Quality Specialist III

JOB DESCRIPTION

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, 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 5%

Tuition Reimbursement – eligible after 90 days!

Employee Referral Bonus

Employee Discount Program

Recognition Program

Charitable Gift Matching

Company Paid Parental Leave

Career Advancement Opportunities

DESCRIPTION:
Join Thermo Fisher Scientific in ensuring the highest quality standards across our operations. As a Quality Specialist III, you will work within the Particle Analysis Group to support mission of enabling customers to make the world healthier, cleaner and safer. This role involves training and certifying visual inspectors from manufacturing and quality to ensure they are knowledgeable and able to detect defective syringes and vials. This role will also involve the creation, inspection, and maintenance of syringe and vial defect kits used for training, certification, and validation of manual and automated inspection processes. This role may involve laboratory analysis of particulate matter found in filled containers or samples using analytical equipment such as stereomicroscope, infrared spectroscopy, and scanning electron microscopy.

REQUIREMENTS:
• Advanced Degree plus 1 year of experience, or bachelor's degree plus 2-3 years of experience in quality assurance or manufacturing specifically involving visual inspection within regulated industries (pharmaceutical, medical device, biotech preferred)
• Preferred Fields of Study: Life Sciences, Engineering, Chemistry, Biology or related technical field
• Strong knowledge of GMP/GxP regulations, ISO standards (9001/13485), and other relevant quality system requirements
• Experience with quality management systems, CAPA processes, deviation management, and change control
• Experience with training and/or certification of operators

• Demonstrated expertise in visual inspection of syringe and/or vial finished products
• Strong technical writing skills for authoring SOPs, protocols, investigation reports, and other quality documentation
• Advanced problem-solving abilities and attention to detail
• Excellent verbal and written communication skills
• Strong interpersonal skills with ability to collaborate across functions and levels
• Proficiency with quality systems software and Microsoft Office Suite
• Ability to work independently and guide cross-functional teams
• Physical ability to work in manufacturing environments with PPE requirements as needed
• Laboratory experience with particulate investigation experience preferred

Compensation and Benefits

The salary range estimated for this position based in New Jersey is $90,900.00–$136,350.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs

• Employee assistance and family support programs, including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

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