Night-Shift QC Analyst II — cGMP Lab

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

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.