Company: Thermo Fisher Scientific Location: West Greenwich, RI Employment Type: Full Time Date Posted: 04/10/2021 Expire Date: 06/14/2021 Job Categories:
Arts, Entertainment, and Media, Computers, Software, Customer Service and Call Center, Information Technology, Manufacturing and Production, Quality Control, Research & Development, Writing/Authoring
Quality Control Lab Analyst
When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.
Location/Division Specific Information
This position is focused on service delivery excellence for Unity Lab Services. Specific activities relative to the job function could include: Support of Research and Development, Technical Development, Manufacturing and QC. This position will utilize the basic functionality of systems and applications relevant to the job function. Strong communication skills are required.
This position is located in West Greenwich, RI
What will you do?
This position is focused on service delivery excellence for UnityTM Lab Services.
Specific activities relative to the job function could include:
Support of Commercial Manufacturing by providing the following services: processing of labware for cleaning and sterilization, Media and Buffer preparation, lab inventory management, Quality Control analysis on manufactured drug product and substance, interpretation of HPLC analysis data, and communication to manufacturing of product Purity, Identity, and Concentration to enable forwards processing of commercial product.
This position will utilize intermediate and advanced functionality of systems and applications relevant to the job function.
The STAT titer portion of this role directly supports commercial manufacturing.
During coverage for STAT Titer, Candidate must be able to work variable shifts including second / third shifts, nights, weekends or holidays in order to accommodate the manufacturing schedule.
Job-Specific Duties may include:
Preparation of drug sample product for sample analysis
Use of validated electronic laboratory sample database to create samples, and maintain sample inventory within a LIMS system
Operator level gowning for entrance and work performed in manufacturing suites
Sample preparation of drug product and drug substance
Operation of Waters and Agilent HPLC analysis systems using SEC, IEC, RPC, and Affinity chromatography methods
HPLC Analysis on drug product and drug substance for Purity, Identify, and Concentration (PIC) for STAT and non-STAT samples
Perform first level troubleshooting on HPLC systems, including change out of external and internal components
Interpret HPLC result data for molecule PIC based Method acceptance criteria
Independent data verification of HPLC analysis product for PIC
Communication with manufacturing management of HPLC analysis results for forward processing of commercial product
Perform Biological Indicator testing on manufacturing samples for microbial growth
At all times, comply with safety guidelines, cGMPs and other applicable regulatory requirements
Ensures that, equipment, materials, processes and procedures comply with cGMP practices and other applicable regulations
Alerts Customer management of quality, compliance, supply and safety risks
Completes required assigned training to permit execution of required tasks
Utilization of Good Documentation Practices in all record keeping
Maintaining metric data for work performed
Perform equipment verifications and calibrations following customer and manufacturer’s protocols
Maintain Quality Control reagents within customer validated Consumable Inventory Management System (CIMS), including adding reagents, uploading C of A, determination of chemical equivalents, creating su-inventories, and discarding of items
Strict adherence to customer Standard Operating Procedures and Method protocols
Perform primary trainer responsibility for customer validated Methods and procedures
Promote a safe work environment through various safety initiatives within functional area
Participate in individual or group projects that can include, cost savings analysis, learning groups, writing job training methods, and leading team meetings
How will you get here? Education/Experience
High School Diploma/GED is required
Bachelor's Degree is required
1-2 year of Quality experience preferred
Must be able to work a flex schedule
Evident understanding of intermediate HPLC principals
Demonstrated verbal, written and presentation skills
Displays a high level of confidentiality for both customer and Thermo Fisher Scientific
Must maintain Thermo Fisher Scientifics’ Four-I Values
Experience in laboratory setting or services preferred
Proven excellence in customer service skills
Detail oriented, problem solver, promotes team environment
Must possess a strong desire to serve the customer, and the interpersonal skills to deal with various levels of personnel at the customer site.
Must possess strong communication skills and customer focus to deliver excellent customer service including maintaining a professional appearance at all times.
Must possess strong analytical skills to interpret scientific data to ensure customer requirements are met.
Must possess the organizational skills to multi-task and meet changing deadlines as needed.
Must be able to use a computer and possess advanced skills in Microsoft Office suite.
Job Families for Job ProfilesLaboratory Services (LABS)
At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
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.