Technician, Quality

Antylia Scientific; Metuchen (NJ); On-site; USD 10,000 - 60,000; Full time

Job summary

A leading biotechnology company is seeking a Technician, Quality to ensure compliance with quality standards and processes. The role involves conducting QC checks, managing documents, and participating in improvement initiatives. Ideal candidates will have an associate's degree and relevant experience, coupled with strong communication and organizational skills.

Benefits

Medical, Dental, Vision Insurance

Disability Insurance

Life Insurance

401(k) company match

Paid Time Off (15 days annually)

Paid Holiday time (10 company-designated days)

Tuition Assistance

Qualifications

• 1+ year of previous related experience required.
• Prior experience with ISO 13485 and 21 CFR 820 a plus.
• Ability to work independently and under deadlines.

Responsibilities

• Perform final QC checks on outgoing product shipments.
• Release incoming materials and finished products according to specifications.
• Assist with document control and training activities.

Skills

Good communication skills

Organizational skills

Ability to multitask

Education

Associate’s Degree in related field

Job description

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Position Summary

Responsible for quality system processes designed to ensure continuous flow of incoming and outgoing materials consistent with established standards and regulations including FDA 21 CFR 820, ISO 13485, and appropriate EU regulations . Ensures compliance in QC areas including review and generation of information for incoming materials and product release. Ensures compliance in the areas of equipment qualification and calibration, supplier qualification and management, and document control as needed. Ensures continued improvement and compliance with relevant FDA, ISO 13485, and EU regulations by participating in audit responses, and deviation, nonconformance, complaint, and CAPA processes as necessary. Promotes and participate in training activities related to the quality management system and product quality, safety and efficacy.

Job Title: Technician, Quality

Reports To: Supervisor, Quality

Position Location: Metuchen, NJ

FLSA Status: Non-Exempt

Position Summary

Responsible for quality system processes designed to ensure continuous flow of incoming and outgoing materials consistent with established standards and regulations including FDA 21 CFR 820, ISO 13485, and appropriate EU regulations . Ensures compliance in QC areas including review and generation of information for incoming materials and product release. Ensures compliance in the areas of equipment qualification and calibration, supplier qualification and management, and document control as needed. Ensures continued improvement and compliance with relevant FDA, ISO 13485, and EU regulations by participating in audit responses, and deviation, nonconformance, complaint, and CAPA processes as necessary. Promotes and participate in training activities related to the quality management system and product quality, safety and efficacy.

Key Responsibilities

• Responsible for performing final QC checks on all outgoing product shipments, which includes reviewing and assuring accuracy of both documentation and product.
• Responsible for release of incoming materials, manufactured materials, and finished products according to written specifications.
• Assist with the maintenance of the equipment qualification and calibration program and upkeep of the equipment database.
• Assist the QA/QC Manager with review and filing of calibration certificates, out of tolerance reports, deviations, and SCARs as necessary.
• Assist with the development and implementation of company SOPs as assigned.
• Perform document control and training activities as assigned.
• Requires an ability to complete cGMP documentation accurately, in accordance with standard operating procedures, and in a timely manner.
• Requires an ability to work independently to accomplish given tasks within given timelines.
• Requires an ability to multitask and adjust to changing priorities.
• Must report any deviations or nonconformities immediately to a Manager or Director.
• Other duties as assigned.
  
  

Education

• Associate’s Degree in related field or equivalent work experience
  
  

Experience

• 1 or more years of previous related experience
  
  

Minimum Requirements/Qualifications

• Good communication and organizational skills and ability to multitask.
• Prior experience with ISO 13485 and 21 CFR 820 a plus.
• Thrives in a fast-paced, collaborative environment, efficiently works under pressure, within deadlines or other time essential constraints
• Excellent communication skills, both written and verbal, to clearly and concisely communicate to all levels of the organization
• Strong work ethic and an ability to excel within a rapidly changing and growing organization
  
  

Physical Requirements/Working Conditions

• Control exposures to hazardous chemicals & other safety hazards such as:
• Carcinogens.
• Strong and obnoxious fumes.
• Sharp and dangerous blades and needles.
• Biohazard exposure to specimens.
  
  

Compensation & Benefits

• Salary Range: $23/hr-$26/hr, depending on location, experience, and qualifications.
• Benefits coverage begins day 1, including the following:
• Medical, Dental, Vision Insurance
• Disability Insurance
• Life Insurance
• 401(k) company match
• Paid Time Off (15 days annually)
• Paid Holiday time (10 company-designated days)
• Tuition Assistance
• Additional benefits available with company package
  
  

This position has not been approved for Relocation Assistance.

The above statements are intended to describe the general nature and level of the work being performed by people assigned to this job. They are not an exhaustive list of all of the duties and responsibilities associated with it.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Biotechnology

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