base pay will depend on multiple individualized factors, including your job-related knowledge/skills, qualifications, experience, and market location. We are an equal opportunity employer and value diversity in our company. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Posted 5 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

Sr. IVD QA Manager-logo
Sr. IVD QA Manager
VeracyteSouth San Francisco, CA
At Veracyte, we offer exciting career opportunities for those interested in joining a pioneering team that is committed to transforming cancer care for patients across the globe. Working at Veracyte - whether it be in one of our labs, corporate offices, the field - enables our employees to not only make a meaningful impact on the lives of patients, but to also learn and grow within a results-driven environment that values innovation, collaboration, and compassion. The Position: We are looking for an energetic and self-motivated Quality professional who will be excited to build an IVD QA team and lead the implementation of a new IVDR-compliant Quality Management System. In this role, the Senior IVD QA Manager will be responsible for building an IVD Quality team and managing this team in the development and implementation of a Quality Management System that includes quality processes and procedures, automated systems, and ensuring compliance with all applicable internal, domestic, and international quality regulations, including ISO 13485, IVDR, and others global regulations and standards. This is a hybrid role (in office at least 3 days a week) and is based out of our headquarters in South San Francisco (SSF), California, United States. Develop, implement, and maintain a Quality Management System (QMS) in accordance with ISO 13485 and applicable standards and regulations for in vitro diagnostic (IVD) products. Develop and monitor QMS metrics and quality records to ensure timely review, closure, and continuous improvement of system effectiveness. Drive continuous improvement across the quality system to support scalability, compliance, and operational efficiency. Oversee implementation and administration of an electronic QMS (eQMS), including system configuration, user training, and ongoing maintenance. Manage core quality system processes, including document control, training, change control, nonconformance handling, CAPA, and internal audits. Plan, conduct, and document internal audits; track audit findings and ensure effective implementation of corrective and preventive actions. Support supplier qualification and oversight, including supplier audits, performance monitoring, quality issue resolution, and Quality Agreement management. Collaborate with external partners such as contract manufacturers and laboratories to ensure quality expectations and regulatory requirements are met. Lead Management Review meetings. Lead and deliver quality training to staff to ensure competency and adherence to QMS procedures. Maintain a proactive state of audit/inspection readiness and lead external audits by regulatory bodies, partners, or customers. Who You Are: BS/BA degree in a science-related or technical field or equivalent combination of work experience. Minimum 10 years progressively responsible work experience in medical device or regulated industries. Minimum 6 years of direct supervisory experience. Working knowledge of IVD-specific quality system requirements, including application of ISO 13485 in the design & development and validation of IVD products; knowledge of FDA Quality System Regulations a nice to have. Provide direction and leadership for product quality and compliance. Ability to collaborate across functions and technical teams, including IVD development and contract manufacturers, is a must. Experience implementing and/or managing Document Control using an electronic Quality Management System (eQMS). In depth knowledge of core quality system processes including CAPA, nonconformance management, audits, training, document control, and change control. Experience conducting internal audits and leading external ISO audits or third-party assessments. Strong organizational skills to manage multiple simultaneous projects in a fast-paced environment. Attention to detail in understanding and documenting complex quality issues. Strong writing skills to summarize complex issues clearly and accurately. Strong communication, problem-solving, and motivational skills. Highly organized, self-motivated, and comfortable working in a fast-paced IVD environment. Familiarity with CLIA requirements and operational considerations for laboratory-developed tests (LDTs) is a nice to have. Expected domestic travel up to 20%. #LI-Hybrid The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Base pay is one part of the Total Package that is provided to compensate and recognize employees for their work, and this role may be eligible for additional discretionary bonuses/incentives, and restricted stock units. Veracyte is a multi-state employer, and this salary range may not reflect positions that work in other states. Pay range $170,000—$190,000 USD What We Can Offer You Veracyte is a growing company that offers significant career opportunities if you are curious, driven, patient-oriented and aspire to help us build a great company. We offer competitive compensation and benefits, and are committed to fostering an inclusive workforce, where diverse backgrounds are represented, engaged, and empowered to drive innovative ideas and decisions. We are thrilled to be recognized as a 2024 Certified Great Place to Work in both the US and Israel - a testament to our dynamic, inclusive, and inspiring workplace where passion meets purpose. About Veracyte Veracyte (Nasdaq: VCYT) is a global genomic diagnostics company that improves patient care by providing answers to clinical questions, informing diagnosis and treatment decisions throughout the patient journey in cancer and other diseases. The company's growing menu of genomic tests leverage advances in genomic science and technology, enabling patients to avoid risky, costly diagnostic procedures and quicken time to appropriate treatment. The company's tests in lung cancer, prostate cancer, breast cancer, thyroid cancer, bladder cancer and idiopathic pulmonary fibrosis are available to patients and its lymphoma subtyping and renal cancer tests are in development. With Veracyte's exclusive global license to a best-in-class diagnostics instrument platform, the company is positioned to deliver its tests to patients worldwide. Veracyte is based in South San Francisco, California. For more information, please visit www.veracyte.com and follow the company on X (Formerly Twitter). Veracyte, Inc. is an Equal Opportunity Employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status or disability status. Veracyte participates in E-Verify in the United States. View our CCPA Disclosure Notice. If you receive any suspicious alerts or communications through LinkedIn or other online job sites for any position at Veracyte, please exercise caution and promptly report any concerns to careers@veracyte.com

Posted 30+ days ago

Engineer I, QA-logo
Engineer I, QA
Thermo Fisher ScientificMarietta, Ohio
Work Schedule First Shift (Days) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description At Thermo Fisher Scientific team, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us. Location/Division Specific Information Located in Marietta, OH, at 401 Millcreek Road. Join the Laboratory Products Division, aiding life sciences research and global quality of life. Discover Impactful Work: Join Thermo Fisher Scientific’s Quality Assurance team and make a difference in a global, dynamic organization. Your role will be important in ensuring flawless quality and compliance, supporting our mission to drive growth and innovation. A day in the Life: Knowledge of Regulatory and Quality system requirements (ISO 13485:2016, 21 CFR Part 820) Partnership with other site areas to drive a culture of continuous education of the Quality Management System Participate in Customer / Internal audits Apply problem-solving skills related to quality issues to ensure timely resolution with minimal impact Embrace site PPI initiatives and adopt this methodology in day-to-day tasks Participate in plant-wide efforts in corrective and preventive actions, focusing on customer returns and root cause solutions. Provide Quality support for product-related investigations, deviations, change controls, validation protocols, validation reports, and SOPs Keys to Success: Ability to communicate effectively with multiple levels of leadership. Proficiency in technical writing and experience with various software applications, including Excel Possess organizational to manage and prioritize multiple tasks Ability to achieve deadlines in a fast-paced environment Capability to work independently and collaboratively Education Minimum Bachelor's degree; 0-3 years' equivalent experience preferred; applicable experience will be considered Experience Three years’ experience in Quality systems based in ISO 13485:2016 and 21 CFR 820 preferred Three years’ experience in a manufacturing environment required Knowledge and experience working in the manufacturing of medical devices preferred Knowledge, Skills, Abilities Strong analytical and problem-solving skills Effective interpersonal skills across all organizational levels Strong technical writing abilities and familiarity with software applications like MS Office or similar, SAP, Salesforce. Capable to prioritize in a fast-paced manufacturing organization. Model the principles of the quality culture. Experienced in investigations and root cause analysis, non-conforming product and CAPAs. Physical Requirements / Work Environment This role requires the ability to work standing, walking, and occasionally lifting up to 25 pounds. Adherence to safety protocols is required. Benefits We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation! Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. Apply today! http://jobs.thermofisher.com Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. Accessibility/Disability Access Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process. *This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

Posted 30+ days ago

QA Specialist I/II-logo
QA Specialist I/II
KBI BiopharmaDurham, North Carolina
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 Analyst-logo
QA Analyst
Daybreak GamesSan Diego, California
Position Title: QA Analyst Studio/Department: Quality Assurance Employee Type: Full Time Location : San Diego, CA/Remote (Daybreak Approved Remote Locations (CA, WA, TX, NY)) Salary Range: $14.00 - $17.00 per hour, pay may vary on location. ABOUT OUR STUDIO Our headquarters is where the gaming culture and Southern California lifestyle meet, creating a vibrant work environment that epitomizes our belief that every day should be well played. Daybreak San Diego is the home of Darkpaw Games, creators of the legendary EverQuest and EverQuest II games. This is also the home of Rogue Planet Games, developer of the award-winning MMOFPS PlanetSide 2. The perks of working at Daybreak San Diego extend well beyond the beautiful weather in this prime location. Access to the local gym, as well as on-site fitness classes, game nights, and a strong appreciation for the local craft brew scene (we even turned one of our original game servers into an on-site kegerator) are just some of the ways that make working at Daybreak (San Diego) exciting! Working here is about being part of a community. Find out more about our studio at www.daybreakgames.com . THE OPPORTUNITY The Quality Assurance Analyst is responsible for for testing multiple aspects of our video game titles on various platforms ranging from PC, PlayStation 4 and the Xbox One in the QA Department at San Diego, CA; this position will be responsible for: Develop test suites by evaluating feature specifications Attend spec reviews, daily scrum stand-ups, planning meetings, etc. Provide test guidance to remote testers Execute test suites (authored by you or others) Report, review and document bug reports Verify bug fixes Critically evaluate test scope and coverage, plan and execute ad hoc testing, boundary/edge case testing, exploratory testing as needed Document QA processes on Confluence wiki Surface blocking issues and risks; Make recommendations for resolving blocking issues or mitigating risks Proactively drive testing to completion Assure patches/updates, new builds and shipped products are functional and meet quality standards Follow Daybreak Games Tester procedures outlined by the QA Leads and Management Be consistently proactive with QA process improvements Continually develop and acquire game knowledge to become proficient with Daybreak Games' portfolio of games Other Criteria Years of Experience, Education, and/or Certification… Knowledge of Microsoft Windows and Microsoft Office products (Outlook, Word, and Excel) Experience with consoles (e.g., PlayStation, Xbox platforms) Education High School Graduate or equivalent Ability to follow verbal and written instructions Strong analytical and organizational skills Available to work any shift Working background in Quality Assurance or 1+ years in the gaming industry Working knowledge of the software development process Knowledge of Daybreak Game Company games preferred Knowledge of Video Games on PC and Consoles preferred We invite you to get in the game with us and help us make exciting experiences! ABOUT OUR COMPANY Daybreak Game Company LLC is a recognized worldwide leader in massively multiplayer online games. Best known for blockbuster hits and franchises such as DC Universe™ Online, PlanetSide®, EverQuest®, and Dungeons and Dragons Online®, Daybreak creates, develops, and provides compelling online entertainment for millions of gamers worldwide. We are the game publisher for Darkpaw Studios, Rogue Planet Gaming Studio, Dimensional Ink Games, and Standing Stone Games. To top it off, we are making games in three of the coolest cities in the United States: San Diego, Austin, and Boston. We make games that bring people together and build lasting communities and are totally devoted to delivering the ultimate gaming experience! Find out more about our company at www.daybreakgames.com . Be Aware of Fraudulent Recruiting Activities Daybreak Game Company will never ask applicants for social security numbers, date of birth, bank account information or other sensitive information in job applications. Additionally, our recruiters do not communicate with applicants through free e-mail accounts (Gmail, Yahoo, Hotmail) or through online messaging apps (WhatsApp, Hangouts). We will never ask applicants to provide payment during the hiring process or extend an offer without conducting a phone, live video or in-person interview. Please contact Daybreak Game Company’s People & Culture team at people@daybreakgames.com if you encounter a recruiter or see a job opportunity that seems suspicious. * Daybreak Game Company, LLC. is an Equal Opportunity Employer, committed to Diversity in the workplace. *

Posted 1 week ago

QA Lead-logo
QA Lead
LaudioBoston, Massachusetts
About Us Laudio empowers healthcare leaders to drive large-scale change through everyday human actions. Our platform streamlines workflows for frontline leaders, strengthens interpersonal connections, and aligns C-suite objectives with frontline efforts, enhancing leader efficiency, employee engagement, and patient experience. Laudio makes it possible for patients, frontline workers, and health system leaders to thrive together. Discover how at www.laudio.com . Job Title: QA Lead – Hands-On | Client-Facing | Global Collaboration Location: Remote (with early EST hours and occasional travel to Nepal) Job Requirements : Must be US-based, no visa sponsorship available for this role About Laudio: At Laudio, we build software that empowers healthcare leaders to better support their teams—improving outcomes for staff and patients alike. Our culture is grounded in purpose, collaboration, and continuous improvement. As we scale, we’re looking for a passionate QA Lead to elevate our product quality and drive smarter, faster resolution of client-reported issues. Role Overview: We're seeking a hands-on QA Lead who thrives on ensuring product quality and solving complex client-reported issues. This role is ideal for someone who’s not only technically strong in QA best practices but also excels at triaging support issues and bridging communication across cross-functional teams—onshore and offshore. You'll play a critical role in owning and evolving our quality assurance process, with a strong emphasis on support triage , root cause analysis, and collaboration with our Nepal-based team. What You'll Do: Lead with impact – Guide and mentor a global QA team, driving consistent quality practices and continuous improvement. Champion the customer experience – Triage, analyze, and prioritize real-world issues reported by clients, turning feedback into actionable insights. Build quality in – Design and execute test strategies, test plans, and edge-case scenarios based on product specs and user workflows. Own the release gate – Validate patches and new features through rigorous regression, functional, and exploratory testing. Drive visibility – Track and report on quality metrics, issue trends, and SLA adherence to ensure transparency and accountability. Collaborate deeply – Act as a key liaison between QA, Product, and Engineering teams, especially across time zones, to ensure timely resolution of client-impacting issues. Invest in the team – Train and uplift junior QA members, fostering a culture of ownership, learning, and high standards. What We're Looking For: 6+ years in software testing roles, with 2+ years in QA leadership or issue triage-focused roles Deep knowledge of QA methodologies, defect tracking systems (Jira), and test management tool Strong analytical, troubleshooting, and root-cause analysis skills Excellent communicator – able to translate technical details into clear, actionable insights for stakeholders Experience in fast-paced product environments, ideally with SaaS or customer-facing platforms Familiarity with support workflows and SLA-driven environments Experience with test automation tools is a big plus Background in software development is a strong plus Work Requirements: Start time: Must be able to collaborate with our Nepal team starting at 7:00 AM EST Travel: Occasional travel to Nepal based on project needs Work Status : Must be US-based with no visa sponsorship requirements Key Skills: QA methodologies & strategy Client support triage & prioritization Regression & exploratory testing Bug tracking & lifecycle management Test planning & execution Automation familiarity (e.g., Selenium, Cypress, etc.) Root cause analysis Cross-functional communication Team leadership & mentoring Why Join Laudio? Make a real-world impact by improving quality in a platform that supports healthcare workers Work in a fast-moving, purpose-driven environment Collaborate globally with passionate and talented teams Take ownership and help shape QA strategy across the company Laudio Data Privacy Policy here . A warning about recruiting scams : you should only respond to interview requests from people with a Laudio email address or authorized 3rd party recruiting agencies (check for the company's website before responding to ensure the person contacting you is legitimate). A Laudio employee will not solicit candidates through a non-Laudio email address like Yahoo, Hotmail or Gmail. Also, all our interviews are conducted via Zoom or phone call (never via Skype or WhatsApp). Laudio is an equal opportunity employer and an E-Verify employer.

Posted 1 day ago

QA Tech 2 - 1st shift-logo
QA Tech 2 - 1st shift
BA Candidate GatewayYuma, Arizona
Position : QA Tech 2 (Post Harvest) Department : Agronomy Reports To : Sr. Field Quality Manager Salary Type : Non_Exempt Location : (Seasonal position ) Yuma, AZ. November 1st through March 31st Holtville, CA. November 15 through March 31 Salinas, CA April 1st through October 31st Groupe Bonduelle is a company that is making a positive impact Groupe Bonduelle is the world leader in ready-to-use plant-rich food. By joining our company you will have an opportunity to make a positive and sustainable impact on yourself, others and the planet. You will play an active part in our mission to inspire the transition toward a plant-rich diet to contribute to people's well-being and planet health. Groupe Bonduelle Fresh Americas is the U.S. business unit of France based Groupe Bonduelle (BON.PA). We are the first business unit of Groupe Bonduelle to become a Certified B Corporation. We operate three processing facilities throughout the U.S. and employ nearly 3,000 Associates who focus on producing and bringing to market fresh vegetable products, prepared salads and plant-rich meal solutions. Groupe Bonduelle is a 170 year old French family-owned company that has been at the forefront of plant based food innovations since 1853. Our ready-to-use plant-rich food products are grown on 168,000 acres by our grower partners and marketed in nearly 100 countries. The company currently employees more than 11,000 Associates globally. Join us at Bonduelle Fresh Americas for an opportunity to advance your career in a culture that places people first and makes contributing to a better future through plant-based food our top priority. Position Summary : This role is a key QA role within our Agriculture Operations and supports QA team leads as they ensure compliance with food safety and quality requirements by fully embracing the Company’s RCE philosophy. This position is exposed to multiple refrigerated areas. And support to inspect all inbound raw produce loads at cooling facilities. The candidate in this position must be self-motivated, problem solver with excellent communication skills and strong intrapersonal skills. Must be able to work unsupervised. What you will Do : Raw product inspection Sampling raw product for inspection Conduct checks Oxygen levels in sealed bins of C&C Iceberg lettuce and Trim Romaine Conduct temperature checks of raw product as necessary Conduct color ration evaluation of Raw romaine Enter results of evaluation into “Paperless” data system Completion of Supplier Notification forms Complete daily inspection reports into Ready BFA data Management System (Paperless) Communicate with Ready Pac field personnel on raw quality issues Communicate with Ready Pac processing facilities on raw quality issues Communicate with raw suppliers on quality issues related to inspection at the cooler Communicate with cooler personnel on raw inspection or cooling process issues. Issue daily inspection report to all RP processing facilities. Follow BFA food safety, and safety policies as applicable to the cooler operation. Conduct other duties related to raw quality, as assigned by the department manager. Minimum Qualifications : Post Harvest inspection experience is desired. Good computer skills (familiar with Microsoft Excel, Microsoft Access, Microsoft Word, Paperless). Good written and oral skills Familiar with Fresh Cut processing Familiar with USDA inspection standards Familiar with raw inspection procedures Bilingual (English/Spanish) is desired. Must be able to work in cold environment Must be able to lift 50 lbs. Must be able to work in a high pace environment Ability to work independently, unsupervised and in a team environment. Must be able to monitor product/process to identify and address any non-compliance Physical Work Environment / Demands: While performing the duties of this job, the associate will be required to perform repetitive movements (i.e., scooping condiments into salad bowls). The associate regularly works near moving mechanical parts and is regularly exposed to extreme cold. The noise level in the work environment is usually loud. Ability to sit or stand for extended periods. Ability to move about within a fast-paced environment in/outside facility, and traverse between the maintenance shop & production floor. Ability to position self to stoop, kneel, crouch, or crawl Ability to frequently move, push, or carry items up to 50lbs Exposed to a cold & wet environment of 34 degrees. Ability to work in outdoor weather conditions Must be able to exchange accurate information through frequent communications within all levels of the organization Must be able to detect, identify, inspect, observe, and assess surroundings

Posted 30+ days ago

QA Operations Specialist-logo
QA Operations Specialist
Tolmar CareersFort Collins, Colorado
Core Hours: Monday - Friday, 8am-5pm Purpose and Scope The Quality Operations Specialist is responsible for providing technical quality oversight for Tolmar manufacturing operations in accordance with company policies, standards, procedures and current Good Manufacturing Practices (cGMP). Functional responsibilities will include supporting the design and implementation of quality systems for new manufacturing processes and continuous improvement of the quality systems within current manufacturing processes, especially within sterile processing. They will serve as a quality point of contact for the operations teams and will use risk-based decision making to address any issues on the manufacturing floor. The position will also create, revise and review/approve quality records that support the manufacturing operations, such as, standard operating procedures, work instructions, change controls and investigations ensuring accuracy and appropriateness. Essential Duties & Responsibilities Demonstrate a high level of discretion in the timely identification and resolution of events potentially impacting the Quality of products and processes. Work effectively with Operations, Maintenance, and Engineering to make immediate, risk- based decisions; escalate issues to QA management as necessary. Follow all regulatory guidelines, cGMP guidelines, and aseptic techniques as required by the job function. Responsible for providing Quality oversight to ensure that products are manufactured and stored in accordance with cGMP, other applicable regulations and internal company policies and procedures. Support department supervision in oversight and prioritization of day-to-day responsibilities. Perform investigations for the Quality Operations team. Provide quality support and approval for deviations associated with operations and environmental monitoring excursions, determining immediate actions, assisting with investigation and assessing impact. Create, revise and review documents: SOPs, work instructions, qualification documentation and other Quality documentation directly related to operations and other cGMP activities. Independently lead projects to address quality gaps or drive continuous improvement for Operations or Quality Systems. Coordinate/Manage Tolmar’s program for Sterile Process Oversight. Develop standard work and ensure completion of routine activities within established timelines. Support internal and external audits of Tolmar Quality Systems/Operations. Represent department in internal and external cross-functional teams. Perform observation of activities in a clean room environment requiring clean room gowning, including but not limited to: Company-provided Scrubs Shoe Covers and Sterile Boot Covers Hairnets (and beard covers as applicable) Tyvek/Sterile Coveralls Gloves Full-face masks/hoods Goggles Chemical Protection PPE Perform other duties as assigned. Knowledge, Skills & Abilities Knowledge in cGMP, 21 CFR 210, 211, 820 and ISO 13485. Independent, organized and able to lead others to meet deadlines. Ability to work in an independent and self-directed manner. Ability to clearly communicate (oral & written) and work well with employees at all levels. Able to prepare written communications and communicate problems to management with clarity and accuracy. Ability to write procedures and reports clearly and accurately. Ability to recognize and group technical/scientific attributes and drive science-based decisions in most technical areas and to a deeper level in the specific job function. Ability to critically review investigations and reports, interpret results, and generate technical conclusions consistent with quality risk management principles. Comfortable in a fast-paced environment and able to adjust workload based upon changing priorities. Computer literacy in Microsoft Word, Access, Excel and other MS Office programs. Recognized subject matter expert on quality assurance topics within an operations environment. Core Values The Quality Operations Specialist is expected to operate within the framework of Tolmar’s Core Values: Center on People: We commit to support the well-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together.​ Are Proactive & Agile: We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.​ Act Ethically: We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace. ​ Constantly Improve: We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality.​ Are Accountable: We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.​ Education & Experience Bachelor’s degree required, in scientific discipline preferred: engineering, microbiology, chemistry or biochemistry. Five or more years of experience in the pharmaceutical industry working in quality or manufacturing. Experience in Aseptic manufacturing preferred. Working Conditions Core hours are from 8 AM – 5 PM Monday through Friday, with availability to work extended hours on evenings and/or weekends as necessary. This position will work in an office area, as well as in manufacturing areas as needed. Compensation and Benefits Annual pay range $70,000 - $80,000 depending on experience Benefits information: https://www.tolmar.com/careers/employee-benefits Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience. Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.

Posted 30+ days ago

Lead Construction QA/QC – Disaster Recovery-logo
Lead Construction QA/QC – Disaster Recovery
ICForporatedTallahassee, Florida
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 to provide needed reasonable accommodations. Read more about workplace discrimination righ t s 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 1 week ago

Financial Crimes QA Analyst-logo
Financial Crimes QA Analyst
FargoFargo, North Dakota
Job Summary The Financial Crimes Quality Assurance Analyst is responsible for performing and assisting in the creation of quality assurance of BSA/AML/Fraud processes. This role will assist in developing and executing a risk-based Quality Assurance (QA) program focused on the review of the design, effectiveness, and overall quality of AML (Anti Money Laundering) alert reviews, case investigations, Currency Transaction Reports (CTRs), Suspicious Activity Reports (SAR), Customer Due Diligence(CDD) reviews, and Enhanced Due Diligence (EDD) reviews of higher risk members as it relates to applicable regulations and adherence to relevant policies, procedures, and processes. This role is responsible for preparing reports on findings, recommending enhancements, and reporting the status of corrective actions. Responsibilities Assist in the development of the Financial Crime Quality Assurance program and associated testing and reporting activities. Perform quality assurance reviews on a scheduled cadence and additional ad hoc testing as needed. Ensure key and emerging Financial Crime risks and controls are accurately implemented across the institution. Assist the Financial Crime team in identifying compliance gaps and improvement opportunities. Contributes input to creating technology-based tools and metrics to create effective and efficient reporting of Fintech risks with the goal of minimizing risk exposure. Works effectively with stakeholders and risk teams. Qualifications 3+ years in financial crimes/anti-money laundering group. 3+ years of experience in the execution of quality assurance testing processes associated with financial industry legal, regulatory, risk, and compliance obligations. Performing and assisting in the creation of quality assurance processes and testing across the Financial Crimes compliance team Extensive understanding of regulatory expectations within the financial industry and ability to demonstrate compliance and risk-based decisions. Ability to maintain control, direction, and motivation in an ever-changing environment. Strong analytical and reporting skills including experience with a wide variety of reporting tools (e.g., Excel, Tableau, BI Reporting). Effective communication skills – both verbal and written. Demonstrated ability to work independently and collaboratively to drive efficient resolution of decisions and tasks, escalate items requiring attention, and proactive approach at problem solving and continuous improvement. CAMS (Certified Anti-Money Laundering Specialist) certification or pursing certification preferred. Bachelors degree, or equivalent experience preferred. Cultural Alignment Choice is #PeopleFirst, banking second. People don’t need just another bank. People need to be supported by a team of trusted partners who will get to know them and their business, understand their challenges, discover their dreams, and recognize the success in bringing people and banking together in our communities. In contributing to our culture, Choice team members are guided by our core values. Embrace change and encourage innovation. Know when to ask for help and know when to offer help. Better the places we live. Work hard. Do the right thing. Have a little fun. Our vision of Diversity at Choice is supported by our #PeopleFirst mission and our core values. Being #PeopleFirst means that Choice is committed to focusing attention and resources towards creating an environment where everyone feels respected and valued and can do their best work. Doing the right thing means encouraging employees to share their experiences and ideas, and to bring their whole authentic selves to work. Together, we can build an inclusive culture that seeks out, supports, and celebrates diverse voices. We can use our diversity to fuel creativity and innovation and bring us closer to our customers and the communities we serve. Be welcome at Choice. We can see you here.

Posted 2 weeks ago

Sr QA Specialist-logo
Sr QA Specialist
KBI BiopharmaDurham, North Carolina
This position is responsible for the compliance review of Biopharmaceutical Development GMP data. This includes the review and approval of release, in­ process, and stability test data. This position is also responsible for the review and approval of method qualifications and validations. Another responsibility is the review and approval of laboratory investigations and deviations associated with the biopharmaceutical development department. Job Responsibilities: Perform compliance review on the following records - release, in process, and stability data Responsible for the review and approval of method qualifications and validations Responsible for the review and approval of deviations and laboratory investigations Minimum Requirements: BS and 14+ years experience or MS and 11+ years experience in a CGMP regulated environment within biopharmaceutical or equivalent Experience in QA review of analytical data (release, in process, and stability), Experience in reviewing method qualifications/validations and the review and approval of laboratory investigations and deviations. Knowledge of USP, EU and JP cGMP guidelines Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures or governmental regulations Ability to write reports, business correspondence, and procedure manuals ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Basic math skills are required Ability to apply concepts of basic algebra and statistics Ability to sit for long periods of time and to be able to lift 20 pounds ability to use word processing, databases, spreadsheets, PowerPoint, internet, email, calendar, computer, telephone 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 30+ days ago

QA Coordinator - Clinical Research-logo
QA Coordinator - Clinical Research
CenExelRiverside, California
About Us: Each of CenExel’s research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success. Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k. Hourly Range: $27.00 - $30.00/hr - Depending on Experience Schedule: Monday - Friday 08:00am - 4:30pm Job Summary: Ensure that highest standards of data quality and study participant safety are maintained, as well as adherence to study protocols, CenExel SOPs, Site Working Practices (WPs), ICH GCP, Code of Federal Regulations, and IRB Guidelines. Essential Responsibilities and Duties: Assists the QA Manager in the development, implementation and follow-up of quality assurance programs including necessary or appropriate policies and guidelines. Reviews follow-up monitoring visit reports, protocol deviation logs, and quality findings trackers for trend analysis. Performs ongoing review of a percentage sampling of study inclusion/exclusion, study procedure records, and laboratory reports to ensure that they are conducted according to the protocol, applicable SOPs, ICH/GCP guidelines and federal regulations. Performs quality review of initially created source documentation, including amendments, to ensure all protocol required procedures are present. Prepares for internal and external audits and FDA inspections. Attends staff meetings. Attends site initiation visits as needed. Supports and ensures strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site working Practices, protocol, and company guidelines and policies. Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive. Education/Experience/Skills: Must be able to effectively communicate verbally and in writing. High school graduate or equivalent, Bachelors degree or equivalent preferred. Minimum 1-2 years relevant experience in the clinical research industry (Required) Knowledge/Skills/Abilities: Must be self-directed and able to work with minimal supervision; Must have in depth knowledge of FDA regulations. GCP, and ICH guidelines; Able to take a flexible approach to shifting priorities; Able to manage multiple projects and responsibilities; Motivated to work consistently in a fast paced and rapidly changing environment; Must be detail oriented and have exceptional computer, organizational, and communication skills – both written and oral. Must reflect the professional image of the company, upholding the company vision in actions, demeanor, and appearance. Must be able to clearly communicate through written and verbal means with sponsors and staff. Working Conditions Indoor, Office environment. Essential physical requirements include sitting, typing, standing, walking. Lightly active position, occasional lifting of up to 20 pounds. Reporting to work, as scheduled, is essential. On-site work arrangement. CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.

Posted 30+ days ago

QA Lead-logo
QA Lead
BranchSeattle, Washington
We are an early-stage game development company behind the free-to-play massively-multiplayer online sandbox survival game Castaways. Our sole purpose is to explore and develop groundbreaking ideas that seamlessly merge the worlds of social apps and gaming, redefining the very fabric of interactive entertainment. We invest in people who have surmounted many obstacles yet remain steadfast with an unwavering determination to cultivate the remarkable and enduring. You would be a great fit at Branch if you are a detail-oriented subject matter expert in your domain and enjoy working with small teams to build and ship quality games on a rapid timeline. As a QA Lead, you will play a pivotal role in ensuring the quality and integrity of our game Castaways. You will be the first QA hire and work closely with developers, artists, and producers to identify and address issues, implement testing strategies, and uphold the high standards of quality that our studio strives to be known for. Responsibilities: Collaborate with the development and production teams to align QA efforts with project goals and timelines. Develop comprehensive test plans, test cases, and test strategies for bi-weekly releases, considering various platforms and devices. Implement and maintain efficient testing processes and workflows to prevent bugs and regressions from reaching production. Execute manual and automated tests, including functional, regression, and performance testing, to identify and report defects. Conduct compatibility testing across different platforms and devices. Ensure adherence to established quality standards and guidelines. Track and manage defects using bug tracking tools, prioritize issues, and ensure timely resolution. Provide clear and detailed bug reports, including steps to reproduce and relevant information for developers. Collaborate closely with cross-functional teams to communicate QA findings, facilitate bug triage meetings, and drive resolutions. Provide feedback to the development team to improve the overall quality of our games. Identify opportunities to enhance QA processes and tools, and implement improvements. Qualifications: Bachelor's degree in a relevant field or equivalent work experience. Proven experience in game QA testing, with at least 2 years of experience in a QA leadership role. Strong understanding of game development processes and methodologies. Proficiency in using QA tools and bug tracking software. Excellent communication, leadership, and problem-solving skills. Experience with manual, automated, functional, regression, and performance testing. Bonus experience: Experience with outsourcing QA teams for extra support Experience being the only QA person on a small team $130,000 - $180,000 a year Salary Range: $130,000 - $180,000 We invite you to join our passionate team, where your expertise will make a lasting impact on our game's success. Be part of our exciting journey as we create captivating experiences for millions of players worldwide. Together, let's shape the future of gaming and build something truly extraordinary. Benefits: 1. Work remotely or on site. 2. Platinum tier health, dental, and vision insurance 100% paid for by us for you and your dependents. 3. Unlimited paid time off and sick leave policies. 4. 401(k) with employer matching. Branch is proud to be an equal-opportunity employer. We do not discriminate in hiring or any employment decision based on race, color, religion, national origin, age, sex (including pregnancy, childbirth, or related medical conditions), marital status, ancestry, physical or mental disability, genetic information, veteran status, gender identity or expression, sexual orientation, or other applicable legally protected characteristics. Branch considers qualified applicants with criminal histories consistent with applicable federal, state, and local law. Branch is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation made due to a disability, please let your recruiter know.

Posted 30+ days ago

QA Inspector-logo
QA Inspector
Pretium PackagingBethlehem, Pennsylvania
Job Summary Responsible for the in-process inspection and testing of bottles. Must be able to audit and assist Inspector Packers with the visual inspection of bottles, the overall cleanliness and organization of the plant and report any quality problems and non-conformances to the Production and/or Quality Supervisor immediately. Must follow Alpha’s standards for Safety, Housekeeping, Quality and Production in an efficient and safe manner. The incumbent is expected to be a self-starter, a good manager of time and be able to work independently. Duties and Responsibilities Approves in-process production by confirming specifications; conducting visual and measurement tests; communicating required adjustments/actions to operator and supervisor Collect representative samples from each production line and perform the required test and/or evaluations to assure that the product meets product specifications. Contain nonconformance raw and finished product as stated in SOP/Work Procedure Manual. Perform and approve first articles after change overs and line start-ups as stated in SOP/Work Procedure Manual. Approves finished products by confirming specifications; conducting visual and measurement tests. Set up and operate various pieces of equipment and instruments in order to perform quality checks/tests on selected samples from production. Document all test and/or quality evaluations and abide by the various operational procedures as spelled out in the SOP/Work Procedure Manual. Maintains safe, secure, and healthy production environment by adhering to organization standards and policies, and to legal regulations; alerting others regarding potential concerns. Ensure that all testing equipment (Magna Mike, scales, etc.) are calibrated on a daily basis; calibration to be completed via us of a calibration gauge, weight or other equipment as needed and recorded on the required check sheet. Creation of Labels as needed for each shift, line, and machine that is in production for that day. Train on the responsibilities of the Inspector Packer role and be able to replace/backup and provide break coverage as needed. Responsible for conducting him/herself in a safe manner and adhering to all required safety protocols and policies. Required to wear PPE properly in accordance with company standards. Keep the area around your workstation clean and free from dirt and debris; this may include cleaning assigned areas of the building or pieces of equipment as instructed by your Supervisor. Follow Plant specified job specifications and task list. Must be able to work assigned shifts, including working overtime and attending after hour meetings as needed. May be required to perform other duties as requested, directed or assigned. Food Safety Duties & Responsibilities Develop and provide training for food safety and quality requirements. Develop and maintain documentation such as SOP’s, as well as maintenance of manuals, policies and procedures as relate to any food safety concerns. Conduct facility food safety audits as well as manage third party audits. Monitor and verify activities to ensure that all products coming in and out of the facility meet food safety standards in addition to quality standards. Update existing food safety procedures and documentation to keep up with changing requirements. Assist buyers with training and educating potential suppliers to ensure compliance. Work closely with Operations Manager and/or General Manager on any food safety or quality assurance issues. Oversee proper maintenance and sanitation of all facility to comply with food safety requirements. Ensure that company food safety and quality assurance procedures are followed and documented correctly at all times. Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Education and Experience High School Diploma or GED preferred 1-2 years of related experience and/or training preferred Experience in plastics or packaging industry a plus Working knowledge of computer operating systems Competencies To perform the job successfully, an individual should demonstrate the following competencies: Productivity - Employee is effective in producing quality products. Employee is efficient and prudent with utilizing resources to meet operational standards, (production, process). Employee has a sense of urgency maximizing time. Teamwork - Employee is capable of being approached and easy to work with. Contributes to the success of the team, communicates clearly individually and in group settings while treating others with respect. Employee listens to others and works well within diverse groups. Employee consistently places team needs over individual needs and seeks input from people with different experiences and perspectives and recognizes the differences of opportunities to learn and gain by working together. Employee values and encourages unique skills and talents. Initiative - Ability to assess and initiate things independently with limited supervision required. Has the ability to manage resources to get things done and the ability to perform multiple activities to accomplish goals doing more than required or requested in the job. Plans ahead for upcoming problems or opportunities and takes appropriate action. Is proactive and anticipates events well in advance to ensure successful outcome. Problem Solving - Employee considers multiple sides of an issue and weighs consequences before making a final decision. Employee makes informed decisions based on available information and recognizes issues and determines what actioned is needed to advance the decision-making process. Employee follows-up as necessary and is easily adaptable to not be discouraged by ambiguous situations and is open to new ideas and processes while adjusting to achieve results. Job Knowledge - Employee demonstrates relevant job knowledge and essential skills, such as work practices, policies, procedures, quality assurance, and technical abilities. Employee demonstrates self-improvement efforts to enhance skills and knowledge with changes impacting the job while adhering to workplace rules as well as to traditional or socially expected methods of doing business following processes and procedures. Safety - Employee demonstrates the ability and willingness to contribute to a safe and environmentally secure work environment for themselves, their coworkers, and our customers by following established safety procedures. Employee demonstrates the willingness to actively report and take action to correct identified safety hazards during the day. Quality - Employee demonstrates the ability to produce high quality, accurate results. Possesses and demonstrates attention to detail and produces work that is accurate and complete. Employee has the ability to identify problems or potential problems that arise in the course of the day and take the necessary steps to proactively address those issues. Employee had the ability to discover the root causes of issues and respond with corrective action. Reliability/Dependability - Employee is responsible and accountable for actions, consistent in meeting deadlines and works well with others to follow through on completing tasks. Employee completes work in a timely, consistent manner and works hours necessary to complete assigned work. Employee is regularly present and punctual and arrives prepared for work. Physical Demands The physical demands described are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to sit, stand, walk, use hands and fingers; talk and hear. Work Environment The work environment is typical of most manufacturing environments. The noise level in the work environment is usually high with ear protection required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the position. Disclaimer The above statements are intended to describe the general nature and level of work being performed by those assigned to a particular position. This document in no way states or implies that this is as an exhaustive list of all responsibilities, duties, and skills required and personnel may be required to perform duties outside their normal responsibilities from time to time, as needed. The Company reserves the right to change, modify, amend, add to or delete from, any section of this document as it deems, in its judgment, to be proper.

Posted 2 weeks ago

QA Engineer-logo
QA Engineer
ImpiricusAtlanta, Georgia
Department: Development Reports To: Senior Director, QA Job type: Full Time, Exempt Who We Are Impiricus is the first and only AI-powered HCP Engagement Engine. Founded by a practicing physician and a senior pharmaceutical executive, Impiricus was created to cut through the noise and put physician care delivery at the forefront. With our unique frontline access to HCPs, their insights, and clinical expertise, we are committed to providing life science companies with innovative channels and AI technology needed to deliver clear, reliable, and evidence-based resources into the hands of HCPs. Guided by a board of trusted physician advisors, we ensure every message leads to better patient care. Welcome to the future of ethical physician and pharma collaboration! Job Summary As a QA Engineer at Impiricus, you will ensure the delivery of high-quality, secure, and reliable software products that meet our users' needs and expectations. You will oversee the end-to-end testing lifecycle, combining manual and automated testing techniques to validate features, identify defects, and ensure compliance with industry standards. In collaboration with cross-functional teams—including product managers, developers, and scrum teams—you will proactively address challenges and advocate for continuous improvement in our Agile environment. Your contributions will directly enhance the user experience and help drive innovation in healthcare technology. Duties/ Responsibilities: Testing and Quality Assurance Design, develop, and execute comprehensive manual and automated test cases across platforms, including web, backend, and mobile applications. Create detailed test plans, test cases, and test scripts to ensure thorough coverage of requirements. Conduct API testing using appropriate tools to validate integration and performance. Identify, log, and track defects through resolution, collaborating with developers to address issues promptly. Perform regression testing, smoke testing, and exploratory testing to validate software stability. Process Improvement and Collaboration Integrate testing processes into CI/CD pipelines to ensure continuous delivery of quality software. Work closely with product managers and development teams to align on requirements and acceptance criteria. Participate in Agile ceremonies, including sprint planning, daily stand-ups, and retrospectives. Monitor and analyze testing metrics to identify areas for improvement in the QA process. Compliance and Documentation Ensure software compliance with industry regulations, including HIPAA, FDA, and GDPR. Maintain comprehensive documentation of test cases, test results, and QA best practices. Provide regular updates to stakeholders on testing progress and results. Experience: Bachelor’s degree in Computer Science, Engineering, or a related field (or equivalent experience). 3+ years of experience in software QA, preferably in the health tech industry. Strong understanding of Agile methodologies and CI/CD pipelines. Experience with manual and automated test planning, development, and execution. Proficiency in scripting languages such as Python, JavaScript, or similar. Familiarity with API testing tools and frameworks. Knowledge of healthcare regulations (HIPAA, FDA, GDPR). (Preferred) Basic SQL skills for database validation and troubleshooting. Proven ability to work in a fast-paced, dynamic environment with minimal supervision. Benefits: Impiricus focuses on taking care of our teammates’ professional and personal growth and well-being. Full support and career-development opportunities to expand your skills, enhance your expertise, and maximize your potential along your career journey; A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act; Generous Total Rewards Plan including comprehensive healthcare (health, dental, vision), life insurance, unlimited PTO, and 401K matching. Impiricus provides equal employment opportunities 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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Posted 1 day ago

Director, QA Clinical Operations-logo
Director, QA Clinical Operations
CatalentHarmans, Maryland
Director, Quality Assurance Clinical Operations Position Summary Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus, featuring two manufacturing facilities is located 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from our Baltimore location. The campus is close to Washington, DC’s I-270 Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse.The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage warehousing. Both facilities support Phase 3 through commercial manufacturing of advanced therapeutic products including AAV and other viral vector-based therapies and vaccines. The Director, Quality Assurance Clinical Operations is responsible for leading and managing quality assurance functions supporting clinical operational activities, ensuring timely and compliant delivery of products while maintaining high-quality standards. The incumbent will oversee real-time batch record review, QA-OTF support, client-facing QA activities, and deviations management. The Director works closely with senior management to meet operational and quality goals and will also be instrumental in ensuring the execution of key deliverables and maintaining the "Patient First" culture. This is a full-time on-site position. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee. The Role Responsible for staffing and overseeing training, effective execution of responsibilities, professional development of employees and conducting performance reviews. Outlines and executes department and business objectives, identifying continuous improvement initiatives, monitors progress of deliverables, and provides support to staff to ensure success. Directs the real-time batch record review activities to ensure product delivery in compliance with applicable regulatory submissions and approvals and within prescribed timelines. Provides investigation direction, support, and department approvals. Ensures investigation CAPA actions are clearly defined, effective in resolving the root causes and are implemented timely. Oversees Client facing personal supporting clinical operations in the roles of Client QA. Directs QA-OTF activities supporting clinical activities including central services and manufacturing operations. Facilitates QA support and works closely with other Catalent functional units including Manufacturing, Validation, Facilities Engineering, and Quality Control to assess and resolve quality issues with regards to the facility and products manufactured. Other duties as assigned. The Candidate Bachelor's degree in science or related field required (Chemistry, Microbiology or Biology preferred). 10+ years of relevant work experience in pharmaceuticals, preferably biotechnology within a Quality role. 8+ years of leadership experience including performance management. Comprehensive and practical working knowledge of applicable GMP regulations, ICH guidelines, FDA guidelines, USP, EP, JP and other applicable regulations and guidance. Knowledgeable and/or exposure to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification, and fill/finish. Exposure to contract manufacturing a plus. Ability to quickly learn new and novel manufacturing processes supporting new clients. Ability to self-direct and adapt to changing priorities. Excellent communication and interpersonal skills required. Strong attention to detail and organization skills required. Why You Should Join Catalent Defined career path and annual performance review and feedback process Diverse, inclusive culture Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives Dynamic, fast-paced work environment Community engagement and green initiatives Generous 401K match and Paid Time Off accrual Medical, dental and vision benefits effective day one of employment Tuition Reimbursement Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE .

Posted 5 days ago

Decima International logo
Mechanical QA Supervisor (On-site) - Dallas, Texas
Decima InternationalDallas, Texas
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Job Description

Decima International is a professional services company, providing project management and controls services to clients in the United States and the Middle East. Our mission is to become the premier professional services provider across all industry sectors we are engaged in. To accomplish this, Decima International’s founders established a simple yet powerful formula:

Approach each client engagement as a partnership, create an environment that attracts the most talented professionals and allows them to flourish, and regulate growth to maintain excellence in our service standards.

If you are interested in a long and rewarding career working with high-profile clients on some of the most challenging projects in the world, then Decima is where you belong. At Decima, you will be able to explore incredible growth and professional development opportunities.

We are looking for a driven and capable Mechanical QA Supervisor to support us with the development of multiple hyperscale data center projects for one of our top technology clients. This is a client-facing role that requires strong interpersonal, communication and organizational skills, ability to self-direct, client representation, and an emphasis on strong project management fundamentals. Must be able to manage multiple projects concurrently. A strong background in data center development, design, engineering, controls, and operations requirements is a big plus. 

You will play an integral role in ensuring the development and implementation of the Quality Management System (QMS) in addition to the coordination, performance, and completion of all construction audits and commissioning services of the project. The Mechanical QA Supervisor is accountable for the quality of work performed, compliance with building codes, safety regulations, as well as meeting the project’s contractual requirements set forth by the client.  

We are looking to bring in dedicated individuals with a passion for innovation and talent for multitasking in a fast-paced environment. We will help you grow, pursue, and fulfill what inspires you so we can make big impacts on the world, together. 

RESPONSIBILITIES

  • Understand the project scope and requirements.
  • Ensure compliance with quality standards, building codes, safety regulations, and environmental guidelines.
  • Review and verify material submittals for A/E and Client approval.
  • Confirm delivered materials match approved submittals.
  • Manage and review submittals, RFI logs, maintenance logs, and other project documents promptly.
  • Update QC punch lists and coordinate with general contractors (GC) and subcontractors for completion.
  • Conduct internal quality audits and site inspections.
  • Adhere to Quality, Health, Safety, & Environment (HSE) standards.
  • Provide technical support to address operational challenges and client concerns.
  • Plan and inspect Definable Features of Work (DFWs).
  • Develop and implement Audit and Test Plans for quality inspections and testing.
  • Maintain and update Quality manuals, checklists, and forms.
  • Collaborate with third-party QA/QC firms as needed.
  • Participate in Quality Management System (QMS) audits.
  • Build relationships with project partners, consulting engineering firms, public agencies, and clients.
  • Ensure document control compliance and maintain project submittal logs and quality control reports.
  • Verify and document material compliance with approved submittals.
  • Compile and forward project closeout documents, including O&M manuals, as-builts, and warranties.
  • Investigate and address non-conformance issues promptly.
  • Ensure calibration of inspection, measurement, and test equipment.
  • Liaise with the General Contractor, Client, and Project Management team to resolve quality issues.
  • Prepare presentations on progress, findings, and recommendations for management.
  • Review subcontractors’ submittals for compliance.
  • Coordinate and monitor subcontractors, suppliers, direct labor, and materials.
  • Collaborate with public utility suppliers for final service connections.
  • Coordinate activities of inspection agencies.
  • Achieve required MEPS and electromechanical inspections.
  • Assist in preparing periodic QA/inspection progress reports.
  • Review and approve subcontractor work percentages.
  • Oversee commissioning processes.
  • Manage the MEP project closeout to ensure all requirements are met.

QUALIFICATIONS

Required Qualifications:

  • 15+ years of construction and quality management experience. 
  • Bachelor’s degree in mechanical, electrical engineering, or a related field. 
  • Experience with managing field engineering, inspection, and NDE related to all QA/QC functions.
  • Proficient with reading, understanding, and interpreting plans, specifications, drawings, contracts, and other documents pertaining to MEP aspects of projects.
  • Ability to develop and manage non-conformance, defects, and reporting programs, including root cause analysis.  
  • Ability to ensure correct codes, standards, job specifications, project procedures, and federal and provincial regulations are properly identified, correctly specified in detail, and met or exceeded. 
  • Ability to work in high-production environments and respond quickly and effectively under pressure and deadlines while maintaining a professional demeanor. 
  • Technical knowledge of materials and construction concepts.
  • Experience working as a Mechanical Quality Supervisor for large commercial, industrial, or mission-critical facilities construction projects. 
  • An excellent understanding of construction Quality Management Systems (QMS). 
  • Familiarity with punch list procedures and project closeout processes.
  • Strong attention to detail and excellent analytical skills.
  • Strong knowledge of high, medium, and low-voltage systems, HVAC, control systems, commissioning, LEED/Green building projects, and general ground-up construction projects as applicable to MEPS.  

Preferred Qualifications:

  • Project Management Professional (PMP) certification.
  • Construction Quality Manager Certification (CCQM)
  • US Army Corps of Engineers (USACE)
  • Certified Quality Auditor (CQA)
  • Member of the American Society for Quality
  • Six Sigma Certifications
  • ISO 9001
  • Green Business Certification (LEED)
  • Strong background in data center development and construction

 

POSITION DETAILS:

  • Primary Location: Dallas, Texas
  • Position: Mechanical QA Supervisor
  • Position Classification: Salary-based full-time regular hours
  • Travel: 10% travel expected
  • Current US work permit required. This position does not offer sponsorship for employment (e.g., H-1B visa sponsorship or transfer not offered)

 

PRODUCTIVITY TOOLS:

  • Microsoft Office
  • Microsoft 365
  • CxAlloy

 

Job Type: Full-time

Schedule: 8-hour shift

Work Location: (On-site)

  • Dallas, Texas

 

Decima International is an Equal Opportunity Employer who is committed to the safety and wellbeing of all. All qualified applicants will receive consideration for employment without regard to race, religion, creed, color, national origin, ancestry, sex (including pregnancy, childbirth, breastfeeding, or medical conditions related to pregnancy, childbirth, or breastfeeding), age, medical condition, marital or domestic partner status, sexual orientation, gender, gender identity, gender expression and transgender status, mental disability or physical disability, genetic information, military or veteran status, citizenship, low-income status or any other status or characteristic protected by applicable law.

At Decima International, we offer a competitive salary package, including paid time off and performance-based bonuses. We also provide excellent medical, vision and dental insurance for our employees.