QC Engineer/Scientist I [Remote]

JOB DESCRIPTION

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance, 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.), Will work with hazardous/toxic materials

Job Description

QC Engineer/Scientist I

R-01369952

Site based role in Frederick, MD

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.

Be part of our Quality Control team at Thermo Fisher Scientific, where you'll contribute by ensuring the quality and reliability of products that help make the world healthier, cleaner and safer. You'll perform testing and analysis to support the development of innovative therapeutic products. You'll conduct quality control testing of raw materials, in-process samples, and finished products using various analytical techniques. You'll document and analyze test results, participate in investigations, and contribute to continuous improvement initiatives. This role offers opportunities for professional growth while working with skilled colleagues who share our commitment to excellence and innovation.

Responsibilities:

• Plans and performs quality control testing of reagents and kits through various testing methods such as next-generation sequencing and purification on the Genexus platform
• Follow good laboratory practices and cGMP
• Assist with Out of Specification investigations as appropriate
• Assist with updating QC testing methods, SOPs, and batch record forms to align with current laboratory practices and improvements
• Maintain a team-first mindset and communicate effectively
• Support product development programs, method validation, etc.
• Initiates problem reporting (deviations, non-conformances, failures, corrective and preventive actions) via TrackWise and assists with root cause investigation/analysis for OOS
• Perform peer review of QC data packets
• Ensure the laboratory is well-stocked and resourced
• Supports, embraces, and promotes the Thermo Fisher 4 I values – Integrity, Intensity, Innovation, and Involvement
• Help maintain the Quality Control laboratory in a safe, tidy, and efficient condition and to ensure safe working practices are followed

Minimum Qualifications:

• Skilled in basic molecular biology and/or analytical chemical testing
• Working knowledge of general cGMP lab compliance
• Good pipetting technique
• Strong quality-first mindset
• Ability to perform independently & as part of a team
• Ability to work in dynamic, fast paced team environment
• Excellent communication/interpersonal and presentation skills
• Experience writing & reviewing technical documentation

Preferred Qualifications:

• 1-2 years relevant industry experience or equivalent experience
• Degree in Biochemistry, Chemistry, Molecular Biology, or related degree preferred
• Experience with Next Gen Sequencing
• Previous experience in GMP setting
• Experience in participating in problem notifications, CAPA, Out of Specification investigations, etc.
• Knowledge of 5S system and process improvements

Compensation and Benefits

The salary range estimated for this position based in Maryland is $54,900.00–$82,350.00.

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

For more information on our benefits, please visit: