Quality Specialist II

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

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

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Excellent Benefits Package

Review our company’s Total Rewards

Medical, Dental, & Vision benefits-effective Day 1

Paid Time Off & Holidays

401K Company Match up to 6%

Tuition Reimbursement – eligible after 90 days!

Employee Referral Bonus

Employee Discount Program

Recognition Program

Charitable Gift Matching

Company Paid Parental Leave

Career Advancement Opportunities

Do you have a passion for quality assurance and a drive to ensure outstanding standards? As a Quality Specialist II at Thermo Fisher Scientific, you will play a pivotal role in bridging our quality assurance processes with our external customers. This outstanding opportunity allows you to work in a collaborative environment where your contributions will directly impact our shared success.

Key Responsibilities

• Serve as the Quality Assurance link between Thermo Fisher Scientific and external customers.
• Initiate involvement of appropriate departments, maintaining continuous communication to ensure high standards of work.
• Represent Quality Assurance at customer kick-off meetings.
• Lead customer teleconferences, visits, and audits, providing timely reports and updates.
• Participate in internal audits per the established schedule and procedures.
• Support multiple high-complexity projects with critical timelines.
• Coordinate manufacturing and quality activities associated with exceptions, CAPA, deviations, change control requests, and other documentation.
• Measure and report key performance indicators at both site and customer levels.
• Develop and implement corrective action plans to address areas of concern.

Qualifications

• High School Diploma or GED required. Bachelor's degree in Science, Engineering, or a related field is preferred.

- At least three years of experience in a progressive role within a manufacturing or laboratory environment, preferably in pharmaceutical - API or chemical industries.

• Strong understanding of quality and regulatory requirements in the pharmaceutical (API) industry, including GMPs, FDA regulations, and Good Documentation Practices.
• Experience in process improvement tools and implementation (Six Sigma, Lean Manufacturing, Risk Assessment, Root Cause analysis).
• Proven analytical and quality approach.
• Ability to work in a fast-paced environment with outstanding time management and prioritization skills.
• Outstanding customer service skills and the ability to establish effective working relationships.
• Excellent verbal, written, and presentation skills, including proficiency in technical writing.
• Proficient in the use of computerized systems and software (Outlook, Excel, Word, PowerPoint, Trackwise, SAP) and project management skills.