Quality Technician II, QC Aseptic

Resilience; Port Union (OH); On-site; USD 30,000 - 43,000; Full time

Benefits offered by this job

Annual bonus program

401(k) plan with company match

Healthcare (medical, dental, vision)

Family building benefits

Life and disability insurance

Paid vacation

Job summary

Resilience, a technology-focused biomanufacturing company, seeks a Quality Technician II to support aseptic manufacturing operations with environmental monitoring and microbial sampling in classified and non-classified areas. You will document activities, follow SOPs, and ensure cGMP compliance while maintaining accurate records.

The role requires 1+ years in pharma/biotech or cGMP environments, attention to detail, and proficiency with LIMS/NOVATEK/MODA software.

Qualifications

• Follow written procedures, SOPs and work instructions with minimal supervision.
• Strong attention to detail and ability to keep accurate records.
• English language proficiency with ability to read, write and follow instructions.
• 1+ years of experience in a pharmaceutical, biotechnology, or cGMP-regulated environment.
• Working knowledge of LEAN manufacturing principles.
• Knowledge of cGMPs and FDA policies/procedures.

Responsibilities

• Document activities, actions and results; read SOPs and keep accurate records.
• Perform visual inspections and routine sampling using the Environmental Monitoring System.
• Follow SOPs, control documents and work instructions; maintain cGMP-compliant lab duties.
• Maintain work area and equipment per SOPs and cGMP; report deviations to supervisor.
• Audit SOPs and work instructions; suggest activities to maintain compliance.
• Support training of new technicians.

Skills

Environmental monitoring

Microbial sampling

Documentation

cGMP compliance

LEAN manufacturing

Microsoft applications

LIMS

MODA

Novatek

Education

High school diploma or equivalent

1+ years pharma/biotech/cGMP manufacturing

Tools

LIMS

MODA

Novatek

Microsoft applications

Job description

A career at Resilience is more than just a job - it's an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

For more information, please visit www.resilience.com

The Quality Technician II, QC Aseptic Control Micro - Aseptic Control Technician performs environmental monitoring and microbial sampling activities in classified and non-classified areas, including Class 100/ISO 5 aseptic environments, in support of sterile manufacturing operations at the WCH site. Working under established procedures and SOPs, this role collects and analyzes environmental samples, maintains accurate cGMP documentation, and ensures laboratory activities are conducted in a state of compliance.

Job Responsibilities

Core Responsibilities

• Document activities, actions, and results per documentation practices; read SOPs and technical documentation as required, and maintain accurate, complete records (e.g., laboratory notebooks, quality records, sample receipts).
• Perform visual inspections and routine sampling activities, including using the Environmental Monitoring System to collect and analyze samples, with associated data entry.
• Follow SOPs, control documents, and work instructions; perform laboratory duties consistent with cGMP requirements.
• Maintain work area and equipment in a state of compliance with applicable SOPs and cGMP requirements; report deviations or non-conformances to supervisor.
• Audit SOPs and work instructions; recommend and initiate activities to keep area and equipment in a state of compliance.
• Support the training of new technicians

Experience & Education

Minimum Qualifications

• Ability to follow written procedures, SOPs and work instructions with minimal supervision, escalating issues as needed.
• Strong attention to detail, with the ability to keep accurate records and perform mathematical calculations.
• Ability to effectively read, write, speak, and follow instructions English.

Preferred Qualifications

• High school graduate, vocational school graduate, or equivalent.
• 1+ years of experience in a pharmaceutical, biotechnology, or cGMP-regulated manufacturing environment.
• Working knowledge of Microsoft applications, MODA, LIMS, Novatek, or equivalent sampling and testing software
• Experience working in a LEAN manufacturing environment.
• Knowledge of cGMPs and FDA policies/procedures.

Physical & Work Environment

• This is primarily a non-Sedentary role that can include climbing, kneeling, standing, repetitive motion, temperature changes, exerting up to 100 pounds of force to move objects, and potential exposure to area chemicals requiring handling precautions per SOP.
• Use of personal protective equipment, which can include respirators, Personal Air Purifying Respirators [PAPR], gowns, gloves, face protection, other barrier equipment, etc.
• Using a computer keyboard, mouse, or other electronic/laboratory device; interpreting sounds and associated meanings at volume levels consistent with interpersonal or group conversations; interpreting letters and numbers when viewed on a computer screen, monitor, reports and other documents; identifying and distinguishing colors.
• All employees are expected to adhere to the Quality Management System established in the Quality Manual, Quality Policy, Standard Operating Procedures, Current Good Manufacturing Practices, and any other applicable regulations and standards to the duties within their role.

Work Schedule

6am - 630pm working a 12-hour 2/2/3 schedule.

The work schedule listed reflects the employee's expected schedule at the time of hire. The Company reserves the right to modify work schedules at any time, including a request to work overtime, with or without notice, based on business needs, operational requirements, or other considerations. Nothing in this description creates a guarantee of specific hours, days, or shift assignments. This role requires the ability to provide 24/7 on-call support as needed.

Sponsorship or support for work authorization, including visas, is not available for this position.

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.

Resilience offers employees a robust total rewards program including an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, paid vacation, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $21.50 - $30.50 per hour. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate's geographical location, relevant experience, qualifications, skills and knowledge.