Thermo Fisher Scientific Quality Control Analytical Specialist in West Greenwich, Rhode Island
Follows well defined procedures as outlined by Best Practices, SOP’s & work instructions. Take direction from Site Supervisor/Manager (and Team Lead) regarding daily duties.
Makes decisions and utilizes available resources to meet customer requirements, independently.
Analyzes/maintains/reconciles various customer and Thermo Fisher reports to ensure customer and Thermo Fisher requirements are met.
Communicates with supervisor any customer issues or potential problems.
Promotes personal growth and development by staying abreast of new policies and enhancements without the presence of site trainer and management team.
Listens to customer concerns, effectively diffuses dissatisfaction, and quickly identifies course of action with a goal of first call resolution within established turnaround times.
Works effectively with a diverse cross-functional team.
Embraces Practical Process Improvement (PPI) methodologies.
Utilizes systems as required by job function.
Represents Thermo Fisher Scientific at all times throughout customer locations, professionally and positively.
Performs other duties as assigned by management.
Adhere to safety requirements
Support the Quality Management System by
Development, maintenance and full adherence to departmental work instructions, standard operating procedures (SOP’s) in fulfillment of the requirements of our Quality Management System and the expectations of our interested parties (internal / external).
·Identify and report quality or compliance concerns to management and the quality function and take immediate actions to remedy.
Complete all planned or unplanned quality & compliance training requirements within defined deadlines
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
Master's Degree OR
Bachelor's Degree & 2 years of Quality experience OR
Associate's degree & 6 years of Quality experience OR
High school diploma/GED & 8 years of Quality experience
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 environmen
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 intermediate skills in Microsoft Office suite.
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.