Vice President GxP Quality and Compliance
Remote Lead Quality Control Job
About Us:
Modicus Prime's mission is to improve the quality of pharmaceutical drug manufacturing and save patient lives by leveraging the power of AI and advanced analytics. Our AI platform solves for the cost, legal, and waste liabilities from product quality failures across pharmaceutical R&D and manufacturing. Modicus Prime is a Johnson & Johnson JLABS company and venture-backed by Austin-based Silverton Partners along with strategic partnerships with many large corporations including Takeda Pharmaceuticals, Oak Ridge National Laboratory (DOE), eLabNext (Eppendorf), Dotmatics, and PlugandPlay. Modicus Prime was most recently featured in the Wall Street Journal on July 18th, 2024, following our latest investment announcement.
We are now seeking a Vice President of GxP Quality and Compliance to join our company. If you are eager to impact the AI/ML integration in the pharmaceutical industry and enjoy rapidly scaling products and teams, consider applying to join our company.
Position Overview and Key Responsibilities:
As the VP of GxP Quality and Compliance, you will ensure that all software development, deployment, and operational processes align with Good Manufacturing Practices (GMP) and comply with the latest regulatory standards. Collaborating closely with engineering, quality assurance, regulatory, and leadership teams, you will embed compliance into workflows while driving operational excellence in highly regulated environments.
This role requires a cross-functional understanding of regulatory practices, particularly those governing the deployment of AI/ML-powered software solutions. You will build upon the company's GxP compliance strategy, ensuring alignment with regulatory requirements, including FDA and EMA guidelines. Additionally, you will train and mentor both our team and our customers on GxP requirements related to AI/ML utilization, fostering a culture of compliance and quality excellence. Furthermore, you will oversee the creation, implementation, and monitoring of policies and procedures to ensure GxP compliance across all software development and deployment activities.
A key aspect of your role will involve supporting our customers in understanding and implementing a wide range of AI/ML software solutions within a GxP environment. You will provide expertise to help them navigate regulatory challenges and effectively deploy compliant AI/ML models using our software. By staying informed of regulatory changes and emerging trends in GxP compliance, you will proactively adapt company strategies and practices to maintain industry leadership.
You will also represent the company as a subject matter expert in GxP compliance during client engagements, industry forums, and regulatory interactions, ensuring our solutions meet the highest standards and foster customer trust.
This role is U.S.-based, and visa sponsorship cannot be accommodated at this time.
Basic Qualifications:
10+ years of experience in regulatory compliance roles within the pharmaceutical or biotech industries.
Proven experience in leading cross-functional teams of engineers, quality assurance professionals, and regulatory experts to develop and implement strategies for AI/ML system validation in compliance with GxP standards.
Extensive knowledge of GxP guidelines, including 21 CFR Part 11, GAMP 5, and EMA guidelines.
Proven expertise in computer system validation (CSV) and experience managing validation processes for software in regulated environments.
Strong understanding of GxP-compliant software development lifecycles, including change control and risk management.
Bachelor's or Master's degree in Life Sciences, Computer Science, Regulatory Affairs, or a related field.
Proven experience with AI/ML systems and their validation in GxP environments.
Experience with cloud-based GxP-compliant systems, such as AWS or Google Cloud.
Certifications such as Certified Quality Auditor (CQA) or Certified Software Quality Engineer (CSQE).
Additional Information:
1. Location: Austin preferred
2. Job Type: Full-time
3. Pay (with equity): $200k - $220k depending on skills and/or qualifications
What We Offer:
Enjoy the benefits of a flexible work schedule within a remote working environment, while also having the opportunity to connect with your colleagues through regular in-person meetings in Austin, including team luncheons.
The chance to lead groundbreaking AI initiatives that are transforming the pharmaceutical industry.
A supportive and collaborative team culture, with ample opportunities for professional growth and development, including conference speaking opportunities.
Equal Opportunity Employer Statement:
We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or protected veteran status.
To Apply:
Please submit your CV and any relevant materials to
*********************
. We look forward to hearing from you and exploring how your ambitions and expertise can help shape the future of Modicus Prime and the pharmaceutical industry at large.
QA/QC Manager
Lead Quality Control Job In Ashburn, VA
Datacenter People is a specialised recruitment company working with the leading data center commissioning and quality services firms in the world.
Our client serves as an owner's representative, specialising in Data Center commissioning and QA/QC services.
The Role
Actively supports the Company's commitment to safety and its core values.
Performs quality inspections in accordance with program quality control documentation. Participate and guide project quality control from kick-off until hand-off.
Provides oversight of the implementation of the QA/QC management system at site.
Coordinates the quality inspections with the site sub-contractors and vendors.
Coordinates with the customers representative on all quality matters.
Provides oversight in the distribution of relevant QA/QC documentation to site subcontractors while reviewing that completed documentation is stored appropriately upon completion.
Verifies that the quality related site activities are in accordance with the design documents and program standards.
Participates in the internal and external site audits.
Coordinates all the quality site inspections through the Contractor QC team.
Ensures all quality control documentation is compiled and competed for as-built hand over through the Contractor QC team.
Provide review and reporting of all non-conformance reports and undertake remedial action. Monitors the implementation of the approved site QC Plan.
Completes and coordinates the approval of the sites QC technical submittals to the customer.
Coordinates with the Client and Contractor QA/QC team on all quality issues.
Coordinate and chair the QA/QC site weekly meetings with the Contractor QC personnel.
Assures all technical documents relative to site quality control are of current status.
The Experience Profile
Has data center commissioning/QA experience.
Has a history and experience driving improved Quality at scale.
Is able to work seamlessly across functional and department lines.
Has experience with standard data center equipment to include: electrical distribution equipment from switchgear to panelboards, VFDs, low voltage power and moulded case circuit breakers, overhead IT busway, Diesel Generators, DX units, air handlers, water treatment equipment, BMS modules, and hot aisle containment accessories.
Is able to travel domestically and internationally as needed.
We regret that due to the high volume of applications we are unable to acknowledge each one. Please bear in mind that if you are selected for interview we will contact you within the next seven days.
Manager, QA and QC
Lead Quality Control Job In Gaithersburg, MD
This position is a key member of the Elutia team and as such is involved in setting the Company's short to medium range goals and objectives as it relates to quality assurance. The Manager of Quality Assurance & Quality Control is responsible for overseeing and maintaining the Elutia quality system and process compliance activities, on a daily basis including the monitoring of inspectional activities and dispositioning of non-conforming products. Interacts directly with internal and external customers on product release activities as needed. In addition, this individual will play an integral role in coordinating activities across departments to achieve desired growth and establish corporate goals in an entrepreneurial environment. For example, this leader will partner with operations to ensure compliance with applicable procedures. This position will be located on-site in the Company's Gaithersburg, MD facility.
Essential Duties & Responsibilities:
• Review and approve applicable document change orders.
• Assist management in developing strategic regulatory approaches for new product/business development.
• Oversee the day-to-day activities related to the quality and safety of tissue products and processes.
• Establish and assist with the implementation of quality systems and system improvements.
• Ensure necessary corrective and/or preventive actions are taken in accordance with established procedures.
• Lead continuous improvement activities.
• Monitor regulations, standards, policies, and guidance issued by relevant regulatory authorities for changes that may impact the company and disseminates information accordingly.
Education & Experience:
· BA or BS in the life sciences or a related degree program
· A minimum of 5 years in a management role with extensive quality experience in an FDA-regulated environment, with knowledge of 21 CFR Part 1271, Human Cells, Tissues, and Cellular and Tissue-Based Products (HTC/P) preferred.
· Experience successfully interfacing with accreditation agencies (ISO, AATB), writing responses and other documents required in a regulated environment.
· Strong leadership skills; demonstrated ability to clearly develop and articulate short-term goals and objectives to drive performance and results
· Ability to juggle multiple tasks and prioritize work appropriately with a focus on timelines and deliverables
· Strong communication (written, oral and interpersonal) and presentation skills. Must have demonstrated experience presenting to diverse audiences including Internal (leadership team, employees) and external (Company executives, operations & purchasing teams)
· Excellent judgment and decision-making capabilities; must be able to formulate business solutions to a myriad of challenges
· Ability to work collaboratively with various internal departments and leaders
· Ability to drive results through partnership, mutual respect, and trust
Director of Quality Control
Lead Quality Control Job In Columbia, MD
The Director of Quality control plays a vital role in maintaining the quality and excellence of Niche Polymer (group of businesses) products and services. This individual will be located at our corporate office, but oversee Quality Control at Various facilities. The most notable facilities being; Nesquehoning, PA; Ravenswood, WV; and Washington, WV.
Ensuring high-quality operations and products and services across our organization is the critical role of the Director of Quality Control. This position demands a keen eye for detail, effective leadership skills, and a comprehensive knowledge of quality control processes. TheDirector of Quality Control will supervise all quality control activities within the organization and will collaborate with cross-functional teams to establish and sustain efficient quality control standards. This individual must have a background in Polymers or similar.
General Responsibilities:
Develop and implement quality control strategies, policies, and procedures to ensure consistent delivery of high-quality products or services.
Lead and manage a team of quality control professionals, providing guidance, training, and support.
Establish and monitor key performance indicators (KPIs) to track the effectiveness of quality control processes and identify areas for improvement.
Collaborate with cross-functional teams, such as production, operations, and customer service, to ensure quality control standards are integrated into all aspects of the organization.
Conduct regular audits and inspections to identify areas of non-compliance or opportunities for improvement.
Develop and implement corrective and preventive actions to address quality control issues and prevent recurrence.
Stay up-to-date with industry trends, standards, and regulations related to quality control and incorporate best practices into the organization's processes.
Analyze data and metrics related to quality control to identify trends, patterns, and areas for improvement.
Establish and maintain relationships with suppliers and vendors to ensure compliance with quality control standards.
Collaborate with the Research and Development team to ensure new products or processes meet quality standards before they are introduced to the market.
Minimum Requirement:
Quality procedures and practices
Proficient in technical writing
Ability to communicate with customers
Leadership skills
Travel will be mandatory to WV and PA. Expected travel is 2 trips per month or as needed for customer visits.
Manufacturing processes and quality controls
Industries: Compounding, Injection Molding
Advanced degree in Engineering and/or a Polymer science degree
No VISA Sponsorship
PHYSICAL DEMANDS: The physical demands described here 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; use hands to finger, handle, or feel and talk or hear. The employee is occasionally required to stand and walk.
Quality Manager
Lead Quality Control Job In Falls Church, VA
DHS Quality Manager
Xcelerate Solutions is seeking a Quality Manager to work our DHS Programs in Falls Church, VA. Candidates MUST have an active TOP SECRET level security clearance to be considered. Come join our award-winning organization and work with the most talented and brightest minds in the GovCon industry.
Location:
Falls Church, VA (Hybrid- On Site)
Clearance:
Top Secret
Responsibilities:
Assist the Quality Assurance Officer with meeting the monthly requirements of the DHS Quality Control Contact program (QCC). The QCC program requires contact to be made with interviewed persons and asking quality-related questions regarding their interview experience with our investigator. Should an issue arise with the source's experience, the issue is recorded and forwarded to the Quality Assurance Officer.
Maintain an organized record of all calls made, all issues tracked, and all deliverable reports assembled, processed and submitted.
Assist with resolving lower-level issues which result from QCC calls.
Assist with other deliverables as needed.
Provide verbal counseling as needed to investigators under the direction of the Quality Assurance Officer in order to resolve issues that arise from the QCC program or other parts of the DHS contract.
Maintain awareness of deliverable-related timetables and organize themselves accordingly so as to meet monthly deadlines successfully.
Minimum Requirements:
Six (6) or more years of experience in the personnel security investigations or background investigations industry
DHS Credentialed Investigator
Bachelor's degree from an accredited college or university
Highly organized with the ability to work independently and efficiently.
Strong sense of responsibility for deadlines and mission completion.
Strong writing skills with the ability to adapt to government-approved formats.
Preferred Qualifications:
Professional background related to DHS personnel security background investigations.
Understanding of client-vendor relationships and expectations.
Experience with retraining and/or counseling individuals.
Proficiency with MS Word and MS Excel.
About Xcelerate Solutions:
Founded in 2009 and headquartered in McLean, VA, Xcelerate Solutions (*************************** is one of America's fastest-growing companies. Xcelerate's culture is defined by our diversified workforce of dynamic and versatile professionals, supported with growth and development opportunities that contribute to individual and company growth. This strong commitment to our employees has been recognized by our inclusion on the Washington Business Journal's “50 Best Places to Work” list as well as being a “Great Place to Work” certified company with a 4.6 star, and a 99% CEO approval Glassdoor rating. Come find out why Xcelerate Solutions is one of the DC Metro top employers!
Xcelerate Solutions is an Equal Employment Opportunity/Affirmative Action Employer. We evaluate qualified applicants without regard to race, color, national origin, religion, age, equal pay, disability, veteran status, sex, sexual orientation, gender identity, genetic information, or expression of another protected characteristic. As part of this commitment to the full inclusion of all qualified individuals, Xcelerate provides reasonable accommodations if needed because of an applicant's or an employee's disability.
Pay Transparency Notice: Xcelerate Solutions will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.
QA Manager
Lead Quality Control Job In Bethesda, MD
Piper Companies is looking for a QA Manager to join a clinical pharmaceuticals company located in Bethesda, MD. Responsibilities of the QA Manager include:Complete communication with both internal and external vendors Create new SOPS and improve existing ones Deal with quality records through initiation, tracking, and closure (Ex: Deviations, Change Controls, CAPAs, Out of Specification records) Complete reviews of manufacturing batch records Qualifications for the QA Manager include:B.
S with 5+ years of experience in GCP environment Bachelor's or Master's degree in the Scientific field Compensation for the QA Manager includes:Rate Range: $115,000 - $130,000 Per Year Comprehensive Benefit Package: Health, Dental, and Vision, 401K, Sick Leave as required by law This job opens for applications on 2/10/2025.
Applications for this job will be accepted for at least 30 days from the posting date.
Keywords: Quality Assurance, Quality Assurance Associate, Quality Assurance Analyst, SOP, Supplier Audits, MasterControl, Batch Records, Deviations, Change Controls, CAPAs, Out of Specification, OOS, Document Control#LI-AS1#LI-ONSITE
Construction Quality Control Manager
Lead Quality Control Job In Leesburg, VA
Miami Wiipica is a SBA certified, tribally owned 8(a) and qualifies as a Small Disadvantaged Business. Wiipica is dedicated to serving federal customers in construction, operations and maintenance, design/build, engineering, studies and remediation, and commissioning projects. Wiipica has the infrastructure and assets to support a variety of projects in diverse geographic locations, from design to close out. Our customers include the Department of Defense (including US Army Corps of Engineers), and the General Services Administration. Miami Wiipica works on projects nationwide.
Miami Wiipica offers excellent benefits including employer-paid premium medical insurance, dental, vision, generous PTO and paid holidays, and competitive 401(k) matching.
Overview:
Miami Wiipica is currently seeking a Quality Control Manager (CQC) to serve on a project team for an anticipated multi-year contract. No security clearance is required for this position, but ability to pass a background check is required to gain access to the worksite. Work will be completed in Leesburg, VA.
We are seeking a highly organized and detail-oriented Quality Control Manager to ensure the highest level of quality throughout our entire organization. This role is responsible for developing and implementing quality control processes, evaluating existing processes and identifying areas of improvement, and ensuring compliance with all regulatory standards. The Quality Control Manager will also develop quality assurance systems, monitor performance, and provide feedback.
Responsibilities include:
Act as Construction Quality Control Manager at the work site to implement and manage the project specific Contractor Quality Control Plan.
Provide overall coordination of the construction quality management program for assigned projects, plus provide regular and timely status reports to the Government sponsor about the status of these construction projects under your administrative and technical control
In conjunction with the Government Construction Manager (CM), review and provide recommendations toward approval of contractor-submitted quality control plans.
Provide relevant remarks on Government Quality Assurance (QA) reports or in identified sections of various Contractor's Quality Control (QC) reports, particularly remarks about critical, definable features of work included.
Validate quantity, condition and approval of materials on site before the installation by Subcontractors.
Coordinate a team to review and witness successful testing and commissioning/certification of critical systems (i.e., mechanical - HVAC/TABS/DALTS/DDC; electrical - Pad Mounted Transformers/High-Voltage Systems/Switchgear/Automatic Transfer Switches/Frequency Converters, fire and life safety/fire protection systems; roofing systems and underwater structures).
Assure quality workmanship in accordance with specifications and industry standards for concrete/masonry/stucco/building, envelope/structural steel/bolting/welding and other building materials/structural systems, as required.
Attend/witness selected tests and review all applicable test reports and results for completeness and quality.
Maintain extensive contact with key construction contractor representatives to promote an atmosphere of partnering and cooperation, quickly resolving problems while maintaining each construction schedule.
Coordinate temporary utility and communication hook-ups for contractors, plus coordinate utility outages and road closures with Government personnel, as necessary. Coordinate lay-down areas and storage areas, as required.
Coordinate excavation, hot work, burn and other construction-related permits, as required, subject to local restrictions.
In conjunction with the Construction Manager (CM), perform cursory review of Activity Hazard Analyses (AHAs) and ensure via the Site Safety and Health Officer (SSHO) that these are discussed by the construction contractor plus their respective subcontractors prior to beginning each work activity, or when a new work crew is to perform the work in accordance with the three phases of QC.
With the CM, review and provide recommendations toward acceptance of Crane Critical Lift Plans, along with crane operation qualifications and certificate of compliance. Observe critical lifts.
Ensure each construction contractor is conducting monthly site safety self-evaluations and submitting the information with pay vouchers/invoices; perform worksite safety assessments as needed.
Take appropriate, timely action to ensure construction contractor compliance of safety and health requirements, including leading safety stand-downs, as required, and recommending dismissal of key construction contractor staff from the project due to non-performance or recurring violations.
Ensure reporting of contractor significant safety incidents/accidents/near misses, ensuring most importantly that corrective actions have been taken. Perform cursory review/QA of Contractor's Significant Incidence Reports (CSIRs) and OSHA Form 300s (Contractor's Log of Work Related Injuries and Illnesses).
Serve as a point of contact for Supported Command interface/coordination in the field; including supporting collateral equipment installation and phone/data/communication connections; assist with investigation of potential latent defects; and assist with coordination of the installation of cylinders/cores, keying system, and turnover of keys to owner/occupant
Coordinate the facility system training for owner/occupants/PW shop personnel.
Review pre-final contract drawings and specifications (particularly Division 01 administrative requirements) and technical RFPs, respectively. Perform on-site visits to review constructability and compatibility with actual field conditions. During design development and constructability review, provide technical knowledge of local conditions, including availability of construction materials and skilled labor. For any problems found, make solution recommendations for designer consideration.
Qualifications:
5 or more years of verified experience as a Quality Control Manager working for one or more General Contractors (GCs) on NAVFAC or U.S. Army Corps of Engineers (ACOE) projects OR 10 or more years of verified foreman experience in one or more of the following trades: Concrete, Mechanical, Electrical, Masonry or Carpentry on commercial/industrial/military projects. Residential construction experience does not qualify.
Possess, or be able to obtain, a Certificate of Completion for the US Army Corps of Engineers “Construction Quality Management [CQM] for Contractors” course
Possess familiarity with crane safety requirements and the NAVFAC P-307 (Management of Weight Handling equipment) specification
Must be able to successfully pass a drug test and a thorough background check for access onto a military installation; please note the background check for this position extends past 7 years, in conformance with federal law and US Department of Justice guidelines for work on a military installation.
Construction Quality Control Manager
Remote Lead Quality Control Job
Job Title: Construction Quality Control Manager (CQCM)
Overview: The Construction Quality Control Manager (CQCM) is a vital position overseeing quality control activities throughout the project life cycle. The CQCM will be on site from NTP (Construction) through Final Acceptance, ensuring adherence to quality plans and procedures. With a focus on safety, compliance, and quality, the CQCM plays a critical role in achieving project success.
Qualifications:
• Bachelor's degree in construction management, construction science, engineering, or related field (preferred).
• Minimum of 15 years of experience in quality control activities on design-build projects of a comparable size and scope.
• Current OSHA 30, First Aid/CPR, and Construction Quality Control Management certifications, or ability to obtain within 30 days of hire.
Responsibilities:
• Develop and implement project-specific quality control plans.
• Inspect and evaluate work areas, reporting deficiencies and ensuring safe work practices.
• Coordinate with subcontractors to enforce project quality control standards.
• Conduct a three-phase inspection program, including preparatory meetings, initial phase inspections, follow-up inspections, and final phase inspections.
• Lead and document quality control meetings with the project team and/or customers.
• Provide daily quality control reports, addressing non-conformance promptly.
• Verify materials/equipment conformity, handle and store them appropriately.
• Schedule, coordinate, and document code and independent inspections.
• Review as-built drawings and ensure they align with the contract drawings.
• Review and verify the Job Site Safety Plan, conducting safety inspections during the follow-up phase of control.
• Exercise the authority to stop work, reject materials, and direct removal and replacement of non-compliant work.
Minimum Requirements:
• Bachelor's degree in a relevant field (preferred).
• Minimum of 15 years of experience in programs of comparable size and scope.
• Current OSHA 30, First Aid/CPR, and Construction Quality Control Management certifications.
• Exceptional communication skills (written and verbal).
• Proficiency in Microsoft Office (Outlook, Excel, Word, PowerPoint) and Procore.
• Experience in planning, scheduling, and project control functions.
• Knowledge of engineering, procurement, contracts, construction, and startup work processes.
• Experience on major lump sum projects with a direct-hire construction strategy.
• Experience in PANYNJ Projects.
• Proven ability to work independently and efficiently.
• Must pass PANYNJ background check and badging.
• Must be able to commute to EWR Airport.
If you possess these qualifications and are ready for a challenging role ensuring top-notch construction quality, we encourage you to apply. Join a dynamic team shaping the future of construction and infrastructure!
JGM offers a comprehensive benefits package designed to support employee well-being and financial security.
Our benefits include:
Medical, Dental, and Vision Insurance
Comprehensive health coverage to ensure employees and their families receive quality healthcare protection.
401(k) Retirement Plan
Competitive retirement savings program with up to 4% company matching, helping employees build long-term financial stability.
Flexible Work Schedule
Empowering employees with the ability to balance work and personal life through adaptable working hours and potential remote work options.
Additional Insurance Benefits
Life insurance to provide financial protection for employees' loved ones
Pet insurance to support employees' furry family members
Paid Time Off
Flexible time off to promote work-life balance and employee wellness
Quality Assurance Specialist
Lead Quality Control Job In Washington, DC
We are currently seeking a motivated, career and customer-oriented QA Tester to join our team in Washington DC to begin an exciting and challenging career 6-month contract to hire opportunity.
In this role you will support/develop JAVA based applications along with .NET and MQ messaging. The ideal candidate should be proficient in understanding the Software Development Lifecycle and the supporting software necessary to perform change management. The candidate will be testing various scenarios within the various applications and documenting results. The candidate will work closely with other teams within AFMS to facilitate the Program's SDLC.
Required Qualifications/ Duties/Tasks and Responsibilities
Specific duties include, but are not limited to:
Bachelor's Degree, Minimum Required Years of Experience =5
US Citizenship is required
Must pass a Minimal Background Investigation, MBI, Level 5 background investigation. Valid EQIP JPAS transfers acceptable
Plans and develops functional test plans and for all phases of testing
Design, execute, and maintain automated and manual test scripts
Generating test data
Data Validation, execute regression, functional, load and system testing
Verifying results and producing test summaries and defect reports
Identifying defects and requirement discrepancies
Generating defect change requests and reporting discrepancies
Technical Proficiencies
Ability to develop automated scripts using advanced techniques. Ability to review test requirements, create automated scripts, and organize into test execution suites using Rational automated test tools, Rational Test Manager, Rational Functional Tester a plus
Must have capability to develop SQL to support testing analysis activities, including back end database testing.
Proficient with Microsoft Office (Word, Excel, etc.)
Hands on experience with Soap UI, TOAD, and Data Studio is preferred
Senior QA QC and Commissioning Specialist
Remote Lead Quality Control Job
Senior QA QC & Commissioning Engineer
DataX Connect are partnered with a global real estate company who are dedicated to making an impactful difference to the data center/ mission critical sector.
Due to outstanding growth and further investments to the business, they are looking to hire an experienced of Senior QA/QC or Electrical Commissioning Engineer to take lead on multiple large data center projects.
The position
The position entails working with a diverse group of internal and external Stakeholders at all levels of the organization, and the individual will require the independent judgement to plan, prioritize, and organize a diverse workload in a fast-paced environment. This successful candidate will be detail oriented with strong organizational skills, and a team player attitude.
Responsibilities
Have fluency with all commissioning processes and deliverables covered in ASHRAE, CSA, and LEED commissioning requirements.
Expertise in electrical equipment/systems installation (means & methods), system startup and pre-functional inspections, acceptance testing and associated commissioning activities.
Work directly with General Contractors, trades, inspectors, AHJs, and others involved with the QA/QC program execution for large critical facility construction and commissioning.
Monitor, review, and execute all facets of Commissioning related projects by providing exceptional technical and field activities.
Perform Commissioning Design Drawing & Specification Reviews, as well as Submittal (shop drawing) reviews.
Qualifications and previous experience
A recognized university degree or equivalent, or at least 5 years of significant and applicable knowledge and experience in data center QA/QC. Engineering Degree is preferred.
A minimum of 7 years of relevant electrical engineering and/or field-testing experience with minimum of 5 years in providing building commissioning and/or construction QA/QC field services for data centers
Why Apply
Join a fantastic group of experienced data center professionals.
Continuous growth throughout the business.
Competitive salary, benefits and bonus.
Benefits
401(k) plan with matching company contributions
Comprehensive Medical, Dental & Vision Care
Paid parental leave at 100% of salary
Paid Time Off and Company Holidays
Flexible and Remote Work Arrangements may be available
Air Quality Project Manager
Remote Lead Quality Control Job
Flatrock Engineering and Environmental, LLC (Flatrock) is a full-service oil & gas consulting firm, which has been supporting client engineering and regulatory compliance needs since 1999. We provide a wide range of engineering, environmental, compliance, and health & safety services that are customized to satisfy our clients overall regulatory compliance objectives. Refer to our website for additional information: Home - Flatrock Engineering & Environmental, LLC (flatrockenergy.net)
Position Summary
Flatrock is growing and looking for an experienced air quality environmental professional to join our Team in San Antonio, TX (option for remote work). Qualified candidate must have experience with Texas air quality permitting and compliance regulations applicable to oil and gas facilities. Additionally, air quality permitting, and compliance experience is preferred for oil and gas facilities that operate in Oklahoma, New Mexico, Wyoming, Louisiana, and/or Colorado. Position will coordinate air permitting tasks for new/existing sources and facilitate regulatory compliance efforts, including state/federal reporting requirements.
The selected candidate will proactively collaborate with clients to develop effective compliance solutions, while maintaining operational flexibility. Effective communication, time management, organizational, and detailed oriented skills are critical for this role. The selected candidate will collaborate with and maintain strong working relations with the clients that we support.
Flatrock provides a competitive salary commensurate with experience. We also offer medical, dental and vision benefits, retirement plans (401K matching), and paid time off.
Responsibilities
• Maintain strong working knowledge of state/federal air quality regulations applicable to oil and gas facilities operating in Texas, Oklahoma, Louisiana, and New Mexico.
• Develop and submit air quality construction/operating permit applications, including data gathering & validation, emission calculations, regulatory applicability analyses, and completion of applicable regulatory forms.
• Develop compliance solutions that align with permit requirements and support any regulatory reporting applicable to our clients.
• Collaborate with regulatory agency representatives to resolve any questions and data requests associated with permit applications and compliance issues.
• Evaluate complex regulatory requirements and develop compliance solutions that meet or exceed our clients' regulatory objectives.
• Proactive client communication and collaboration.
• Maintain positive working relationships with state/federal regulatory personnel.
• Detailed oriented to ensure a high level of data accuracy.
Minimum Requirements
• Three (3) years experience with state/federal air quality permitting and compliance requirements applicable to the oil and gas industry AND
• Bachelors degree in a related field OR
• Five (5) years experience with state/federal air quality permitting and compliance requirements applicable to the oil and gas industry.
• General knowledge of upstream, midstream, and downstream oil & gas facilities and operations.
• Thorough knowledge of state/federal air quality regulations applicable to oil and gas facilities operating in Texas.
• Experience with performing complex emission calculations for oil and gas point sources.
• Strong technical writing skills.
• Effective communication, time management, and organizational skills to ensure successful coordination and implementation of multiple projects.
• Ability to manage multiple projects/tasks while satisfying client deadlines.
• Candidate must be self-motivated and possess a strong work ethic.
If you are interested in applying, please send your resume to ***************************
Software Quality Assurance Specialist
Lead Quality Control Job In Merrifield, VA
MBA CSi is seeking an experienced and detail-oriented Software Quality Assurance Specialist to join our Software Process Management (SPM) Team, supporting the Engineering Systems (ES) division of the U.S. Postal Service in Merrifield, VA. The SPM Team maintains the ES software development life cycle (SDLC) process on new mail process equipment (MPE), mail handling equipment (MHE), support systems (SS), and maintenance releases on existing equipment. Within the SDLC process, SPM performs configuration management, independent verification and validation, as well as software and system test activities tasks to support and participate in the release process. The USPS ES organization designs and develops MPE/MHE, including integration of the respective support systems/subsystems for the equipment. The automation processing equipment consists of a combination of hardware, controls systems (operational technology, OT), software applications, databases, and Web applications in a combination of distributed and centralized environments.
The current SDLC includes legacy Waterfall and hybrid Waterfall-Agile processes, with most development teams still using the Waterfall process. SPM's hybrid-Agile process includes VersionOne and ALM Enterprise applications and customized hybrid-Agile process steps in the SBM application. The SDLC tools in place for the SDLC process are customized using MicroFocus Serena Business Management (SBM) and Dimensions applications, and the ES Web site (reports and training documents). The SPM Team supports and manages these systems.
The Software Quality Assurance Specialist focuses on ensuring quality assurance, regulatory compliance, and effective management of technical records and archives. The ideal candidate will have a strong background in records management, excellent organizational skills, and familiarity with document control processes in a technical or engineering environment.
This is an exciting opportunity to contribute to mission-critical software systems within the U.S. Postal Service. If you have a passion for software quality and process improvement, we'd love to hear from you!
Responsibilities
Collect, scan, index, and archive technical records, ensuring completeness and accuracy
Maintain and manage the archive function within the Engineering department
Ensure compliance with quality assurance standards and regulatory requirements for technical files and records
Generate and maintain technical audit reports using Microsoft Office for external auditing purposes
Develop and maintain procedures and processes related to records and document management
Ensure technical data is accurately recorded, classified, and easily retrievable
Collaborate with team members, customers, and external stakeholders to provide technical records and archive support
Utilize electronic document management systems to upload, version, and maintain technical records and archives
Basic Qualifications
Bachelor's Degree in Engineering (preferred) or related field
Degree program must be accredited by a U.S. board of accreditation such as ABET
5+ years of experience in records and archive management, preferrable in a technical or engineering environment
Experience with SDLC processes (Waterfall, Agile, and hybrid approaches)
Familiarity with document control and compliance in a technical or engineering context
Familiarity with regulatory compliance standards in technical fields
Experience with electronic document management systems and version control
Proficiency in writing technical audit reports using Microsoft Office
Excellent attention to detail with a strong focus on accuracy
Strong organizational skills and the ability to manage multiple projects and prioritize tasks effectively
Ability to work collaboratively in team environments and with customers
Strong written and verbal communication skills
A proactive approach to problem-solving and process improvement
Ability to obtain and maintain a Public Trust security clearance
Must be able to pass a pre-employment background check & drug test
MBA Consulting Services, Inc. (MBA) is a federal government IT systems integrator committed to delivering solutions that solve mission challenges with agility, experience, and innovation. As a mission-focused integrator, we provide a comprehensive range of information technology, engineering, professional services, and facilities management solutions. We have proven expertise in delivering custom data analytics, digital services, systems engineering, human factor engineering, and infrastructure solutions.
MBA is headquartered in Chantilly, Virginia, has more than 400 employees, and is in 46 locations nationwide. With proven leadership and a 25-year heritage, our reputation has been forged by acquiring and developing the best talent in a values-driven culture of integrity, respect, and quality solutions.
"MBA CSi is an Equal Opportunity, Affirmative Action Employer. Women, Minorities, Veterans, and individuals with disabilities are encouraged to apply.”
EOE - Minority/ Female/ Veteran/ Disabled
Quality Control Manager
Lead Quality Control Job In Manassas, VA
Helix Electric was founded in 1985 and is now one of the nation's largest and most successful electrical contracting companies. Our commitment to empowering people and powering projects is realized by our exceptional team of dedicated and highly skilled experts working together and never settling for good enough. We are proud of the team-oriented and employee-empowered business approach that defines our unique character.
The electrical Quality Control Manager is responsible for working closely with the Project Manager and Superintendent to support the department with QAQC and final commissioning implementation and execution.
DUTIES & SCOPE:
Work closely with project management team to coordinate all required testing and inspection reports as required by the project requirements.
Work closely with project engineering team to help facilitate submissions of testing and inspection reports as required.
Development and execution of project required QC Plan
Assist with the coordination efforts related to formal notifications as required.
Lead all vital QC documentation - Reports, Test Data, Logs, QC Daily Reports etc.
Cross-reference and back-check all required testing standards for compliance.
Work closely and coordinate with 3rdparty testing firms as needed.
Regular site walks on the project site to support and verify QC activities.
Workwith the Superintendents and Field personnel to promote adherence to QC standards when needed.
Ensure quality control procedures and safety guidelines are adhered to.
Work proactively and productively with the project team to assess and correct any potential deficiency items.
Work collectively with the commissioning team.
Provide top service to our clients with consistent and concise communication.
QUALIFICATIONS:
Minimum of 5 years in the electrical construction field
Minimum of 2years of management experience in construction environment performing QA/QC auditing
Experience with electrical equipment and conductors to ensure safe testing, QC, and commissioning.
Experience with safe start-up of electrical systems
Experience with de-energizing, Lockout tag of electrical systems
Working knowledge of NFPA 70 (NEC) and 70E (Electrical Safety in the Workplace)
Excellent knowledge of data acquisition systems (monitoring, communications, networking)
Up to date and current computer knowledge, including Excel, MS Office, email, internet, DAS software, interface systems, Bluebeam.
Strong communication and interpersonal skills, teamwork attitude
Clean DMV, drug test results, and background check
Helix Electric provides a comprehensive benefits package that includes the following:
Medical Plans
Dental Plans
Vision Plan
Life Insurance
Disability Insurance
Accident Insurance
Critical Illness Insurance
Hospital Insurance
Pet insurance
401(k) Plan with Match
Employee Discount Program through PerkSpot
Tax Savings Accounts - FSA, HSA, DCFSA and CSA
Tuition Reimbursement
Scholarships
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
RequiredPreferredJob Industries
Other
Bilingual Quality Assurance Specialist *HYBRID* AZ
Remote Lead Quality Control Job
Ready to join a team that values quality, accuracy, and exceptional customer experiences? We're seeking a passionate and detail-oriented Quality Specialist to support a Quality Assurance Team in delivering top-tier service to customers. In this role, you'll play a vital part in ensuring the quality and accuracy of work completed by call center and external business partner team members. If you're looking for a role where you can apply your analytical skills, work collaboratively, and make an impact, we'd love to hear from you!
Job ID: 148961
Worksite: Chandler, AZ **Expected to work on-site a few days per month
Hours: Monday through Friday, 8 hour shift between 7 AM and 5 PM
Availability for occasional overtime during evenings, weekends, and holidays is required
Pay: $18.05/hr.
What You'll Be Doing
Evaluate and verify the quality and accuracy of telephone and clerical work performed by call center staff and business partners
Attend calibration sessions to ensure consistency in processes, procedures, and scoring
Leverage recording and monitoring applications to compile data and generate reports that align with business objectives
Work collaboratively with team members to meet performance expectations and maintain high-quality standards
Successful candidates will possess:
Bilingual in Spanish
2+ years of experience working in a call center environment
Strong written communication, attention to detail, and organizational skills
Proficiency in Microsoft Office applications (Word, Excel, etc.)
Critical thinking skills and the ability to work effectively in ambiguous situations
A strong sense of accountability and the ability to maintain regular, predictable attendance
Capability to work flexible hours, including occasional evenings, weekends, and holidays
A functional high-speed internet connection to facilitate working from home as needed
Preferred: Automotive finance experience
To Apply for this Job: Click the Apply Online button, then:
If you are currently registered with CornerStone Staffing, click the Log In button to add yourself as a candidate to this job - NOTIFY YOUR RECRUITER OF INTEREST IN JOB ORDER: 148961.
If you are NOT currently registered with CornerStone Staffing, click the Create Account button to complete the application
#ZIP
#CB
Lending Quality Assurance Manager
Remote Lead Quality Control Job
Figure is maximizing the value of homeownership in ways that benefit consumers and the industry alike. We're helping homeowners tap their liquidity easily, efficiently and reasonably for purpose-driven, significant expenditures - everything from dream home renovations and debt consolidation to small business formation.
In seven years, we've become the country's #1 non-bank HELOC lender. As a financial technology firm operating at the intersection of regulation and transformation, we're a “unicorn” - a group of fewer than 1000 companies globally that is valued at $1B or more and has been in operation for less than ten years.
Our mission requires us to have a creative, team-oriented, and supportive environment where everyone can do their absolute best. We are motivated, innovative, collaborative, and curious. We value individuals who bring a problem-solving mindset to every task. Every day at Figure is a journey in continuous learning combined with a focus on getting work done that makes a difference. Join us!
Wealthfront Career-Launching Company
Figure Series D Announcement
About the Role
We're looking for a high-performing, analytical, data-driven Quality Assurance (QA) Manager to join our growing team! In this role, you will partner cross-functionally and help lead the pre-closing QA function in delivering a best-in-class product and customer experience.
What You'll Do
Develop and maintain a strong Quality Assurance program.
Perform Quality Assurance reviews on Figure's lending products such as HELOCs and mortgages.
Assist with monthly QAC reporting, data analysis, and defect trending within QA/QC software and tools
Collaborate with Lending Operations, Product, and Data to improve loan production quality and risk detection
Partner with the Compliance and Capital Markets teams to ensure processes, procedures, and loan products meet investor eligibility requirements
Recommend underwriting and change-management enhancements based on QA audit results and industry/investor product changes
Underwrite Figure loan files for income calculations, assets, red flags, credit, and collateral.
Review file data integrity and identify defects in the loan production process
Perform credit analysis, ensuring all loans meet agency and investor eligibility
Review pre-closing loan documents to ensure compliance with all Federal, State, and local compliance requirements and regulations
Work closely with Lending Operations on trending defects and remediation
Recommend and implement enhanced quality assurance methodologies and metrics to improve overall quality
What We Look For
5+ years of regulatory underwriting, compliance, quality assurance, lending operations, or related experience
Bachelor's Degree
Ability to handle several projects at once while staying organized, detail oriented, and diligent
Ability to work effectively across functions to achieve common goals
Strong communication skills - ability to articulate verbally and in writing, plans, processes, policies, and issues to stakeholders
Ability to thrive in a fast-paced startup environment
Experience navigating and applying Fannie Mae conforming, and investor and aggregator and non-conforming, underwriting guidelines
Competency in, and understanding of investor, rating agency and third-party review requirements
Knowledge regarding federal and multi-state regulations impacting the mortgage industry a plus
Strong analytical skills and attention to detail and time management
Ability to handle multiple assignments in a high production, timeline sensitive environment with minimal supervision
Excellent verbal and written communication
Proficient in Microsoft office products especially Excel as well as QA testing software
Salary
Compensation Range:
$109,120 - $136,400
Quarterly 25% bonus target
Equity stock options package
This is the compensation range for the United States, actual compensation may vary based on individual candidate experience, location, or evolving business needs
Benefits
Comprehensive health, vision, and dental insurance with 100% employer-paid premiums for employees and their dependents on select plans
Company HSA, FSA, Dependent Care, 401k, and commuter benefits
Employer-funded life and disability insurance coverage
11 Observed Holidays & Accrued PTO plan
Up to 12 weeks paid family leave
Continuing education reimbursement
Depending on your residential location certain laws might regulate the way Figure manages applicant data. California Residents, please review our California Employee and Prospective Employee Privacy Notice for further information. By submitting your application, you are agreeing and acknowledging that you have read and understand the above notice.
Figure will not sponsor work visas for this position. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.
#LI-RF1 #LI-Remote
Quality Control Manager (QCM)
Remote Lead Quality Control Job
At APTIM, we come to work each day knowing that we are making an impact on the world. Our work spans from safeguarding and maintaining critical infrastructure to helping communities recover from natural disasters, from empowering our armed forces and first responders to reducing carbon and energy use, and from making cities more resilient against the threats of climate change to restoring contaminated ecological systems.
Job Overview:
The Quality Control Manager (QCM) is responsible for the quality of decommissioning work.
The QCM will be responsible for assuring the project team implements the policies and procedures required under contract and assuring corrective action is taken if performance does not meet internal or quality requirements.
What you can expect from APTIM:
Work that is worthy of your time and talent
Respect and flexibility to live a full life at work and at home
Dogged determination to deliver for our clients and communities
A voice in making our company better
Investment into your personal and professional development
Key Responsibilities/Accountabilities:
Managing Project Quality Control Plan implementation by the project team
Involving the engineering team in development of field QC inspection plans and checklists for environmental and civil work performed by subcontractors
Reviewing, approving and tracking QC submittals
Conducting weekly project meetings with staff, subcontractors and customer representatives
Writing clear and concise reports
Implementing a tracking system for issues and actions regarding such things as nonconforming materials, tests and field work
Will work closely with the PM to ensure established protocols and procedures are implemented, and the work performed is in accordance with the contract
Responsible for directing, planning, implementing, and tracking quality control (QC) activities and maintaining internal communication on QC matters
Responsible for QC staffing and ensuring QC data evaluation, data verification, and reporting procedures are followed
Basic Qualifications:
B.S. in Engineering, Physical Science or Construction Technology/Management is preferred.
Must have at least 10 years, or equivalent, experience in QC or a similar field and 5 years of experience on radiological decommissioning or remediation projects.
Confined-Space trained and capable, or ability to obtain
Familiarity with inspection programs
Knowledge of and familiarity with industry HSE requirements
Knowledgeable regarding relevant industrial codes, standards and specifications (i.e. ASME, API, ASTM, AWS, AWWA, AISC, ACI, IEEE ...etc.)
Strong written and verbal communication skills
Working knowledge of Microsoft suite
Experienced with client and client representative interaction
#LI-BM1
Additional Job Information
Who we are and what we do:
APTIM is a global industry leader headquartered in Baton Rouge, Louisiana. With more than 4,000 employees worldwide, APTIM specializes in critical infrastructure, technical and data solutions, program management, environmental services, resilience, as well as sustainability and energy solutions. Our dedicated people have the proven experience and expertise to provide integrated services and solutions to government agencies, commercial, industrial, and energy customers. APTIM is committed to accelerating the transition toward a clean and efficient energy economy, building a sustainable future for our communities and the natural world, and creating an inclusive equitable environment that celebrates the diversity of our people.
Watch our video:
Aptim Making a Difference
Alternate Locations
Employment Type
Full Time
Remote Work Eligible
Yes
Our Motto
APTIM is a place where our people make a difference, not just a living.
Construction Quality Control Manager
Lead Quality Control Job In Indian Head, MD
It's fun to work in a company where people truly BELIEVE in what they're doing!
We're committed to bringing passion and customer focus to the business.
The Construction Quality Control Manager position is a critical role throughout the entire project. This role will be responsible for implementation of the Quality Control Plan and assurance to the Quality Control System and applicable standards (ISO and Department of Defense) on multiple construction projects. This position is 100% on-site in the Indian Head, MD area.
Chickasaw Nation Industries, Inc. serves as a holding company with multiple subsidiaries engaged in several lines of business (Technology, Infrastructure & Engineering, Health, Manufacturing, Public Safety, Consulting, and Transportation) for the federal government and commercial enterprises. A portion of our profits is used to support Chickasaw citizens. We are proud to support the economic development and long-term viability of the Chickasaw Nation and its people. CNI offers premium benefits eligible on the first day of hire to full time employees; (Medical - Dental - Vision), Company Life Insurance, Short-Term and Long-Term Disability Insurance, 401(K) Immediate Vesting, Professional Development Assistance, Legal Aid Assistance Program, Family Planning / Fertility Assistance, Personal Time Off, and Observance of Federal Holidays.
As a federal contractor, CNI is a drug-free workplace and adheres to the Federal Controlled Substance Act.
ESSENTIAL REQUIREMENTS
Must be able to obtain and maintain the required customer clearance for access to systems, facilities, equipment and property.
Construction Quality Manager Certification required.
High School Diploma or General Education Degree (GED) and a minimum of five (5) years' related experience in Construction Quality Management, or equivalent combination of education / experience.
KEY DUTIES AND RESPONSIBILITIES
Essential Duties and responsibilities include the following. Other duties may be assigned.
Knowledge of health and safety regulations, practices and procedures.
Detail-oriented with exceptional organization, analytical, problem-solving and critical thinking skills.
Excellent verbal and written communications skills with solid presentation and reporting skills.
Excellent customer service skills.
Ability to clearly and concisely communicate / explain information to a broad range of people with varying levels of expertise and/or responsibility.
Ability to determine and document appropriate guidelines for all quality assurance measurements.
Ability to construct, document and implement approved procedural changes.
Ability to manage multiple projects and priorities as well as to meet specified deadlines.
Ability to use discretion in the handling of confidential or sensitive information.
Ability to work both independently and in a team environment.
EDUCATION AND EXPERIENCE
High School Diploma or General Education Degree (GED) and a minimum of five (5) years' related experience in Construction Quality Management, or equivalent combination of education / experience.
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this job.
The physical demands described here are representative of those that must be met by an employee to perform successfully the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this job. Work is primarily performed in an office environment. Regularly required to sit. Regularly required use hands to finger, handle, or feel, reach with hands and arms to handle objects and operate tools, computer, and/or controls. Required to speak and hear. Occasionally required to stand, walk and stoop, kneel, crouch, or crawl. Must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, depth perception, and ability to adjust focus. Exposed to general office noise with computers printers and light traffic. Work is primarily performed in a factory, machine shop or construction environment. The ability to verbally communicate alarms or warnings clearly, concisely, loudly and quickly, to clearly and quickly hear or otherwise sense alarms or warnings and take appropriate action. The ability to see and distinguish colors, to visually distinguish shapes and patterns, to accurately sense distances (depth perception), to accurately see objects and detect motion at wide angles (peripheral vision). May have exposure to indoor/outdoor adverse weather conditions. Frequent exposure to noise - workers must wear protective hearing equipment or frequently shout in order to be heard above the ambient noise level. Exposure to pollutants or allergens which can adversely affect the skin and/or the respiratory system such as gases, smoke, odors, mists, fumes, dust, chemicals, oils or solvents. Exposure to hazardous working conditions including moving machinery, electricity and/or working in high places. May be exposed to hot objects, flames or sparks. The job requires the use of protective equipment such as hard hats, respirators, aprons, gloves, special clothing, safety shoes and safety glasses.
EOE including Disability/Vet
*Please note, that this position is contingent upon the award or funding. The essential duties, experience, education requirements, and salary are subject to change.
*
The estimated pay range for this role is $110K to $120K, with the final offer contingent on location, skillset, and experience.
CNI offers a comprehensive benefits package that includes:
Medical
Dental
Vision
401(k)
Family Planning/Fertility Assistance
STD/LTD/Basic Life/AD&D
Legal-Aid Program
Employee Assistance Program (EAP)
Paid Time Off (PTO) - (11) Federal Holidays
Training and Development Opportunities
Your application submission will be considered for all potential employment opportunities with Chickasaw Nation Industries (CNI).
If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!
Senior Quality Control Manager (USPTO Experience)
Lead Quality Control Job In Alexandria, VA
We are seeking an experienced and detail-oriented Senior Quality Control Manager with a deep understanding of USPTO (United States Patent and Trademark Office) guidelines and procedures. The successful candidate will lead our quality control team, ensuring compliance with industry standards, internal quality benchmarks, and USPTO regulations. You will be responsible for developing, implementing, and overseeing quality control processes to enhance the integrity of our patent submissions, intellectual property documentation, and related legal processes. This position is remote 2-3 days per week.Responsibilities:
Lead and manage the quality control department, including supervising staff and providing training to ensure adherence to USPTO and internal standards.
Oversee quality control processes for patent submissions, ensuring all documents are compliant with USPTO guidelines and free from errors.
Develop and implement quality control strategies, policies, and procedures to improve accuracy, efficiency, and compliance.
Conduct thorough reviews of patent applications, amendments, and other intellectual property-related documents.
Collaborate with patent attorneys, agents, and other departments to resolve any issues or discrepancies in submissions.
Monitor and report on key quality metrics, identify trends, and implement corrective actions as necessary.
Ensure that all quality control documentation and processes are up-to-date and compliant with relevant legal and industry standards.
Stay informed on changes in USPTO policies, guidelines, and best practices, and communicate these updates to the team.
Lead continuous improvement initiatives, driving process improvements in quality assurance systems.
Coordinate audits, both internal and external, to maintain and improve quality compliance.
$80,000 - $105,000 a year
Senior Scientist, Quality Control
Remote Lead Quality Control Job
Turnstone Biologics (“Turnstone”), a public clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone's proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1 trial in solid tumors for the lead TIL therapy candidate, TIDAL-01, and a Phase 1 trial in partnership with the Moffitt Cancer Center.
At Turnstone, the science drives decision-making and our therapeutics are designed with the patient foremost in mind. We continue to build a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal - actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding thereafter are what we call ‘another day at Turnstone'? If you are a passionate person, and our science excites you - this opportunity may be for you.
POSITION OVERVIEW
We are seeking an innovative, self-motivated and versatile individual to join us as a Senior Scientist, QC within the Quality organization. This is a key role focused on method qualification/validation, method life-cycle management, technical support of external manufacturing partners, including supporting method transfer, method optimization, technical document authoring, IND support impact assessment, laboratory investigation, data trending and method trending/monitoring. The candidate will work closely with Analytical Development, Process Development, Quality Assurance, Translational Science and Regulatory team members. This role is critical in developing a strong partnership with our CDMOs in pursuit of advancing our pipeline and is expected to be hands-on in the technical and operational details of the Manufacturing and Quality Control operation at CDMOs.
KEY RESPONSIBLITIES
Contribute to and implement QC method qualification and validation strategy in collaboration with Analytical Development. Accountable and responsible for implementing the detailed method qualification and validation strategy with key stakeholders.
Technical review and approval of method qualification/validation protocols and reports, transfer protocols and reports, and stability reports.
Technical review and approval of executed test methods at the CDMO and ensure they meet the requirements of Turnstone's process and regulatory guidelines.
Support timely and accurate documentation in support of the various Quality records (laboratory investigation, deviations, impact assessments, CAPAs, change controls).
Provide hands-on technical support to laboratory investigation, deviations, non-conformance events, and ensure batch disposition decisions are guided by sound technical rationale.
Collaborate in cross-functional teams to support, execute and/or provide oversight in the execution of method optimization, extended characterization, troubleshooting, transfer, and qualification/validation.
Develop, revise, review, approve, and own SOPs (Standard Operating Procedures) and technical (transfer, validation, bridging, etc.) protocols/reports.
Assist in reviewing data and assist with product and assay control trending and monitoring.
Cultivate a team culture of high standards, collaboration, empowerment, and trust.
Additional duties as assigned.
PROFESSIONAL EXPERIENCE AND QUALIFICATIONS
Bachelor's or Master's degree with demonstrated experience in cell therapy, immunology, cancer biology or a closely related field, and 7+ years of industry experience, preferably in gene and cell therapy.
Expeience with different phases of drug development
Experience with relevant technologies on flow cytometry, ELISA/ELLA, cell counter, qPCR, dd PCR methods, endotoxin, sterility testing (e.g. BacT/alert).
Experience and successful track record of method transfer/verification/qualification/validation, routine testing in QC environment.
Knowledge related to scientific data analysis applications such as GraphPad Prism, FlowJo, FACSDiva, Novocyte, Spotfire, and JMP software packages.
Excellent technical writing experience in a regulatory environment (such as protocols, reports, and SOPs).
Implementation of "best practices" or leading-edge quality standards.
Project Management skills, including the ability to manage project resource requirements (material, manpower, time, etc.), and ability to elevate relevant issues to project lead and line-management.
Experience in IND, NDA and BLA submission is highly preferred.
Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.
Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.
Highly effective organization, written, and verbal communication skills to address a wide variety of audiences and governing bodies.
Demonstrated resilience, diplomacy, influence, relationship-building, and problem-solving skills in various situations.
Leads by example to foster Turnstone Biologics culture.
Occasional travel to support cross-functional workshops or strategy/planning activities
COMPENSATION AND BENEFITS
At Turnstone, we prioritize the well-being and success of our team. Join us and enjoy a competitive compensation package, including a base salary and performance-based bonuses. Our comprehensive benefits include:
Healthcare Coverage: Medical, dental, and vision insurance for you and your dependents.
Retirement Planning: 401(k) plan with employer contributions.
Time Off: Generous paid time off, including vacation, sick leave, and holidays.
Workplace Flexibility: Flexible schedules and remote work options.
Turnstone Biologics welcomes and encourages applications from people with disabilities. Accommodation is available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.
Quality Control Manager
Lead Quality Control Job In Lorton, VA
As a Quality Control Manager, you will ensure the project is built within contract document specifications, owner requirements, and comply with local, state, and federal building codes. You will coordinate with other trades, process daily reports of project progress and adhere to all guidelines issued by the owner. As a strong communicator, you will help to build a quality control team that is open, transparent, and delivers excellence.
Responsibilities
Partner with the project team to understand, plan, and implement the contract drawings and specifications
Collaborate with the owner, design team, and contractors to ensure quality and timeliness of project construction and completion
Implement and manage the “Three Phases of Control” Quality Control Plan
Oversee submittal review and approval
Schedule and conduct quality control meetings - Preparatory, Initial Phase, Follow-up
Control documents related to quality control functions
Establish testing procedures in accordance with contract specifications
Manage inspections process
Coordinate third party testing agents and interface with the Owner's representatives as required
Closely track and maintain a project deficiency log
Manage the punch list process
Oversee project closeout deliverable process-training, O&Ms
Confer directly with the executive management team
Encourage, lead, and/or participate in staff training and development
Proactively identify and develop relationships with industry professionals to generate and win the right work
Take an active role in recruiting top industry talent to join the Clark team. Identify, hire, and retain outstanding people
Exceed our stakeholders' expectations by anticipating their needs, desires, and goals
Basic Qualifications
Undergraduate degree in a construction or related discipline or relevant experience
Minimum 5-8+ years verifiable construction quality control and/or inspection experience
Takes initiative and personal responsibility to always deliver value and excellence
Uses expertise to create a vision and aligns the team to deliver/achieve desired outcomes
A track record of establishing/contributing to creative strategic solutions
Ability to communicate effectively with, persuade, and gain “buy-in” from, a broad range of stakeholders (e.g., executive team, leadership team, Business Unit Leaders, direct reports, clients, trade partners, and third party providers
Alignment to Clark Standards of Excellence: self-motivated, results oriented, adaptable, team player, accountable, ethical, innovative, resilient, builds relationships, builds people/teams and followership, sets direction and executes
Preferred Qualifications
Experience in large scale construction management or construction trade with increasing levels of responsibility
Must be able to manage other inspectors and submittal clerks, as well as coordinate independent material testing and lab work
Ability to process a large volume of submittals / RFIs
Prior experience developing and managing Quality Control Plans
#LI-LP1