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

BioSpace; Olde West Chester (OH); On-site; USD 10,000 - 60,000; Full time

Job summary

Join a forward-thinking biomanufacturing company as a Quality Technician II. This role focuses on ensuring regulatory compliance in a sterile environment, conducting routine sampling, and maintaining accurate records. You'll be part of a dedicated team working on the night shift, contributing to the transformation of medicine production. With a strong emphasis on quality and attention to detail, this position offers an exciting opportunity to grow in a dynamic industry. Enjoy comprehensive benefits and a competitive pay range as you support high-tech manufacturing networks.

Benefits

Healthcare

401(k)

Bonuses

Qualifications

• Experience in a pharmaceutical production environment is essential.
• Strong capability to maintain accurate records and follow SOPs.

Responsibilities

• Conduct routine sampling and data entry for environmental monitoring.
• Ensure compliance with cGMP standards and conduct SOP audits.

Skills

Attention to Detail

Communication Skills

Mathematical Calculations

Education

B.S. in Biology or Related Field

Tools

MODA

Microsoft Applications

Job description

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

Join us at BioSpace as a Quality Technician II, Aseptic Control (Night Shift - 12-Hour Rotating Schedule). We are a technology-driven biomanufacturing company committed to transforming medicine production and building resilient, high-tech manufacturing networks.

Position Overview & Responsibilities

This role involves performing environmental monitoring tasks to support regulatory compliance in a sterile manufacturing environment. Responsibilities include:

1. Conducting routine sampling and data entry.
2. Wearing appropriate gowning, sterile garments, and PPE.
3. Interpreting diagrams, drawings, and schematics.
4. Documenting activities, ensuring proper documentation practices, and reading SOPs and technical documents.
5. Maintaining accurate records such as laboratory notebooks and quality records.
6. Completing required training and performing visual inspections.
7. Using MODA for sample collection and analysis.
8. Guiding others on SOPs and work instructions, and coordinating support activities.
9. Ensuring laboratory and equipment compliance with cGMP standards.
10. Conducting SOP audits and recommending activities to maintain compliance.
11. Providing feedback on service and quality issues promptly.

Work Hours (Night Shift)

• 6:00 PM - 6:30 AM
• Shift pattern: 2/2/3 (12-hour rotating shift)

Minimum Qualifications

• Experience in a pharmaceutical production environment.
• Ability to read, write, communicate, and follow instructions in English.
• Strong attention to detail.
• Capability to maintain accurate records and perform mathematical calculations.

Preferred Qualifications

• B.S. in biology or related field.
• Knowledge of MODA and Microsoft applications.
• Experience in a LEAN manufacturing environment.
• Understanding of cGMPs and FDA policies.

Resilience is an Equal Opportunity Employer. We offer comprehensive benefits including healthcare, 401(k), bonuses, and more. Our pay range is $21.50 - $30.50/hour, dependent on experience and location.

Interested candidates are encouraged to apply and connect with our recruiters to start a conversation about joining our team.