Thermo Fisher Scientific Sr Quality Control Analyst in Florence, South Carolina
Serves as a technical expert and represents Quality Control in leading and executing analytical method transfers.
Serves on project teams and manages technical transfer activities within the department including change controls, creation of protocols/reports/methods/specifications and project plans.
Leads analytical projects without supervision; may lead multiple projects, including managing project timelines and deliverables.
Coordinates transfer of methods and processes that meet or exceed the expectations from clients and provide innovation as necessary.
Performs reviews of methods and testing to ensure that methods are validated as appropriate and fit for use to meet Regulatory and Pharmacopeial requirements and support the troubleshooting and performance of assay reviews/trending.
Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices and Safety guidelines. Maintains the necessary compliance status required by company and facility standards.
Liaises with internal scientific, analytical, and laboratory functional areas to meet project and team objectives.
Bachelors of Science in Chemistry, Biochemistry, Biology, or related physical science.
8+ years of progressive scientific experience, including at least 5 years in the pharmaceutical/biopharmaceutical field.
5+ years of experience with chromatographic data acquisition systems (LC/GC) is required.
3+ years of experience in method validation and transfers
5+ years of experience using Waters Empower CDS preferred
In-depth knowledge of a full range of analytical techniques.
Knowledge of regulatory requirements
Strong written and verbal communication skills
Understanding of pharmaceutical manufacturing
Exposure to/knowledge of Quality Assurance, GMPs, Health Authority Regulations and Validation practices/principles
Strong knowledge of GMP, SOPs and quality systems.
Prior regulatory inspection experience for GMP laboratory operations would be a bonus.
While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; sit and to talk, hear or smell. The employee is occasionally required to walk and stoop, or kneel, crouch. The employee must also occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made for persons with disabilities - evaluation to determine fitness will be made by company physician(s). While performing the duties of this job, the employee is:
- Occasionally exposed to various types of chemical substances. (MSDS information is made available for review on an on-going basis).
Employee must comply with all applicable safety and security procedures:
Determine appropriate action beyond guidelines.
Report potentially unsafe conditions.
This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.