Work Schedule

First 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

At Thermo Fisher Scientific, we are offering a unique opportunity for an Engineer/Scientist I, QC to join our team. As the world leader in serving science, our company is dedicated to impactful work, innovative thinking, and a culture that values passion and unique contributions. By joining us, you will have the chance to make a real difference in the world while building a fulfilling career.

Location/Division Specific Information

This position is based in Miami, FL site, a part of our Biologicals and Chemicals Division.

Discover Impactful Work

As an Engineer/Scientist I, QC, you will have a significant impact on our organization. Your role will involve conducting chemistry tests on raw materials, finished products, and stability samples. You will actively contribute to enhancing processes and streamlining workflows in the chemistry lab. Your work will be guided by our 4i values: integrity, innovation, intensity, and involvement. Additionally, you will be responsible for ensuring that our products and services meet rigorous quality standards and adhere to global regulatory requirements.

A Day in the Life

In this role, you will:

• Develop and implement Standard Operating Procedures (SOPs), Work Instructions (WIN), and validation protocols.

• Review testing results, complete testing summary reports, and perform data entry.

• Maintain Chemistry Laboratory inventory by ordering supplies, reagents, equipment, and materials as needed.

• Support method validation and analytical testing of raw materials and bulk finished goods.

• Responsible for maintaining laboratory notebooks and records according to Good Laboratory and Documentation Practices.

• Support the Quality Supervisor/Manager in conducting internal audits and Gemba Walks.

• Coordinate Chemistry Lab activities to achieve QC testing delivery goals.

• Initiate OOS report and conduct investigations per applicable site procedures.

• Maintain Chemistry Lab audit readiness following the 5s approach.

• Complete other duties as assigned by your manager.

Education

To qualify for this role, you should have a minimum of a BS degree in a technical subject, preferably in Life Sciences such as Microbiology, Biochemistry, or Molecular Biology. Equivalent experience will also be considered.

Experience

You should have a minimum of 2-4 years of experience in a Chemistry or Analytical testing lab, preferably in a Pharmaceutical, Biotech/Aseptic filling, or similar environment. You should also have a proven understanding of quality system regulations and requirements, including ISO 9001, 21 CFR Part 211/210, Part 820, and cGMP/GLP. Some experience with analytical lab testing is also required.

Knowledge, Skills, Abilities

To be successful in this role, you should have the following:

• Strong application of technical principles, practices, and procedures.

• Effective communication skills at all levels, both written and verbal.

• Effective skills in analytical thinking and problem-solving.

• Ability to perform multiple tasks and effectively manage conflict.

• Ability to work in teams to obtain results, self-motivated/directed, ability to organize activities with minimal supervision.

• Demonstrates strong commitment, responsibility, honesty, and commitment to effective operations.

Physical Requirements / Work Environment

This role requires the ability to work safely with materials and equipment, including exposure to fumes and chemicals. Various levels of gowning are required, including Personal Protective Equipment (PPE) such as lab coats, hair/beard covers, shoe covers, gloves, ear protection, eye protection, and cleanroom suits and head coverings as needed.

Benefits

We offer competitive remuneration, an annual incentive plan bonus, healthcare, and a range of employee benefits. By joining Thermo Fisher Scientific, you will be part of an innovative and forward-thinking organization with outstanding career and development prospects. Our company culture values integrity, intensity, involvement, and innovation.

Apply today! http://jobs.thermofisher.com

To apply for this exciting opportunity, please visit our website at the provided link and submit your application. We look forward to reviewing your qualifications and considering you for this position.

Accessibility/Disability Access

Thermo Fisher Scientific is committed to providing accessibility services for job seekers who require accommodations in the application process. If you have a disability and need assistance, whether due to hearing, vision, mobility, or cognitive impairments, please contact us at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation. We are here to support you throughout the job application process.

• This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes will not receive a response.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.