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Thermo Fisher Scientific logo
Thermo Fisher ScientificGreenville, North Carolina
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description The Staff QA Engineer will lead the quality oversight of validation activities with a strategic focus on continuous improvement and regulatory compliance. This senior-level position involves leadership, mentorship, and high-level coordination of validation processes across multiple sites. Typical work hours are Monday- Friday from 8a- 5p, but the role also requires this individual to have on-call weekends based on a predefined schedule for urgent off-hours questions. Key Responsibilities: Lead QA validation activities related to Facilities, Utilities, Engineering, Quality Control, and Operational equipment. Provide strategic quality oversight of facility and equipment commissioning and other activities. Review and approve: Equipment Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ) protocols and reports. Validation related deviations and discrepancies. Process Validation (PV), Cleaning Validation, and Computer System related protocols and reports. Lead QA support for risk assessment, FMEA, and change controls governing validation related activity. Coordinate and lead validation activities with multi-functional team members to ensure efficiency and compliance with regulations. Develop and maintain a safety and quality culture. Mentor and train junior QAV Engineers. Drive continuous improvement initiatives in validation processes. Qualifications: BS/BA in a scientific or related field required, preferably in Biology/Chemistry or Engineering. Advanced degree preferred. 5+ years of experience in Quality and/or Validation. 7+ years of cGMP experience in the pharmaceutical industry, Steriles manufacturing experience strongly preferred. Proven ability to lead and mentor multi-functional teams. Strong leadership skills and ability to work within a matrix organization. Ability to support and lead multi-functional and multi-site initiatives involving integration. Excellent written and oral communication skills; ability to communicate effectively with Senior Leadership and all levels below. Ability to prioritize, align and simplify, demonstrate enthusiasm, take accountability and drive for results. In-depth knowledge of cGMPs, technical writing, data management collection, and analysis. Exceptional interpersonal skills, including teamwork, facilitation, and negotiation. Ability to work independently, with a pro-active mentality to mitigate risk We offer competitive salary, an annual incentive bonus plan, 401K with company match up to 6%, tuition reimbursement and a range of other employee benefits! We foster an exciting company culture that encourages innovation, forward-thinking, and an outstanding career and development prospects. Come be a part of the team!

Posted 2 weeks ago

2nd Swing logo
2nd SwingEden Prairie, Minnesota

$65,000 - $95,000 / year

Come work with us, not for us! 2nd Swing is a one of a kind, forward thinking, customer-centric golf retail company. Our employees are highly-valued, while working hard in a positive and supportive culture. At 2nd Swing you will find: Vast Exposure to the Golf Industry A Commitment to Total Well-Being Opportunities to Discover Your Fit and Make an Impact A Collaborative and Flexible Environment Position Summary: 2nd Swing is seeking an experienced QA - Ecommerce professional with a passion for golf to join our team! As a QA - Ecommerce professional on our team, you will play a key role in growing the 2nd Swing Golf web presence across multiple channels and platforms. This position will collaborate with our development and IT teams including developers, business analysts, designers, and project managers to create new and/or improved business solutions. The ideal candidate will have a strong understanding and enthusiasm for the game of golf, experience working with NetSuite and Magento platforms, and demonstrated success in problem-solving and learning new systems. Responsibilities: Learn development standards and work to enhance our websites, NetSuite, and integration routines. Work with Developers to ensure end-to-end and integration automated testing for key applications including the Magento platform. Create comprehensive test plans in tabular format, with clear, granular, and uniquely identified test cases. Provide guidance on QA processes and help establish best practices for the build, test and deploy cycles. Work independently and as part of a team. Self-motivated work style with the ability to research solutions and learn new systems. Qualifications: Associates degree or equivalent in MIS, Computer Science, or related area. Basic knowledge in programming languages such as java, python or similar. Excellent verbal, written, and interpersonal communication skills. Proven analytical skills with high attention to detail and accuracy. Preferred Qualifications: Proficiency in API endpoint testing, including building payloads and reviewing responses. Strong knowledge of Chrome DevTools for debugging and performance analysis. Previous experience in an eCommerce QA role. Familiarity with web quality analysis tools such as Lighthouse or similar platforms. Hands-on experience with automated testing tools like Selenium, Playwright, or equivalent. Understanding of web accessibility standards (WCAG) and related testing tools. Experience using JIRA for issue tracking and project management. Genuine interest in and knowledge of the game of golf. Physical Requirements: Prolonged periods of sitting at a desk. Comfortable working in an office environment. Full-Time Benefits: Employee Programs such as PGA membership dues support Paid Time Off 401k company match Health Insurance HSA/FSA Discounted Merchandise Continued Training and Development Health and Wellness Initiatives Work Life Balance Compensation: $65,00 - $95,000 annually Compensation will be based on experience, qualifications, and overall fit for the role. Candidates with stronger industry experience or advanced skill sets may be considered at the higher end of the range.

Posted today

Axsome Therapeutics logo
Axsome TherapeuticsNew York, NY
Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X . About This Role Axsome Therapeutics is seeking a Manager/Senior Manager, QA Operations, responsible for ensuring compliance with Good Manufacturing Practices (GMP) with all work performed. The Manager/Senior Manager, QA Operations will contribute towards the enhancement of Axsome quality processes and ensures appropriate QA oversight of suppliers (CDMOs and GMP-related service providers) contracted for the development, manufacturing, testing, shipment and/or distribution of API and finished products to assure compliance with company procedures, FDA/EEA/Health Canada regulations and assists with tasks necessary to achieve department and/or company goals. This role is based at Axsome’s HQ in New York City with an on-site requirement of at least three days per week. We are unable to consider candidates who are looking for fully remote roles. Job Responsibilities and Duties include, but are not limited to, the following: Assist with development and/or implementation of corporate quality management systems that support clinical-stage R&D and commercial programs Interact closely with Quality Systems & Compliance to champion continuous improvement and garner corporate support for Quality Improvement Initiatives Support the development of key performance indicators (KPIs) to measure and report operational performance of CMOs, recommending data-driven decisions to optimize processes Responsible for all aspects of QA Operations, including review and approval of cGMP-related documentation (SOPs, batch records, validation protocols, technical reports, specifications, deviations, CAPA, change controls, APQR) and resolve discrepancies as needed Identify and address compliance issues to ensure Axsome’s QMS is maintained in a state of inspection readiness Serve as a Quality liaison between Axsome and suppliers Serve as an escalation point for CMO quality issues with regards to investigations, nonconformances, deviations, and CAPA Alerts senior management of significant quality, compliance and supply risks Collaborate with internal cross-functional teams to identify and address quality issues develop corrective action plans, and implement process improvements Collaborate with external partners, including suppliers, vendors, and regulatory agencies, to ensure that our products and services meet all quality requirements Develop, review or revise Standard Operating Procedures (SOPs), Work Instructions (WI) and other controlled documents Builds and maintains a robust Operations team by providing effective communication, motivation, mentorship and performance feedback Participate in vendor audits and site visits, as needed Requirements / Qualifications Bachelor of science degree highly preferred, preferably in a scientific discipline At least 6 years of experience working in a pharmaceutical QA function with 3+ years of QA management/oversight of contract operations Up to 20% domestic and international travel may be required Ability to work on site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote roles Experience, Knowledge and Skills 1+ years managing/supervising a QA team is preferred Experience working with CDMOs and relationship management preferred Strong hands-on knowledge of API and drug product (oral solids) manufacturing processes Strong knowledge of FDA/EEA/HC regulations, ISO and other applicable quality standards Strong attention to detail and excellent organization skills Excellent interpersonal, communication (verbal/written) and negotiation skills Comfortable multi-tasking in a fast-paced small company environment and able to navigate through ambiguity and rapid growth and adapt to change Proven track record of success in developing and implementing quality policies and procedures, conducting audits and leading cross-functional teams Salary & Benefits The anticipated salary range for this role is $120,000 - $145,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package. Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law. Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration.

Posted 30+ days ago

Tencent logo
TencentIrvine, California

$17 - $37 / hour

About the Hiring Team Welcome to Lightspeed LA, the first U.S.-based, AAA game development studio for Tencent Games. Lightspeed LA is focused on building open-world games that emphasize an ambitious living world, sophisticated player-driven gameplay, and mature, thoughtful storytelling. We are developing the first in a series of genre-defining titles.Why join Lightspeed LA?For us, it's not only about the exciting, new AAA open world game we're developing but also about team values and studio culture. We foster an open and transparent environment where everyone feels comfortable providing constructive feedback about all aspects of our games.●* We encourage the showing of work that's still in progress.●* We don't attack or question unfinished work, we celebrate its promise.●* We have a No Blame Culture where we blame the problem, not the person.This is a safe place to fail, and we don't view failure as a negative, but as the natural result of pushing boundaries and trying new things. We create together. We face Challenges Together. We succeed together. What the Role Entails Lightspeed LA is seeking a QA Tester earnest about working on a new project in Irvine, California. They will get to flex their QA muscles and apply their skills on a AAA open world project. The ideal candidate to join our team will have a mixture of experience to draw from, drive for growth, and passion for games and QA. This is an exciting opportunity to have an impact on a fully original title, grow professionally, and make valued relationships. Consider a new chapter in your career with a studio that cares about maintaining a positive company culture as you perform your craft and have fun while doing it. Responsibilities: Functional and Non-Functional testing. Write up bugs and be able to work in a bug tracking database. Participate in test planning with insights to testing approach, scope, and schedule. Track metrics and identify quality issues to report them regularly. Document information efficiently on a database wiki. Communicate QA findings, updates, and assessments with relevant stakeholders or team members. Collaborate effectively with all team members in person or remotely to achieve tasks. Maintain expertise in parts of our game, development processes, or tools in support of the project. Utilize and design automation test setups that can scale with project needs. Who We Look For Passion for video games with experience and knowledge you can draw upon. 1-3 years of QA testing experience on video games. Experience working in a bug database. Strong written and oral communication skills while utilizing strong interpersonal skills. Pluses QA testing experience with games, especially consoles, and 1st party certification testing. Worked through an entire development life cycle on at least one project. Familiarity with using any game engine, programming, scripting, or automating tests. Experience with effectively using a wiki to share knowledge efficiently. Experience collaborating directly with developers Why Join Us? Location State(s) US-California-IrvineThe expected base pay range for this position in the location(s) listed above is $16.66 to $36.50 per hour. Actual pay may vary depending on job-related knowledge, skills, and experience. Employees hired for this position may be eligible for a sign on payment, relocation package, and restricted stock units, which will be evaluated on a case-by-case basis. Subject to the terms and conditions of the plans in effect, hired applicants are also eligible for medical, dental, vision, life and disability benefits, and participation in the Company’s 401(k) plan. The Employee is also eligible for up to 15 to 25 days of vacation per year (depending on the employee’s tenure), up to 13 days of holidays throughout the calendar year, and up to 10 days of paid sick leave per year. Your benefits may be adjusted to reflect your location, employment status, duration of employment with the company, and position level. Benefits may also be pro-rated for those who start working during the calendar year. Equal Employment Opportunity at Tencent As an equal opportunity employer, we firmly believe that diverse voices fuel our innovation and allow us to better serve our users and the community. We foster an environment where every employee of Tencent feels supported and inspired to achieve individual and common goals.

Posted today

Kenvue logo
KenvueFort Washington, Washington

$71,400 - $100,800 / year

Kenvue is currently recruiting for a: Analyst 2, External Manufacturing QA What we do At Kenvue , we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent. Who We Are Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated.We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours. For more information , click here . Role reports to: Quality Account Manager Location: North America, United States, Pennsylvania, Fort Washington Work Location: Fully Onsite What you will do The Quality Analyst II is responsible for performing key activities related to the retain management, manufacturing, packaging, testing, and release of the portfolio of US Self Care drug products in the external supply chain of Kenvue. This role represents External Manufacturing Quality Assurance (EMQA) on projects and improvement teams to guide quality/compliance requirements, develop and update procedures, and provides support to the Quality Leads and Account Managers for products produced across our network. This is a fully onsite position in Fort Washington, PA. Key Responsibilities: Support the processing of retention samples from external packaging sites.Support EMQA Quality Leads and Quality Account Managers through various projects and quality/compliance improvement activities and change controls within EMQA.Support batch record review and batch disposition for US Self Care drug products from external manufacturing and packaging sites.Support EMQA as a Tru admin with uploading documents in Tru What are we looking for Qualifications: Education: Minimum of a Bachelor’s degree required ; focused degree preferred in Engineering, Life Science, Physical Science, or related subject area Experience and Skills: Required: Minimum 2 years of relevant work experienceExperience in FDA-regulated pharmaceutical Quality or Supply Chain roleSolid understanding of cGMPsSolid understanding of Quality Assurance principles and practices in the pharmaceutical, medical device, biological, and/or OTC Drug product industry Preferred: Familiarity with LIMS & SAPSolid understanding of site quality activities (batch record review, product release, change control)Advanced proficiency with Microsoft Excel (e.g., VLOOKUPS and pivot tables)Experience working on cross-functional project teams What’s in it for you Annual base salary for new hires in this position ranges: $71,400.00 - $100,800.00 This takes into account a number of factors including work location, the candidate’s skills, experience, education level & other job-related factors. Competitive Benefit Package* Paid Company Holidays, Paid Vacation, Volunteer Time & More! Learning & Development Opportunities Kenvuer Impact Networks This list could vary based on location/region *Note: Total Rewards at Kenvue include salary, bonus (if applicable) and benefits. Your Talent Access Partner will be able to share more about our total rewards offerings and the specific salary range for the relevant location(s) during the recruitment & hiring process. Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on merit without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.

Posted today

Thermo Fisher Scientific logo

Staff QA Engineer

Thermo Fisher ScientificGreenville, North Carolina

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Job Description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

The Staff QA Engineer will lead the quality oversight of validation activities with a strategic focus on continuous improvement and regulatory compliance. This senior-level position involves leadership, mentorship, and high-level coordination of validation processes across multiple sites. Typical work hours are Monday- Friday from 8a- 5p, but the role also requires this individual to have on-call weekends based on a predefined schedule for urgent off-hours questions.

Key Responsibilities:

  • Lead QA validation activities related to Facilities, Utilities, Engineering, Quality Control, and Operational equipment.

  • Provide strategic quality oversight of facility and equipment commissioning and other activities.

  • Review and approve:

    • Equipment Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ) protocols and reports.

    • Validation related deviations and discrepancies.

    • Process Validation (PV), Cleaning Validation, and Computer System related protocols and reports.

  • Lead QA support for risk assessment, FMEA, and change controls governing validation related activity.

  • Coordinate and lead validation activities with multi-functional team members to ensure efficiency and compliance with regulations.

  • Develop and maintain a safety and quality culture.

  • Mentor and train junior QAV Engineers.

  • Drive continuous improvement initiatives in validation processes.

Qualifications:

  • BS/BA in a scientific or related field required, preferably in Biology/Chemistry or Engineering. Advanced degree preferred.

  • 5+ years of experience in Quality and/or Validation.

  • 7+ years of cGMP experience in the pharmaceutical industry, Steriles manufacturing experience strongly preferred.

  • Proven ability to lead and mentor multi-functional teams.

  • Strong leadership skills and ability to work within a matrix organization.

  • Ability to support and lead multi-functional and multi-site initiatives involving integration.

  • Excellent written and oral communication skills; ability to communicate effectively with Senior Leadership and all levels below.

  • Ability to prioritize, align and simplify, demonstrate enthusiasm, take accountability and drive for results.

  • In-depth knowledge of cGMPs, technical writing, data management collection, and analysis.

  • Exceptional interpersonal skills, including teamwork, facilitation, and negotiation.

  • Ability to work independently, with a pro-active mentality to mitigate risk

We offer competitive salary, an annual incentive bonus plan, 401K with company match up to 6%, tuition reimbursement and a range of other employee benefits! We foster an exciting company culture that encourages innovation, forward-thinking, and an outstanding career and development prospects. Come be a part of the team!

Automate your job search with Sonara.

Submit 10x as many applications with less effort than one manual application.

pay-wall