QC Engineer/Scientist I

Thermo Fisher Scientific•Frederick, MD

4d•Onsite

About The Position

The QC Engineer/Scientist I is a site-based role in Frederick, Maryland, on Thermo Fisher Scientific’s Quality Control team. The position supports the development of therapeutic products by testing reagents and kits and helping ensure product quality and reliability. Testing may include next-generation sequencing and purification on the Genexus platform. The role also contributes to method validation, product development programs, investigations, and continuous improvement while following good laboratory practices and cGMP requirements. The employee documents and reviews testing data, assists with out-of-specification investigations and root-cause analysis, and helps maintain current laboratory procedures and records. The position works in a laboratory setting with hazardous or toxic materials and requires adherence to GMP safety standards and use of appropriate personal protective equipment. The standard work schedule is Monday through Friday.

Requirements

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

Nice To Haves

One to two years of relevant industry experience or equivalent experience.
Degree in Biochemistry, Chemistry, Molecular Biology, or a related field.
Experience with next-generation sequencing.
Previous experience in a GMP setting.
Experience participating in problem notifications, CAPA, and out-of-specification investigations.
Knowledge of the 5S system and process improvements.

Responsibilities

Plan and perform quality control testing of reagents and kits using methods such as next-generation sequencing and purification on the Genexus platform.
Follow good laboratory practices and cGMP requirements.
Assist with out-of-specification investigations as appropriate.
Help update QC testing methods, SOPs, and batch record forms to reflect current laboratory practices and improvements.
Communicate effectively and maintain a team-first mindset.
Support product development programs and method validation.
Initiate problem reports for deviations, non-conformances, failures, and corrective and preventive actions through TrackWise; assist with root-cause investigation and analysis for out-of-specification results.
Perform peer reviews of QC data packets.
Ensure the laboratory is well-stocked and resourced.
Promote Thermo Fisher’s 4 I values: Integrity, Intensity, Innovation, and Involvement.
Help maintain the QC laboratory in a safe, tidy, and efficient condition and follow safe working practices.

Benefits

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 of paid time off (PTO).
10 paid holidays annually.
Paid parental leave, including 3 weeks for bonding and 8 weeks for caregiver leave.
Accident and life insurance.
Short- and long-term disability in accordance with company policy.
Competitive 401(k) U.S. retirement savings plan.
Employees’ Stock Purchase Plan (ESPP), offering eligible colleagues the opportunity to purchase company stock at a discount.
Variable annual bonus may be available based on company, team, and/or individual performance results in accordance with company policy.