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Quality Assurance Associate

The Quality Assurance Associate is responsible for routine inspection and testing of raw materials and components as well as of final product for Cresilon’s products in the Animal and Human Health industries. This position requires a strong attention to detail as the individual will be responsible for identifying deviations in product quality or safety and ensuring compliance with local, state, and federal regulations, including current Good Manufacturing Practices (cGMP).

Responsibilities:

  • Sample and perform visual inspection of final products and raw materials. Perform other testing under the direction of QA Operations Manager.
  • Perform line clearance activities and in-process inspections.
  • Monitor routine manufacturing operations for conformance to applicable procedures (see Gowning Qualification requirements below)
  • Transfer materials between facilities (see lifting requirements below)
    • Facility 1 of 2: 122 18th Street, Brooklyn, NY 11215
    • Facility 2 of 2: 87 35th Street, Suite 603/604/6R, Brooklyn, NY 11232
  • Operate testing equipment such as force testers, torque testers, and balances.
  • Report all deviations in product, components, raw materials, and equipment per their relevant procedures
  • Perform document control activities, including but not limited to printing logbooks and batch records.
  • Transcribe data into digital systems for tracking Quality Metrics.
  • Batch record review & support routine batch disposition

 

Education: High School Diploma or Equivalent (2- or 4-year degree in Engineering, Science, or Technology/Biotechnology preferred)

  • Required experience in GMP and FDA regulated environments (ISO 13485:2016 preferred)
  • Ability to be Gowning Qualified per Cresilon’s SOP.
  • 1 year experience in regulated industry highly desirable
  • Ability to lift, walk, stand, reach, pull and push

·       Paid Vacation, Sick, & Holidays 

·       Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage

·       Company Paid Life and Short-Term Disability Coverage 

·       Work/Life Employee Assistance Program

·       401(k) & Roth Retirement Savings Plan with company match up to 5%

·       Monthly MetroCard Reimbursement

The salary for this role is $25/Hour

Cresilon is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time. 

 

Average salary estimate

$52000 / YEARLY (est.)
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$52000K
$52000K

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What You Should Know About Quality Assurance Associate, Cresilon, Inc.

If you're looking to jumpstart your career in the quality assurance field, the Quality Assurance Associate position at Cresilon might be the perfect fit for you! Located in the heart of Brooklyn, Cresilon is dedicated to delivering top-quality products in both the Animal and Human Health industries. As a Quality Assurance Associate, your primary responsibility will involve inspecting and testing raw materials as well as the final products to meet rigorous safety standards. You'll need a keen eye for detail since spotting even the smallest deviation in product quality is crucial. You'll work closely with the QA Operations Manager, performing various tests and ensuring compliance with state and federal regulations, including current Good Manufacturing Practices (cGMP). With responsibilities ranging from conducting visual inspections to operating specialized testing equipment, no two days will be the same. You'll also be involved in documentation processes, transferring materials, and supporting routine batch dispositions. The ideal candidate will have a high school diploma with experience in a regulated environment—preferably one aligned with GMP/FDA standards. Additionally, Cresilon offers a competitive salary of $25/hour, along with a comprehensive benefits package that includes paid vacation, healthcare coverage, and a 401(k) plan with a company match. Join a team that values diversity and inclusion, and be part of a workplace committed to making a difference!

Frequently Asked Questions (FAQs) for Quality Assurance Associate Role at Cresilon, Inc.
What are the responsibilities of a Quality Assurance Associate at Cresilon?

A Quality Assurance Associate at Cresilon plays a vital role in ensuring the safety and quality of products. Key responsibilities include performing visual inspections, conducting testing of raw materials and final products, monitoring manufacturing operations, and ensuring compliance with local and federal regulations, including cGMP. The associate will also be required to operate various testing equipment and maintain accurate documentation through digital systems.

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What qualifications are needed for the Quality Assurance Associate position at Cresilon?

To qualify for the Quality Assurance Associate role at Cresilon, candidates should have at least a high school diploma or equivalent, while a 2 or 4-year degree in Engineering, Science, or Technology/Biotechnology is preferred. Experience in GMP and FDA-regulated environments is essential, along with the ability to comply with Cresilon's gowning qualification procedures. A minimum of one year of relevant industry experience is highly desirable.

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What benefits does Cresilon offer to Quality Assurance Associates?

Cresilon offers an excellent benefits package for Quality Assurance Associates, including paid vacation, sick leave, and holidays. Additional benefits include medical, dental, and vision insurance options, FSA benefits, a 401(k) plan with company match, and monthly MetroCard reimbursement. Employees also have access to a work/life Employee Assistance Program and company-paid life and disability coverage.

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Is there room for career growth as a Quality Assurance Associate at Cresilon?

Absolutely! As a Quality Assurance Associate at Cresilon, you will have numerous opportunities for professional growth. The experience gained in the regulated environment and the skills developed in inspecting and testing products will open doors for advancement within the company. You will also gain valuable insights into quality metrics, which can be beneficial for career progression.

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What are the working conditions like for a Quality Assurance Associate at Cresilon?

Quality Assurance Associates at Cresilon work in a dynamic environment, primarily based in Brooklyn. The role involves various physical activities such as lifting, standing, and operating testing equipment. The company fosters a collaborative culture where employees are encouraged to communicate and work together to maintain high-quality standards. Cresilon also emphasizes safety and compliance with regulations to ensure a secure workplace.

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Common Interview Questions for Quality Assurance Associate
What do you understand about the role of a Quality Assurance Associate?

In preparation for your interview, it's essential to discuss how a Quality Assurance Associate is responsible for ensuring product quality and safety through inspections and testing as per regulatory standards. Emphasize your willingness to identify deviations and adhere to cGMP principles.

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Can you describe your experience working in a regulated environment?

Provide specific examples of your previous roles or internships that involved quality assurance or compliance in regulated settings like FDA or ISO. Highlight the skills you developed through these experiences and how they relate to the responsibilities at Cresilon.

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How do you ensure attention to detail in your work?

Explain your methods for maintaining a high level of attention to detail, such as using checklists, double-checking your work, and taking breaks to clear your mind. Specific examples of how this has helped you in past roles will strengthen your answer.

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What type of testing equipment have you used in previous positions?

Discuss your familiarity with various testing equipment relevant to quality assurance, such as force testers and balances. If applicable, describe how you used them to perform tests and the outcomes of those assessments.

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How do you handle discrepancies in product quality?

Share your approach to handling discrepancies by detailing steps you would take, such as conducting thorough investigations, documenting findings, and communicating with relevant teams. Emphasize the importance of root cause analysis and corrective actions.

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What strategies do you use to manage your time effectively in a busy environment?

Discuss techniques like prioritizing tasks, using project management tools, or breaking larger tasks into smaller, manageable parts. Mention any experience where effective time management helped you meet deadlines in your past roles.

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How familiar are you with cGMP regulations?

During your interview, showcase your understanding of cGMP regulations and how they impact quality assurance practices. If you have hands-on experience with these procedures, ensure to mention it as it can set you apart from other candidates.

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Can you give an example of a time when you had to work as part of a team?

Provide an example that highlights your collaborative skills, possibly during a project where quality assurance practices were critical. Discuss the dynamics of the team and how you contributed to achieving a common goal.

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What made you interested in the Quality Assurance field?

Share your motivation for pursuing a career in Quality Assurance. Whether it’s your passion for ensuring products meet the highest standards, your interest in safety regulations, or a desire to contribute to the health industry, be honest and articulate.

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How do you stay updated with the latest industry trends and regulations?

Explain your methods for staying current with industry standards, such as attending webinars, participating in professional networks, or reading relevant publications. This demonstrates your commitment to continuous learning in the Quality Assurance field.

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Cresilon is a biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company's proprietary hydrogel technology. Established in 2010, Cresilon is headquartered in Brooklyn, United States.

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Full-time, on-site
DATE POSTED
January 8, 2025

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