Quality Specialist I - QOTF

Thermo Fisher Scientific Inc.; Cincinnati (OH); On-site; USD 60,000 - 80,000; Full time

Job summary

An established industry player is seeking a dedicated Quality Assurance professional to ensure compliance with FDA regulations and Good Manufacturing Practices. In this role, you will support Operations and Quality Operations departments by investigating batches and assisting in corrective actions for process deviations. You will conduct GMP inspections and ensure that operations maintain a clean and orderly environment. This position offers a unique opportunity to contribute to high-quality standards in a fast-paced manufacturing setting. If you have a keen eye for detail and a passion for quality, this role is perfect for you.

Qualifications

• 3+ years of QA experience required.
• 2+ years in Manufacturing or GMP environment preferred.

Responsibilities

• Assist in investigations to ensure compliance with FDA regulations.
• Conduct GMP inspections and maintain cleanliness in operations.

Skills

Problem Solving

Attention to Detail

Writing Skills

GMP Knowledge

Education

High School Diploma/GED

Bachelor's Degree in Science

Job description

Work Schedule

12 hr shift/days

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. Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.). Standing for full shift.

Job Description

Summary:

Assists in the investigation and monitors Operations and Quality Operations departments to assure that FDA current Good Manufacturing Practices, company SOPs and product registrations are followed and maintained. Assists in the investigations of batches, preps, lots, equipment, and facilities as required per the Code of Federal Regulations. Assists the Operations and Quality Operations departments in satisfying all FDA requirements. This role will support CPI, Granulation, and Dispensing.

Shift:

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

Essential Functions:

• Acts as a resource to operations teams and problem-solving groups and aids in resolution of problems.
• Assists Operations and Quality Operations in implementing corrective action for process deviations, assisting with CAPA initiatives.
• Conducts GMP inspections of facilities to assure compliance with the current GMP regulations.
• Performs housekeeping inspections to assure Operations is maintaining work areas in an orderly and clean manner.
• Assures that operators are following written instructions and methods and procedures via real-time record review.

Education:

• High School Diploma/GED Required
• Bachelors Degree in Science or applicable field preferred.

Experience:

• 3+ years of QA experience required.
• 2+ years experience in Manufacturing, Process Engineering, Engineering services and/or GMP environment preferred.

Competencies:

• Thorough knowledge of OSD manufacturing, including equipment and process understanding.
• Excellent problem solving and writing skills.
• Ability to work on multiple projects simultaneously, adaptable for a fast-paced fluid environment.
• Strong attention to detail.
• Works well independently and leads collaboratively within team and cross-functionally.

Required:

Requires a basic understanding of the practices, principles, and theory of GMP Services.

Physical Requirements:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.