Quality Assurance Specialist

4 weeks ago

Omaha, United States Insight Recruitment Full time
Job DescriptionJob Description

Are you a skilled Quality Assurance professional with a year of experience under your belt, ready to take your career to the next level? Do you have a passion for process improvement, Corrective and Preventive Actions (CAPA), and perhaps even exposure to ISO 13485 or ISO 9001 standards? If so, we have an exciting opportunity for you to join a dynamic and rapidly growing biotech company right here in Omaha, Nebraska.


About Us:

We are at the forefront of innovation in the biotech industry, constantly pushing the boundaries of what's possible. We are a flourishing biotech company committed to improving lives through cutting-edge research, development, and manufacturing of life-changing products. With a strong emphasis on employee development and promotion from within, we foster a culture that values your growth and success.


Your Role:

As a Quality Assurance Specialist, you will play a pivotal role in ensuring that our products meet the highest quality standards while actively contributing to process improvement initiatives. Your experience and skills in CAPA, and your possible familiarity with ISO 13485 or ISO 9001, will be invaluable in this role. You will work alongside a team of passionate professionals dedicated to maintaining the integrity of our products and processes.


SUMMARY OF RESPONSIBILITIES:

This position will be responsible for quality activities performed in manufacturing, ensuring compliance with regulatory requirements and internal procedures. Under general supervision, this position provides day-to-day quality support to the manufacturing departments.


ESSENTIAL DUTIES AND FUNCTIONS:

  1. Performs diluent checks, incubator temp checks and time checks, etc., as required by process documentation.
  2. Performs batch record/lot file reviews in accordance with good documentation practices and internal procedures in an efficient and timely manner.
  3. Assures that any observations/deviations are properly investigated and explained.
  4. Reviews and approves Nonconforming Material Reports.
  5. Provides support for the CAPA process to include CAPA investigation and closure.
  6. Maintains awareness of activities by routine direct observation of manufacturing processes. Interacts frequently with manufacturing staff to provide quality perspective on routine operations and support system. Addresses conditions/practices with appropriate personnel, documents and reports finding to Management.
  7. Assists departmental supervisor with writing and revising Standard Operating Procedures as necessary.
  8. Maintain Quality System reporting tools, such as error tracking spreadsheets and other documents as requested by management.
  9. Participates in quality and process improvement initiatives and project teams.
  10. Performs all other duties as assigned by manager.


REQUIREMENTS:

  1. Bachelors degree in biology, chemistry or related discipline. Related work experience may substitute for a portion but not the entire education requirement.
  2. One to four years of related work experience in an FDA regulated manufacturing environment preferred.


REQUIRED COMPETENCIES:

  1. High attention to detail.
  2. Strong organizational, time management and multitasking skills.
  3. Demonstrates professionalism and sound judgment.
  4. Strong oral and written communication skills.
  5. Demonstrated analytical and problem-solving skills.
  6. High degree of flexibility and the ability to lead others in adapting to change.

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