Job ID :
US - Rhode Island - West Greenwich
- 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.