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Quality Engineer Job Opening In Worcester – Now Hiring Katalyst HealthCares & Life Sciences


Job description


Responsibilities:
  • Ensure proper integration and support of quality regulations: drug, biologics, device and/or combination products.

  • Assist project teams in planning, preparation, review and approval of quality documentation.

    Responsible for implementing and maintaining the effectiveness of the quality system for drug, biologics, device and/or combination products including compliance with Corporate policies, processes and procedures.

  • Apply effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality system.

  • May be required to prepare and present data during regulatory audits (FDA, EMA, Anvisa, etc) and internal audits.

  • Support the interrelated function activities including design control with R&D, Manufacturing Science and Technology (MS&T), Supply Chain, Program Management, Commercial, Medical, Pharmacovigilance, and Regulatory Affairs.

  • Coordinate quality system elements, training, continuous improvement, and tactical support across functions, plants, and affiliates.

  • Support new product introduction for pharmaceutical products, medical devices, or combination products.

  • Support design changes to existing medical devices and combination products.

  • Interact with internal and external partners for development of best practices in our quality systems and procedures.

  • Perform assessments to determine compliance to processes and regulations to identify potential gaps and mitigate and implement improvements within our quality system.

  • Oversee the implementation and management of training and education programs for various aspects of quality assurance.

  • Requirements:
  • years relevant experience.

  • BS Degree.

  • Pharmaceutical products, medical devices, combination products and biologics.

  • This role will support the strategic direction to ensure business objectives are met.

  • Specific areas of support may include the Product QA, Manufacturing QA, Supplier/Incoming QA, Process Qualification/Validation, Compendia management and CAPA.

  • This position will ensure that all product, process or system related quality activities from raw material inspection through shipment of final product are following local, Corporate, and governmental regulations.

  • Focus on process qualification PPQ support and review activities on range of topics from process controls to raw material controls.

  • Familiarity with sap, oracle (Inventory management).

  • Will support biologics products (not small molecule products).

  • QA/QC review background.

  • Manufacturing or quality control exp.

  • working with managers in PQA team.

  • Batch records.

  • Overseeing manufacturing process of biologics.

  • Process qualification protocols.

  • yrs exp needed.

  • Document review.

  • Pharma driven candidate needed.

  • Familiarity with Track wise or Veeva exp is a plus.

  • Familiarity with biologics manufacturing (Biologics industry exp needed).

  • Exp with validation documents (process validation documents, method validation documents).

  • Exp with document review and associated skills with that.


  • Required Skill Profession

    Engineers


    • Job Details

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    Unlock Your Quality Engineer Potential: Insight & Career Growth Guide


    Real-time Quality Engineer Jobs Trends (Graphical Representation)

    Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph here. Uncover the dynamic job market trends for Quality Engineer in Worcester, United States, highlighting market share and opportunities for professionals in Quality Engineer roles.

    187113 Jobs in United States
    187113
    72 Jobs in Worcester
    72
    Download Quality Engineer Jobs Trends in Worcester and United States

    Are You Looking for Quality Engineer Job?

    Great news! is currently hiring and seeking a Quality Engineer to join their team. Feel free to download the job details.

    Wait no longer! Are you also interested in exploring similar jobs? Search now: .

    The Work Culture

    An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at Katalyst HealthCares & Life Sciences adheres to the cultural norms as outlined by Expertini.

    The fundamental ethical values are:

    1. Independence

    2. Loyalty

    3. Impartiapty

    4. Integrity

    5. Accountabipty

    6. Respect for human rights

    7. Obeying United States laws and regulations

    What Is the Average Salary Range for Quality Engineer Positions?

    The average salary range for a varies, but the pay scale is rated "Standard" in Worcester. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.

    What Are the Key Qualifications for Quality Engineer?

    Key qualifications for Quality Engineer typically include Engineers and a list of qualifications and expertise as mentioned in the job specification. The generic skills are mostly outlined by the . Be sure to check the specific job listing for detailed requirements and qualifications.

    How Can I Improve My Chances of Getting Hired for Quality Engineer?

    To improve your chances of getting hired for Quality Engineer, consider enhancing your skills. Check your CV/Résumé Score with our free Tool. We have an in-built Resume Scoring tool that gives you the matching score for each job based on your CV/Résumé once it is uploaded. This can help you align your CV/Résumé according to the job requirements and enhance your skills if needed.

    Interview Tips for Quality Engineer Job Success

    Katalyst HealthCares & Life Sciences interview tips for Quality Engineer

    Here are some tips to help you prepare for and ace your Quality Engineer job interview:

    Before the Interview:

    Research: Learn about the Katalyst HealthCares & Life Sciences's mission, values, products, and the specific job requirements and get further information about

    Other Openings

    Practice: Prepare answers to common interview questions and rehearse using the STAR method (Situation, Task, Action, Result) to showcase your skills and experiences.

    Dress Professionally: Choose attire appropriate for the company culture.

    Prepare Questions: Show your interest by having thoughtful questions for the interviewer.

    Plan Your Commute: Allow ample time to arrive on time and avoid feeling rushed.

    During the Interview:

    Be Punctual: Arrive on time to demonstrate professionalism and respect.

    Make a Great First Impression: Greet the interviewer with a handshake, smile, and eye contact.

    Confidence and Enthusiasm: Project a positive attitude and show your genuine interest in the opportunity.

    Answer Thoughtfully: Listen carefully, take a moment to formulate clear and concise responses. Highlight relevant skills and experiences using the STAR method.

    Ask Prepared Questions: Demonstrate curiosity and engagement with the role and company.

    Follow Up: Send a thank-you email to the interviewer within 24 hours.

    Additional Tips:

    Be Yourself: Let your personality shine through while maintaining professionalism.

    Be Honest: Don't exaggerate your skills or experience.

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    Body Language: Maintain good posture, avoid fidgeting, and make eye contact.

    Turn Off Phone: Avoid distractions during the interview.

    Final Thought:

    To prepare for your Quality Engineer interview at Katalyst HealthCares & Life Sciences, research the company, understand the job requirements, and practice common interview questions.

    Highlight your leadership skills, achievements, and strategic thinking abilities. Be prepared to discuss your experience with HR, including your approach to meeting targets as a team player. Additionally, review the Katalyst HealthCares & Life Sciences's products or services and be prepared to discuss how you can contribute to their success.

    By following these tips, you can increase your chances of making a positive impression and landing the job!

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