QC Scientist II
QC Scientist II
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Salary Not Disclosed
1 Vacancy
Job Description
Work Schedule
First Shift (Days)Environmental Conditions
Able to lift 40 lbs. without assistance Adherence to all Good Manufacturing Practices (GMP) Safety Standards Laboratory Setting 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 youll discover meaningful work that makes a positive impact on a global scale. 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 worlds toughest challenges like protecting the environment ensuring our food is safe or helping find cures for cancer.
Location/Division Specific Information
Position reports to the St Louis MO site and supports the Drug Substance Division.
Discover Impactful Work:
In this role you will use numerous analytical tools used for large molecule analysis such as HPLC UPLC and other minor equipments. This work will be supporting GMP manufacturing for early and late state clinical and commercial efforts (InProcess) along with Stability testing and other endeavors requested by the client. This role will require experience in working in a cGMP environment. The candidate should be familiar with using Empower software. MS Office experience is required.
A Day in the Life:
- Perform HPLC/UPLC testing on InProcess DS release DP release DS stability DP Stability and various other nonroutine samples ensuring timely delivery for projects
- Participate in analytical method validation/transfer method establishment/qualification routine and stability analysis.
- Conduct GMP testing in an analytical laboratory environment using HPLC and UPLC test methods (i.e.Reverse Phase SEC Titer concentration CEX etc)
- Compiles data for documentation of test procedures prepares reports. Ensures all testing processes monitoring and departmental documentation meet SOPs and cGMP regulatory standards.
- Participate in the development of new concepts techniques and standards. Involved with assisting in the preparation of CoAs.
- Recognize and report outofspecification/ outoftrend results to laboratory management; recommend solutions.
- Perform all duties in compliance with Standard Operating Procedures Good Manufacturing Practices Good Laboratory Practices and Safety guidelines
- Partake in laboratory activities including safety inspections and client audits in a timely matter.
Keys to Success:
Education
- Required: Bachelors degree in chemical pharmaceutical biology chemistry biotechnology or related field.
Experience
- At least 3 years of related experience in a regulated environment required.
- HPLC experience in pharma or a related relevant field required.
Knowledge Skills Abilities
- Flexibility.
- Organization and planning skills.
- Ability to work in a team.
- Attention to details.
- Positive demeanor.
- KnowledgeMS Office program.
- Indepth knowledge of the most common analytical techniques and required instrumentation.
- Knowledge of notions and laboratory computer programs(Empower LIMs TrackWise).
Benefits
We offer competitive remuneration annual incentive plan bonus healthcare and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative forwardthinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation!
Employment Type
Full-Time
