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Quality Technician II, Aseptic Control (Day Shift - 12-Hour Rotating Schedule)

BioSpace

Olde West Chester (OH)

On-site

USD 10,000 - 60,000

Full time

30 days ago

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Job summary

A leading company is seeking a Quality Technician II for Aseptic Control on a day shift with a 12-hour rotating schedule. The role involves environmental monitoring, documentation, and compliance with regulatory requirements in a sterile manufacturing environment. Ideal candidates will have experience in pharmaceutical production and a strong attention to detail. A comprehensive rewards package is offered, including competitive pay and benefits.

Benefits

Equity
Bonuses
401(k) with match
Healthcare
Flexible time off
Tuition reimbursement

Qualifications

  • Prior experience in a pharmaceutical production environment.
  • Ability to understand, read, write, communicate, and follow instructions in English.

Responsibilities

  • Perform routine sampling activities and associated data entry.
  • Maintain accurate and complete records, ensuring proper documentation practices.
  • Ensure laboratory duties are carried out in accordance with cGMP.

Skills

Attention to Detail
Communication

Education

B.S. in Biology

Tools

MODA
Microsoft Applications

Job description

Quality Technician II, Aseptic Control (Day Shift - 12-Hour Rotating Schedule)

Join to apply for the Quality Technician II, Aseptic Control (Day Shift - 12-Hour Rotating Schedule) role at BioSpace.

Position Summary

This position is responsible for autonomously performing tasks related to environmental monitoring to support regulatory requirements of a sterile manufacturing site. (Day Shift - 12-Hour Rotating Schedule)

Position Responsibilities
  1. Perform routine sampling activities and associated data entry.
  2. Wear gowning, sterile garments, and PPE as required by specific activities.
  3. Read and interpret diagrams, drawings, and other schematics.
  4. Prepare documentation of activities, actions, and results, ensuring proper documentation practices during job activities. Read SOPs and technical documentation.
  5. Maintain accurate and complete records (e.g., laboratory notebooks, quality records, sample receipts).
  6. Complete required training.
  7. Perform visual inspections.
  8. Use MODA to collect and analyze samples.
  9. Guide others on SOPs, control documents, and work instructions. Coordinate activities of support groups.
  10. Ensure laboratory duties are carried out in accordance with cGMP.
  11. Perform regular audits of SOPs and work instructions.
  12. Recommend and initiate activities to maintain area and equipment compliance.
  13. Provide feedback on service and quality issues promptly.
Hours (Day Shift)
  • 6 AM - 6 PM (12-Hour Shift)
  • Rotating 2-2-3 shift schedule
Minimum Qualifications
  • Prior experience in a pharmaceutical production environment.
  • Ability to understand, read, write, communicate, and follow instructions in English.
  • Thorough attention to detail.
  • Capable of keeping accurate records and performing mathematical calculations.
Preferred Qualifications
  • B.S. in biology or related discipline.
  • Working knowledge of MODA, Microsoft applications.
  • Experience in a LEAN manufacturing environment.
  • Knowledge of cGMPs and FDA policies/procedures.

The items described here are representative of those required to perform the essential functions of this job.

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, marital status, veteran status, disability, genetic information, or other protected characteristics.

Resilience offers a comprehensive rewards package including equity, bonuses, 401(k) with match, healthcare, family benefits, insurance, flexible time off, paid holidays, tuition reimbursement, and support for caregiving. The target pay range is $21.50 - $30.50/hour, dependent on location, experience, and qualifications.

We encourage interested candidates to apply and connect with our recruiters to start a conversation about joining Resilience.

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