How to Apply:

Interested candidates should send their resume, title(s) of job for which they wish to be considered, and salary requirements to hr@origenbio.com.   Unfortunately, due to the volume of candidates, it is not possible to follow-up with all applicants, but we invite you to visit OriGen’s Career Page often, as we are updating with new opportunities frequently.  We look forward to hearing from you.

OriGen Biomedical manufactures essential, life-saving products.  As such, OriGen is an essential business and some jobs may be required to work onsite. Your health and safety is important, and while we take pride in our everyday practices to maintain a clean and sanitary environment within our facilities, at present, we have implemented additional measures that reflect the recommended standards of the Centers for Disease Control and Prevention (CDC) in response to the coronavirus.

Current Job Openings:

Production Trainer

Summary

The Production Trainer works as part of the production team at OriGen Biomedical. The position provides manufacturing support to ensure continuous compliance with training to cGMP requirements and standards.

Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Competencies

  • Knowledge of cGMP guidelines and regulations.
  • Proven skills in coordinating and managing day to day tasks and working in collaboration to accomplish deadlines and objectives.
  • Personal leadership skills and fosters working in a team environment.
  • Works cross functionally to complete projects and training.
  • Exercises judgment within broadly defined practices and policies
  • Knowledge of and skills in using computer software and hardware applications, including Microsoft Word and Excel
  • Outstanding communication skills, both written and oral, and will be expected to communicate directly with production supervisors, quality and production personnel

Supervisory Responsibility

This position has no supervisory responsibilities.

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

This job periodically operates in a cleanroom environment. Cleanroom environment requires personnel to wear personal clothing completely covering the legs; company-provided cleanroom coat, bouffant, face mask, and gloves.

Physical Demands

  • Position may require frequent communication and walking to other areas in which designated personal protective equipment will be required.
  • Majority of time will be spent manipulating data at computer, sitting, reaching, bending, and twisting.
  • Employee may occasionally lift and/or move up to 10 pounds.
  • This position has been approved for relocation assistance.

Position Type and Expected Hours of Work

This is a full-time position.

Days and hours of work are typically Monday through Friday, 9:00 a.m. to 5:30 p.m. In some cases, additional work hours may be required.

Travel

0%

Preferred Education and Experience

High school diploma plus 5 years of production and training experience.

Additional Eligibility Qualifications

None required for this position.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

For more information or to apply, please email a resume to Origen Jobs.  Resumes may also be submitted by fax or mail. Click here  for our contact information.

QA Engineering Manager

Position Summary

The QA Engineering Manager is responsible for all quality system and product quality activities for OriGen Biomedical, including ensuring compliance to global quality system regulations and standards such as 21 CFR 820, ISO 13485:2016 and MDSAP. This position oversees the quality team and manages the daily activities associated with releasing high quality products under a compliant quality management system.

Essential Duties and Responsibilities

The essential duties and responsibilities of this position include, but are not limited to the following:

  • Leads a team of quality personnel, including specialists, and engineers, acting as a mentor and facilitating effective communication and workload/priority management
  • Ensure effectiveness of the quality management system, including planning, managing and executing quality policies, procedures, and programs
  • Ensure compliance of the quality management system with global regulations and standards
  • Provides advice and knowledge in regard to interpreting cGMP/QSR guidelines and regulations
  • Evaluate the performance of the production process and quality of resulting products to improve existing methods of operation
  • Identify and guide areas of QMS improvement and enhancement to meet both the needs of the organization and any new or changing regulatory requirements
  • Coordinate internal and external quality system audits, including those from regulatory authorities, notified bodies, and customers
  • Manage the complaint and CAPA processes, including efficient resolution of complaints and implementation of appropriate corrective and preventive actions to correct or prevent deficiencies
  • Carry out vendor qualification and act as primary contact for customers wanting to qualify OriGen as a vendor
  • Manage document and change control procedures, as well as the training program to ensure all employees maintain training to pertinent procedures
  • Proactively looks for opportunities to identify change, increase efficiency, influence decisions and deliver results while ensuring compliance
  • Develops, modifies, and drives towards meeting quality metrics that successfully measure the output and adequacy of the quality system
  • Reports progress, issues, challenges, and opportunities to the Director of RA/QA, gathering input, feedback and support as needed to achieve quality goals

Supervisory responsibility

  • Supervises department of 3 and growing
  • Develops and optimizes department schedules
  • Maintains training of current QA staff
  • Recruits and trains new QA personnel
  • Works closely with other supervisory personnel

Competencies

  • Building Relationships: proven leadership, including ability to motivate, teach/mentor and delegate
  • Teamwork – build a team and be a member of the team
  • Demonstrated interpersonal skills, including ability to work cross-functionally to achieve business goals
  • Conflict Resolution
  • Effective communication skills (verbal and written)
  • Performance management
  • Sound critical thinking, problem solving and independent decision making
  • Adaptability/ flexibility – open to others thoughts/ideas
  • Self-awareness – ability to give and receive feedback and regulate emotions
  • Strong organization and time management skills
  • Proactive and self-starter

Minimum Qualifications (Knowledge, Skills, and Abilities)

  • Bachelor’s degree in Science, or equivalent
  • 6 years professional work experience Quality Assurance
  • 2 years direct supervisory/ leadership experience
  • Quality Systems knowledge in a regulated environment, including subject matter expert knowledge in 21 CFR 820 and ISO 13485:2016

Preferred Qualifications

  • Experience with both quality system and quality engineering/ product quality
  • Experience and sound knowledge in MDSAP requirements and audits
  • Experience working in a manufacturing environment with ISO-qualified cleanrooms

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by any employee to successfully perform the essential job duties and responsibilities of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the duties of this position, the employee is regularly required to talk and hear. The employee is frequently required to use hands, fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, and the ability to adjust focus. The noise level in the work environment is usually moderate.

QA Specialist

Position Summary

The QA (Quality Assurance) Specialist develops programs and procedures to support and implement the Quality Management System for OriGen products and processes. This includes creation of documents and reports Quality Metrics on both product quality and the effectiveness of the Quality Management System. Working with the QA Manger (and/or RA/QA Director), they will create a system of continuous improvement for both products and quality reporting.

Responsibilities and Essential Functions

Quality activities includes, but is not limited to:

  • Write, revise, and approve documents and reports related to quality system activities.
  • Works to increase outgoing product quality.
  • Works with Quality and Engineering to maintain and improve incoming material quality.
  • Works with QA staff to maintain and increase competency and efficiency, including quality training within the company.
  • Ensures the initiation, review, and maintenance of the Quality Management System, including the electronic Quality Management System (eQMS), and train others in its use.
  • Assist with document control activities.
  • Assist with risk assessment/ risk analysis.
  • Performs investigations and root cause analysis for CAPA’s, Complaints, NCR’s as well as initiate and assist with Deviations and Reworks, including trending.
  • Conducts and/or assists with Internal Audits.
  • Prepares for and participates in inspections/audits by external auditing organizations and customers, field actions including FSCAs and recalls and development of Management Review content.
  • Support manufacturing batch release for sterile products.

Competencies

  • Thorough knowledge of 21 CFR 820, ISO 13485:2016 and MDSAP requirements.
  • Familiar with complaint handling, CAPA, Non-conforming material processes, including root cause analysis techniques.
  • Familiar with using an eQMS system.
  • Self-starter managing day to day tasks and working in collaboration to accomplish deadlines and objectives.
  • Interpersonal skills necessary to work effectively in a team environment.
  • Works cross functionally to complete projects and testing.
  • Exercises judgment within broadly defined practices and policies.
  • Exceptional skills in using computer software and hardware applications, including Microsoft Word and Excel.
  • Outstanding communication skills, both written and oral, in communicating across the organization and outside of the organization.

Required Education and Experience

  • Bachelor’s Degree or equivalent in life science or engineering field.
  • Minimum of 3 years’ experience in medical device quality assurance discipline: knowledge of domestic and international medical device quality system regulations and standards.
  • Certified Internal Auditor (ASQ or similar program).
  • Experience in ERP and eQMS/eDMS systems.

Supervisory Responsibility

This position has no supervisory responsibilities; however, the individual may be required to lead projects and ensure participants meet deadlines.

Position Type and Expected Hours of Work

This is a full-time position.
Days and hours of work are typically Monday through Friday, 8:30 a.m. to 5 p.m. In some cases, additional work hours may be required.

Travel

<10%

Work Environment

  • This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
  • This job periodically operates in a cleanroom environment. Cleanroom environment requires personnel to wear personal clothing completely covering the legs; company-provided cleanroom coat, bouffant, face mask, and gloves.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential job duties and responsibilities of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the duties of this position, the employee is regularly required to talk and hear. The employee is frequently required to use hands, fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, and the ability to adjust focus. The noise level in the office environment is usually minimal.

Salary:

Commensurate with Experience.

Cleanroom Tech for Medical Device Production - Morning and Evening Shift

Morning Shift: Work hours: five days, 8 hour shifts (Monday-Friday 5:45am – 2:15pm).

Evening Shift: Work hours: four days, 10 hour shifts (Monday-Thursday  2:15pm – 12:45am). 

The Clean Room Tech (CRT) is responsible for: assembly, testing and packaging of medical devices and components. Required to understand and comply with drawings, written procedures, batch records and apply these standards to their work.

Essential Duties and Responsibilities

The essential duties and responsibilities of this position include, but are not limited to the following:

  • Ability to meet production schedules and deadlines according to quality standards
  • Ability to work in a flexible and changing environment
  • Ability to follow detailed written and verbal instructions
  • Ability to learn multiple tasks and train in other areas as needed
  • Ability to work with a variety of tools and equipment
  • Ability to maintain all logs, paperwork and forms accurately
  • Required to understand, access and make entries to documents on the company Electronic Document System
  • Ability to accurately perform job duties with minimum supervision
  • Ability to adhere to cleanroom dress code and policies
  • Ability to work in a multi-cultural team environment and be a team player
  • Ability to work in a cleanroom environment for extended periods of time
  • Punctual and Reliable!!

Required Skill Sets

  • Must be detailed oriented and be able to focus on a repetitive task for long periods of time
  • Must be proficient on computer, possessing basic navigation and program knowledge
  • Must be able to absorb, assimilate and accurately recall/locate and retain large quantities of data/information
  • Must be able to read, write, speak and fully understand English

Competencies

  • Adaptability/Flexibility
  • Ethical Conduct/Integrity
  • Communication/Listening
  • Detail-Oriented
  • Interpersonal skills
  • Personal Effectiveness
  • Teamwork

Minimum Qualifications (Knowledge, Skills, and Abilities)

  • Basic computer navigation and program knowledge
  • Strong organization and time management skills with the demonstrated ability to meet deadlines
  • Pays very close attention to detail
  • Ability to work independently and within a team environment  

Preferred Qualifications

  • Prior Clean Room experience preferred

Compensation

Based on experience and ability