Analyst II, Quality Control (Night Shift)

Resilience; Port Union (OH); On-site; USD 60,000 - 86,000; Full time

Benefits offered by this job

Annual bonus

401(k) with company match

Medical, dental and vision insurance

Paid vacation

Job summary

Resilience, a technology-focused biomanufacturing company, seeks a on-the-floor sampling and QC data-review specialist to ensure cGMP compliance. The role involves testing finished products, raw materials, stability, and water samples, with strict attention to detail and autonomous work in a regulated environment.

Applicants should have strong math, lab, and computer skills and be prepared for a 12-hour night shift in a sterile manufacturing setting.

Qualifications

• Working knowledge of cGXP requirements and a strong familiarity with production operations.
• Good problem-solving skills.
• Proficient in math, laboratory and computer skills. Understands basic statistics and quality control terminology.

Responsibilities

• Performs testing on a range of samples including finished products, raw materials, stability, in-process and water samples.
• Maintains and troubleshoots testing equipment.
• Supports laboratory investigations, QC method and SOP updates.
• Executes laboratory test protocols to support development and validation activities.
• Responsible for QC data review.
• Provides and follows up on ideas for continuous improvements in laboratory processes.
• Able to take direction and correction when learning procedures and performing analysis.
• Participates in and contributes to the team atmosphere.
• Self-motivated: able to complete all tasks assigned and able to self-assign work without immediate supervision, when appropriate.
• Able to knowledgeably and safely handle hazardous materials.
• Good verbal, written and interpersonal communication and organizational skills.
• The ability to learn and adapt quickly to new priorities and/or situations.
• This position may require operating equipment in various classified/non-classified areas up to a Class 100 aseptic environment and in a laboratory setting.
• This role may require collaboration and communication within the team and with operations groups/QA.
• The role may require individuals to autonomously perform tasks related to environmental monitoring to support regulatory requirements of a sterile manufacturing site, including data review and on-the-floor sampling.

Job description

Brief 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 position involves on-the-floor sampling, data review, and documentation in compliance with cGMP standards. The individual will conduct testing on a variety of samples, including finished products, raw materials, stability, in-process materials, and water systems. Strong attention to detail, adherence to quality standards, and the ability to work autonomously in a regulated environment are essential.

Job Responsibilities

Core Responsibilities

• Performs testing on a range of samples including finished products, raw materials, stability, in-process and water samples.
• Maintains and troubleshoots testing equipment.
• Supports laboratory investigations, QC method and SOP updates.
• Executes laboratory test protocols to support development and validation activities.
• Responsible for QC data review.
• Provides and follows up on ideas for continuous improvements in laboratory processes.
• Able to take direction and correction when learning procedures and performing analysis.
• Participates in and contributes to the team atmosphere.
• Self-motivated: able to complete all tasks assigned and able to self-assign work without immediate supervision, when appropriate.
• Able to knowledgeably and safely handle hazardous materials.
• Good verbal, written and interpersonal communication and organizational skills.
• The ability to learn and adapt quickly to new priorities and/or situations.
• This position may require operating equipment in various classified/non-classified areas up to a Class 100 aseptic environment and in a laboratory setting.
• This role may require collaboration and communication within the team and with operations groups/QA.
• The role may require individuals to autonomously perform tasks related to environmental monitoring to support regulatory requirements of a sterile manufacturing site, including data review and on-the-floor sampling.

Experience & Education

Minimum Qualifications

• Working knowledge of cGXP requirements and a strong familiarity with production operations.
• Good problem-solving skills.
• Proficient in math, laboratory and computer skills. Understands basic statistics and quality control terminology.

Preferred Qualifications

• Bachelor's degree in chemistry, biology or a related field.
• QC chemistry laboratory experience in the pharmaceutical industry.
• Working knowledge of laboratory equipment (including HPLC), operations, and safety.

Physical & Work Environment

• Work is performed onsite in a cGMP manufacturing and laboratory environment, including cleanrooms classified up to Class 100 (ISO 5) aseptic areas.
• Requires gowning and adherence to aseptic behavior requirements for the duration of cleanroom activities.
• Requires standing, walking, bending and reaching for extended periods, and the ability to lift up to 25 pounds.
• Requires the ability to work a rotating 12-hour night shift, including weekends and holidays as scheduled.

Work Schedule:

Night Shift - 6pm - 630am with a 12-hour rotation on a 2 nights on, 2 nights off, 3 nights on, 3 nights off with the rotation starting over.
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 $60,000.00 - $86, 250.00 per year. 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.