Quality Specialist I - QOTF

Thermo Fisher Scientific; Cincinnati (OH); On-site; USD 45,000 - 70,000; Full time

Job summary

An established industry player is seeking a Quality Specialist I to ensure compliance with FDA regulations and Good Manufacturing Practices. In this role, you will assist in investigations and monitor operations to maintain high-quality standards. Your expertise will be crucial in implementing corrective actions and conducting inspections to uphold regulatory compliance. This position offers a dynamic work environment where your problem-solving skills and attention to detail will be highly valued. Join a team dedicated to excellence and make a significant impact in the quality assurance field.

Qualifications

• 3+ years of QA experience required.
• Knowledge of OSD manufacturing and GMP compliance.

Responsibilities

• Assist in investigations and monitor compliance with FDA regulations.
• Conduct GMP inspections and ensure adherence to procedures.

Skills

Problem-solving

Attention to detail

Writing skills

Education

High School Diploma/GED

Bachelor's Degree in Science

Job description

Join to apply for the Quality Specialist I - QOTF role at Thermo Fisher Scientific

2 days ago Be among the first 25 applicants

Get AI-powered advice on this job and more exclusive features.

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards. Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair, etc. Allowed PPE includes safety glasses, gowning, gloves, lab coat, ear plugs, etc. Standing for full shift is required.

Work Schedule

12 hr shift/days

Summary

Assists in investigations and monitors Operations and Quality Operations departments to ensure compliance with FDA current Good Manufacturing Practices, company SOPs, and product registrations. Supports investigations of batches, preps, lots, equipment, and facilities as per CFR. Supports FDA compliance in CPI, Granulation, and Dispensing.

Shift

Monday - Wednesday 6:00am - 6:30pm

Essential Functions

• Acts as a resource to operations teams and problem-solving groups, aiding in resolution of issues.
• Assists in implementing corrective actions for process deviations and CAPA initiatives.
• Conducts GMP inspections to ensure regulatory compliance.
• Performs housekeeping inspections to maintain clean work areas.
• Ensures operators follow written instructions and procedures via real-time record review.

Education

• High School Diploma/GED required.
• Bachelor's Degree in Science or applicable field preferred.

Experience

• 3+ years of QA experience required.
• 2+ years in manufacturing, process engineering, or GMP environment preferred.

Competencies

• Knowledge of OSD manufacturing, equipment, and processes.
• Strong problem-solving and writing skills.
• Ability to manage multiple projects in a fast-paced environment.
• Attention to detail.
• Ability to work independently and collaboratively.

Physical Requirements

Must have ambulatory skills, physical coordination, ability to stand, walk, stoop, kneel, crouch, lift 10-35 pounds, and operate equipment. Visual acuity for reading and operating machinery. Ability to sit, reach, talk, and hear for prolonged periods.