Night-Shift QC Analyst II — cGMP & Data Review

Resilience; Port Union (OH); Vor Ort; USD 60.000 - 86.000; Vollzeit

Benefits dieser Stelle

Annual cash bonus

401(k) plan with company match

Healthcare benefits (medical, dental,

Vision coverage

Tuition reimbursement

Paid vacation and holidays

Zusammenfassung

Resilience, a biomanufacturing company, is seeking a Laboratory QC professional to perform testing on a variety of samples, review data, and document in a cGMP environment. The role requires full adherence to quality standards and the ability to work autonomously on a rotating 12-hour night shift onsite.

You will operate and troubleshoot lab equipment, support investigations and SOP updates, and participate in continuous improvement within a regulated production setting.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

cGXP knowledge

Laboratory testing

Quality control

Data review

Attention to detail

Autonomous work

Ausbildung

Bachelor's degree in chemistry, biology or a related field

Tools

HPLC

Jobbeschreibung

Resilience, a biomanufacturing company, is seeking a Laboratory QC professional to perform testing on a variety of samples, review data, and document in a cGMP environment. The role requires full adherence to quality standards and the ability to work autonomously on a rotating 12-hour night shift onsite.

You will operate and troubleshoot lab equipment, support investigations and SOP updates, and participate in continuous improvement within a regulated production setting.