Senior Quality Assurance Manager

2 weeks ago

Lompoc, California, United States DenMat Holdings, LLC Full time
Job Overview

Position Summary

In this pivotal role, you will be responsible for formulating and executing departmental objectives and strategies to align with the overall goals of the organization.

Key Responsibilities include but are not limited to:

  1. Oversee and synchronize the efforts of Quality Control and Quality Assurance to ensure alignment with organizational goals and resolve issues effectively.
  2. Play a crucial role in ensuring compliance with cGMP, ISO13485, 21 CFR 211 and 820, and other relevant regulations concerning the production, marketing, and distribution of pharmaceuticals, medical devices, and cosmetics.
  3. Manage quality control procedures through subordinate supervisors, ensuring adherence to product specifications and quality standards.
  4. Supervise Quality Engineering tasks related to the design, execution, and enhancement of complex manufacturing processes to elevate quality and efficiency.
  5. Conduct Management Reviews and Annual Product Reviews in accordance with the company's Quality Management System requirements.
  6. Identify and propose technical enhancements and projects for management consideration.
  7. Assist in the creation of specifications and drawings for existing products, raw materials, and components.
  8. Support the qualification process for new or modified raw materials, components, and critical suppliers.
  9. Act as the designated Management Representative for the organization, representing the company in discussions with regulatory bodies.
  10. Stay informed on changes in standards across key markets, including the U.S., E.U., Canada, and others.
  11. Support Lean, 5S, and Six Sigma initiatives related to manufacturing.
  12. Facilitate the transition of new product processes from R&D to manufacturing, including prototype development and testing.
  13. Ensure that all drug products are accompanied by appropriate development history documentation and that Master Production Records and Batch Production Records are meticulously maintained.
  14. Provide direction to vendors and suppliers regarding the procurement of necessary equipment and materials.
  15. Oversee technical support for regulatory submissions, including US 510(k) and EU Technical File documentation.
  16. Lead root cause analysis for product failures within Quality Assurance.
  17. Manage projects, including planning, budgeting, scheduling, and tracking to ensure timely and cost-effective completion.
  18. Delegate tasks to technical staff and monitor project performance, coordinating activities across departments.
  19. Evaluate and enhance current procedures to achieve departmental objectives.
  20. Analyze departmental costs and implement cost-saving measures.
  21. Initiate personnel actions, including hiring, promotions, and disciplinary measures as necessary.
  22. Conduct employee evaluations and recommend training based on assessed needs.
  23. Maintain a high standard of professionalism and work ethics.
  24. Represent the organization positively in all interactions.

Additional Responsibilities may include:

  1. Providing technical support to Sales, Customer Service, and other departments as needed.
  2. Traveling for business purposes as required.
  3. Performing other assigned tasks.

Supervisory Duties

Will carry out supervisory responsibilities in accordance with organizational policies and applicable laws, including hiring, training, and performance management.

Qualifications

A Bachelor's degree in Engineering or a related field, along with 5-8 years of operational, manufacturing, or quality assurance experience in drug manufacturing is required. A minimum of five years in the drug manufacturing sector is essential, or an equivalent combination of education and experience.

Skills and Abilities

To excel in this role, candidates must possess:

  • Strong analytical and interpretative skills for business and technical documentation.
  • Proficiency in mathematical principles, including calculus and advanced statistics.
  • Competence in using word processing, spreadsheet, and database applications.
  • Knowledge of international drug and device regulations.
  • Leadership capabilities and the ability to function as a technical expert.
  • Excellent communication skills for presenting information effectively.
  • Ability to manage multiple projects and prioritize tasks efficiently.

Physical Requirements

Employees must be able to perform essential functions in a controlled environment, which may include sitting, standing, and lifting up to 25 pounds. Protective equipment may be required in certain situations.

Compensation and Benefits

The organization offers a comprehensive benefits package, including medical, dental, vision, life insurance, 401(k) with matching contributions, paid time off, and employee discounts.

Equal Opportunity Employment

DenMat Holdings, LLC is an Equal Opportunity/Affirmative Action Employer, ensuring that employment decisions are based on merit and qualifications without discrimination.

  • Senior Quality Manager

    1 week ago

    Lompoc, California, United States DenMat Holdings, LLC Full time

    Job OverviewPosition SummaryIn this role, you will be responsible for establishing and executing departmental goals and strategies to align with the overarching objectives of the organization.Key Responsibilities include, but are not limited to:Oversee and manage the functions of Quality Control and Quality Assurance to meet company targets and resolve...

  • Rocket Quality Assurance Specialist

    2 days ago

    Lompoc, California, United States SpaceX Full time

    Job SummaryWe are seeking a highly skilled Rocket Quality Assurance Specialist to join our team at SpaceX. As a key member of our quality assurance team, you will be responsible for ensuring the highest level of quality in our rocket systems.Key ResponsibilitiesInspect and Test Rocket Components: Perform thorough inspections and tests on rocket components,...

  • Senior Quality Management Specialist

    1 week ago

    Lompoc, California, United States DenMat Holdings, LLC Full time

    Job OverviewPosition SummaryIn this pivotal role, you will be responsible for establishing and executing departmental objectives and strategies that align with the overarching goals of the organization.Key Responsibilities include, but are not limited to:Oversee and manage the operations of Quality Control and Quality Assurance to ensure that company goals...

  • Launch Quality Assurance Specialist

    7 days ago

    Lompoc, California, United States SpaceX Full time

    Job SummaryWe are seeking a highly skilled Launch Quality Assurance Specialist to join our team at SpaceX. As a key member of our quality assurance team, you will be responsible for ensuring the highest level of quality in our rocket systems.Key ResponsibilitiesPerform in-process inspections and final inspections on structural and propulsion components and...

  • Quality Assurance Inspector for Launch Operations

    2 weeks ago

    Lompoc, California, United States SpaceX Full time

    At SpaceX, we believe in a future where humanity explores the cosmos, and we are committed to developing the technologies that will make this vision a reality. Our mission is to enable human life on Mars.LAUNCH QUALITY INSPECTORAs a critical component of our operations, the Launch Quality Inspector serves as the final checkpoint to ensure mission success....

  • Quality Assurance Inspector for Launch Operations

    2 weeks ago

    Lompoc, California, United States SpaceX Full time

    At SpaceX, we believe in a future where humanity explores the cosmos, and we are dedicated to developing the technologies that will make this vision a reality. LAUNCH QUALITY INSPECTORAs a critical component of our mission success, SpaceX quality inspectors serve as the final checkpoint in ensuring the highest standards are met. Your role will involve...

  • Senior Program Manager

    4 days ago

    Lompoc, California, United States 3M Consultancy Full time

    Job Title: Senior Program ManagerLocation: NationwideDuration: Full-TimeSecret Clearance requiredOur client, 3M Consultancy, is seeking a highly skilled Senior Program Manager to join their team in establishing and growing a new services practice within the technology industry. This exceptional opportunity involves joining a team that is expanding an already...

  • Senior Logistics and Supply Chain Strategist

    2 weeks ago

    Lompoc, California, United States SPACE EXPLORATION TECHNOLOGIES CORP Full time

    SENIOR LOGISTICS AND SUPPLY CHAIN STRATEGIST (LAUNCH SITE)The supply chain division at Space Exploration Technologies Corp plays a pivotal role in our operational success. This position is integral to the launch site supply chain team. Key functions of this team encompass procurement, strategic planning, fulfillment, supplier development, quality assurance,...

  • Senior Systems Engineering Specialist

    2 weeks ago

    Lompoc, California, United States ENSCO Full time

    Senior Systems Engineering Specialist RoleENSCO is in search of a Senior Systems Engineering Specialist with a strong background in communication systems and networking technologies for a hybrid work opportunity. This crucial position plays a vital role in Systems Engineering and Integration (SE&I) initiatives to support advanced space exploration and...

  • Electrical Hardware Systems Engineer Senior

    6 days ago

    Lompoc, California, United States Range Generation Next LLC Full time

    Job SummaryWe are seeking a highly skilled Electrical Hardware Systems Engineer Senior to join our team at Range Generation Next LLC. As a key member of our Sustaining Engineering team, you will play a critical role in analyzing complex challenges and developing innovative solutions to meet the needs of our customers.Key ResponsibilitiesDesign and...

  • Senior Environmental Compliance Engineer

    2 weeks ago

    Lompoc, California, United States SpaceX Full time

    Senior Environmental Compliance Engineer (NEPA) at SpaceXSpaceX is driven by the vision of expanding humanity's reach into the cosmos, striving to develop the technologies necessary for human life on Mars.POSITION OVERVIEW:The Senior Environmental Compliance Engineer will play a pivotal role in ensuring adherence to the National Environmental Policy Act...

  • Senior Financial Strategy Consultant

    2 weeks ago

    Lompoc, California, United States The Ladders Full time

    Senior Financial Strategy Consultant **Location:** Hybrid **Role Overview:** As a Senior Financial Strategy Consultant, you will take the helm of a dedicated team focused on Financial Improvement & Audit Remediation (FIAR). Your leadership will guide a group of five professionals in executing thorough internal assessments for a substantial budget within the...

  • Senior Hardware Systems Engineer

    7 days ago

    Lompoc, California, United States Range Generation Next LLC Full time

    Job SummaryWe are seeking a highly skilled Electrical Hardware Systems Engineer Senior to join our team at Range Generation Next LLC. As a key member of our Sustaining Engineering team, you will play a critical role in analyzing complex challenges and developing innovative solutions to meet the needs of our customers.Key ResponsibilitiesDesign and...

  • Senior Mechanical Field Engineer

    2 weeks ago

    Lompoc, California, United States Lockheed Martin Corporation Full time

    Position Overview Company: Lockheed Martin Corporation As a Senior Mechanical Field Engineer, you will play a crucial role in our renowned Advanced Programs division. This position is part of a historic initiative that focuses on pioneering systems development, including innovative design and rapid prototyping of both new solutions and enhancements to...

  • Senior Logistics Engineering Specialist

    2 weeks ago

    Lompoc, California, United States Lockheed Martin Corporation Full time

    Job ID: 669351BR Company Overview: We are Lockheed Martin, a leader in advanced technology and aerospace solutions. Position Title: Senior Logistics Engineering Specialist - Advanced Programs - Level 3 Position Overview: This role is part of our renowned Skunk Works program, which is pivotal to Lockheed's Aeronautics sector, focusing on the development of...

  • Senior Range Systems Analyst

    2 weeks ago

    Lompoc, California, United States Range Generation Next LLC Full time

    Position OverviewThe role of the Senior Range Systems Analyst is pivotal in supporting the operational and maintenance aspects of mission-critical systems that facilitate space launch and tracking for various sectors, including defense and commercial enterprises.This position involves collaborating with a team of skilled professionals dedicated to delivering...

  • Security Specialist II

    3 days ago

    Lompoc, California, United States Watermark Risk Management International, LLC Full time

    Job SummaryWe are seeking a highly skilled Security Specialist II to join our team at Watermark Risk Management International, LLC. As a Security Specialist II, you will play a critical role in ensuring the effective and efficient management of sensitive compartmented information (SCI) and collateral program functions.Key ResponsibilitiesFormulate plans,...

  • Engineering Manager

    4 days ago

    Lompoc, California, United States Range Generation Next LLC Full time

    Job SummaryWe are seeking an experienced Engineering Manager to lead our team of engineers in the development and sustainment of mission-critical systems for the Eastern and Western Launch & Test Range. As a key member of our Sustaining Engineering team, you will be responsible for resolving technical issues, guiding team members, and coordinating with other...

  • Senior Mechanical Project Engineer

    2 weeks ago

    Lompoc, California, United States Amentum Full time

    POSITION OVERVIEW:As a seasoned engineer under the guidance of the Engineering/Safety Supervisor, you will independently assess, analyze, and execute essential technical engineering tasks related to mechanical and systems operations. Your extensive experience and judgment will be pivotal in navigating a variety of concepts, practices, and procedures within...

  • Information Systems Security Manager

    4 days ago

    Lompoc, California, United States Parsons Corporation Full time

    **Job Summary**Parsons Corporation is seeking a highly skilled Information Systems Security Officer to join our team. As an ISSO, you will play a critical role in developing, maintaining, and implementing information security standards, procedures, and guidelines for applications and databases.**Key Responsibilities:**Conduct assessments of systems and...